Certificate of analysis · Apex Laboratory

Lipo-C 10 ml

APX-2026-0517-L

COA issue date: May 17, 2026
Report ID: APX-COA-2026-0517-L
Issuing laboratory: Apex Laboratory
Configuration: Lipo-C 10 ml
Authorized by: K. Norwood
Documented endpoints: 94 across 21 test groups

Download PDF Preview

View Lipo-C 10 ml product

For laboratory research use only. The issue date identifies this certificate; it is not a testing date.

Preview report pages

Analytical record

Results & specifications

Download result tables

T01Identity and structure

Test / endpoint	Result	Acceptance criterion	Method
Orthogonal identity against specified reference	Conforms to the assigned reference; see identity basisPASS	Conforms to the specified acceptance criterion	M-T01-DEFAULT
Supporting analytical detail for Orthogonal identity against specified reference Sample units 3 finished containers Analytical replicates 2 neutral average mass Not assigned: construct/distribution or no supported unique species neutral monoisotopic mass Not assigned — see component-specific HRMS records; a reference mass is not a measured neutral massMethod and sample context; reference facts are in Identity Reference. observed mz Not assigned — heterogeneous construct or no defined ion; orthogonal identity documented insteadMethod and sample context; reference facts are in Identity Reference. mass tolerance +/-5 ppm for an explicitly defined monoisotopic ion; not 5 Da.Method and sample context; reference facts are in Identity Reference. reduced deglycosylated or intact Intact specified parent for defined compounds; glycoproteins and PEG retain the specified population heterogeneity. No single exact intact glycoprotein mass is invented.Method and sample context; reference facts are in Identity Reference. stereochemistry method Component-specific chiral amino acid analysis or orthogonal structure comparison, where applicable; HRMS cannot distinguish stereoisomers.Method and sample context; reference facts are in Identity Reference. identity standard traceability RS-2703; internal standard, not a purchased certified reference material
Orthogonal fingerprint similarityspectrum/peptide-map comparison; score is not proof of stereochemistry	0.9994 similarity (0-1)PASS	>= 0.995similarity (0-1)	M-T01-DEFAULT
Supporting analytical detail for Orthogonal fingerprint similarity Sample units 3 finished containers Analytical replicates 2
L-Methionine component-specific HRMS mass error[M+H]+; exact ion definition independent of whole-blend identity. Reference formula C5H11NO2S.	0.00997 ppmPASS	-5 to 5ppm	M-T01-BLEND-SELECTIVE-HRMS
Supporting analytical detail for L-Methionine component-specific HRMS mass error Sample units 3 finished containers Analytical replicates 1
myo-Inositol component-specific HRMS mass error[M+Na]+; exact ion definition independent of whole-blend identity. Reference formula C6H12O6.	0.05006 ppmPASS	-5 to 5ppm	M-T01-BLEND-SELECTIVE-HRMS
Supporting analytical detail for myo-Inositol component-specific HRMS mass error Sample units 3 finished containers Analytical replicates 1
Choline chloride component-specific HRMS mass error[C5H14NO]+ (choline cation; chloride excluded); exact ion definition independent of whole-blend identity. Reference formula C5H14ClNO.	0.09002 ppmPASS	-5 to 5ppm	M-T01-BLEND-SELECTIVE-HRMS
Supporting analytical detail for Choline chloride component-specific HRMS mass error Sample units 3 finished containers Analytical replicates 1

T02Chromatographic purity

Test / endpoint	Result	Acceptance criterion	Method
L-methionine chromatographic puritySingle analyte method scope; intended blend co-components and excipients excluded by analyte-specific selectivity, not denominator manipulation	99.938 % integrated detector areaPASS	99.7 to 100% integrated detector area	M-T02-HILIC-CAD
Supporting analytical detail for L-methionine chromatographic purity Sample units 3 finished containers Analytical replicates 2 gradient or separation conditions Analyte-specific starting method in Method Profiles; retention time is anchored to the same component across sizes, with a small run shift.Method and sample context; reference facts are in Identity Reference. detector and wavelength Peptides: DAD at 214 nm. Proteins: SEC with UV detection at 280 nm. Nonchromophoric analytes: CAD, with detector-area reporting explicitly distinguished from mass fraction.Method and sample context; reference facts are in Identity Reference. main peak retention time 15.989 min integration threshold Reporting threshold: 0.010%; LOQ: 0.005%; LOD: 0.002%, for the single-analyte method.Method and sample context; reference facts are in Identity Reference. main peak area 9991300 counts total integrated area 10000000 counts unresolved or excluded peaks Only specified co-components/vehicle/excipients excluded using selective methods; unknown U1/U2/U3 remain in analyte-method denominator.Method and sample context; reference facts are in Identity Reference.
myo-inositol chromatographic puritySingle analyte method scope; intended blend co-components and excipients excluded by analyte-specific selectivity, not denominator manipulation	99.922 % integrated detector areaPASS	99.7 to 100% integrated detector area	M-T02-HILIC-CAD
Supporting analytical detail for myo-inositol chromatographic purity Sample units 3 finished containers Analytical replicates 2
Choline chloride chromatographic puritySingle analyte method scope; intended blend co-components and excipients excluded by analyte-specific selectivity, not denominator manipulation	99.913 % integrated detector areaPASS	99.7 to 100% integrated detector area	M-T02-HILIC-CAD
Supporting analytical detail for Choline chloride chromatographic purity Sample units 3 finished containers Analytical replicates 2

T05Related substances and degradants

Test / endpoint	Result	Acceptance criterion	Method
L-methionine Unknown U1Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.031 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for L-methionine Unknown U1 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2 impurity identity status U1, U2 and U3 are unassigned peaks. Chemically named degradants appear only in specific orthogonal records when justified.Method and sample context; reference facts are in Identity Reference. reporting threshold 0.010% integrated analyte-specific detector responseMethod and sample context; reference facts are in Identity Reference. relative response factor 1.00 assumed only for area reporting; not sufficient for impurity mass-fraction reportingMethod and sample context; reference facts are in Identity Reference. degradation or process origin if known Unknown peak origin; peak position does not establish oxidation, deamidation or a synthesis byproduct.Method and sample context; reference facts are in Identity Reference.
L-methionine Unknown U2Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.019 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for L-methionine Unknown U2 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
L-methionine Unknown U3Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.012 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for L-methionine Unknown U3 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
L-methionine total related peaksSum of U1+U2+U3; purity plus related areas = 100%	0.062 % integrated detector areaPASS	<= 0.3% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for L-methionine total related peaks Sample units 3 finished containers Analytical replicates 2
myo-inositol Unknown U1Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.039 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for myo-inositol Unknown U1 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
myo-inositol Unknown U2Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.023 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for myo-inositol Unknown U2 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
myo-inositol Unknown U3Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.016 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for myo-inositol Unknown U3 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
myo-inositol total related peaksSum of U1+U2+U3; purity plus related areas = 100%	0.078 % integrated detector areaPASS	<= 0.3% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for myo-inositol total related peaks Sample units 3 finished containers Analytical replicates 2
Choline chloride Unknown U1Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.043 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for Choline chloride Unknown U1 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
Choline chloride Unknown U2Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.026 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for Choline chloride Unknown U2 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
Choline chloride Unknown U3Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.018 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for Choline chloride Unknown U3 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 finished containers Analytical replicates 2
Choline chloride total related peaksSum of U1+U2+U3; purity plus related areas = 100%	0.087 % integrated detector areaPASS	<= 0.3% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for Choline chloride total related peaks Sample units 3 finished containers Analytical replicates 2

T03Active content and assay

Test / endpoint	Result	Acceptance criterion	Method
L-methionine active contentAssigned component material basis; excludes vehicle/excipient/water; salt basis explicitly in identity specification	250.15 mg/vialPASS	245 to 255mg/vial	M-T03-DEFAULT
Supporting analytical detail for L-methionine active content Sample units 3 finished containers Analytical replicates 2 quantitative reference standard RS-2703; independent component standards for blends; not a real purchased CRMMethod and sample context; reference facts are in Identity Reference. standard assigned content 99.90% mass content for the chemical reference. An IU reference uses assigned activity; it is never described as 99.90% IU purity.Method and sample context; reference facts are in Identity Reference. sample preparation volume 500 mL dilution factor 10 fold water correction Water excluded by calibration to active-equivalent standard; moisture separately measured. No area-purity times gross-fill calculation.Method and sample context; reference facts are in Identity Reference. counterion correction Parent-equivalent content unless explicit iodide/choline chloride salt or GHK complex basis. Counterion/metal composition separately quantified.Method and sample context; reference facts are in Identity Reference. gross fill mass No mass is inferred from IU or liquid volume; separate formulation fill quantity appliesMethod and sample context; reference facts are in Identity Reference. active material basis mg per capsule or vial on the explicitly specified material basis; IU on the assigned biological-activity basis. Package count and package total are reported separately.Method and sample context; reference facts are in Identity Reference.
L-methionine label claim assayIndependent calibrated amount / nominal amount x 100; not chromatographic area purity	100.06 % label claimPASS	98 to 102% label claim	M-T03-DEFAULT
Supporting analytical detail for L-methionine label claim assay Sample units 3 finished containers Analytical replicates 2
L-methionine concentrationAmount per nominal 10 mL fill	25.015 mg/mLPASS	24.5 to 25.5mg/mL	M-T03-DEFAULT
Supporting analytical detail for L-methionine concentration Sample units 3 finished containers Analytical replicates 2
myo-inositol active contentAssigned component material basis; excludes vehicle/excipient/water; salt basis explicitly in identity specification	499.96 mg/vialPASS	490 to 510mg/vial	M-T03-DEFAULT
Supporting analytical detail for myo-inositol active content Sample units 3 finished containers Analytical replicates 2
myo-inositol label claim assayIndependent calibrated amount / nominal amount x 100; not chromatographic area purity	99.992 % label claimPASS	98 to 102% label claim	M-T03-DEFAULT
Supporting analytical detail for myo-inositol label claim assay Sample units 3 finished containers Analytical replicates 2
myo-inositol concentrationAmount per nominal 10 mL fill	49.996 mg/mLPASS	49 to 51mg/mL	M-T03-DEFAULT
Supporting analytical detail for myo-inositol concentration Sample units 3 finished containers Analytical replicates 2
Choline chloride active contentAssigned component material basis; excludes vehicle/excipient/water; salt basis explicitly in identity specification	500.875 mg/vialPASS	490 to 510mg/vial	M-T03-DEFAULT
Supporting analytical detail for Choline chloride active content Sample units 3 finished containers Analytical replicates 2
Choline chloride label claim assayIndependent calibrated amount / nominal amount x 100; not chromatographic area purity	100.175 % label claimPASS	98 to 102% label claim	M-T03-DEFAULT
Supporting analytical detail for Choline chloride label claim assay Sample units 3 finished containers Analytical replicates 2
Choline chloride concentrationAmount per nominal 10 mL fill	50.0875 mg/mLPASS	49 to 51mg/mL	M-T03-DEFAULT
Supporting analytical detail for Choline chloride concentration Sample units 3 finished containers Analytical replicates 2

T04Blend composition

Test / endpoint	Result	Acceptance criterion	Method
L-methionine component identity	Conforms to specified component identityPASS	Conforms to the specified acceptance criterion	M-T04-DEFAULT
Supporting analytical detail for L-methionine component identity Sample units 3 finished containers Analytical replicates 2 component label amount L-methionine=250 mg; myo-inositol=500 mg; Choline chloride=500 mgMethod and sample context; reference facts are in Identity Reference. component measured amount L-methionine=250.150000 mg; myo-inositol=499.960000 mg; Choline chloride=500.875000 mgMethod and sample context; reference facts are in Identity Reference. component quantitative standard Separate RS component standards; content and response are assigned independently for each component.Method and sample context; reference facts are in Identity Reference. coelution assessment Selective component extraction and separation are assumed verified in the placebo and spiked blend; a whole-blend peak is not used for every analyte.Method and sample context; reference facts are in Identity Reference. component ratio basis Mass ratio applies only to components labeled in mg. FSH and LH IU are separate bioactivity units and are not added to milligrams.Method and sample context; reference facts are in Identity Reference.
L-methionine component contentSame independent component assay as T03, not a second independent test	250.15 mg/vialPASS	245 to 255mg/vial	M-T04-DEFAULT
Supporting analytical detail for L-methionine component content Sample units 3 finished containers Analytical replicates 2
myo-inositol component identity	Conforms to specified component identityPASS	Conforms to the specified acceptance criterion	M-T04-DEFAULT
Supporting analytical detail for myo-inositol component identity Sample units 3 finished containers Analytical replicates 2
myo-inositol component contentSame independent component assay as T03, not a second independent test	499.96 mg/vialPASS	490 to 510mg/vial	M-T04-DEFAULT
Supporting analytical detail for myo-inositol component content Sample units 3 finished containers Analytical replicates 2
Choline chloride component identity	Conforms to specified component identityPASS	Conforms to the specified acceptance criterion	M-T04-DEFAULT
Supporting analytical detail for Choline chloride component identity Sample units 3 finished containers Analytical replicates 2
Choline chloride component contentSame independent component assay as T03, not a second independent test	500.875 mg/vialPASS	490 to 510mg/vial	M-T04-DEFAULT
Supporting analytical detail for Choline chloride component content Sample units 3 finished containers Analytical replicates 2
L-Methionine isolated component identity definition(S)-2-amino-4-(methylthio)butanoic acid; L-methionine, unoxidized thioether. Reference HILIC retention and chiral amino-acid assay; distinguish methionine sulfoxide/sulfone and D-methionine.	Conforms to the stated component referencePASS	Conforms to the specified acceptance criterion	M-T04-BLEND-SELECTIVE-IDENTITY
Supporting analytical detail for L-Methionine isolated component identity definition Sample units 3 finished containers Analytical replicates 2
myo-Inositol isolated component identity definitionmyo-Inositol stereoisomer of cyclohexane-1,2,3,4,5,6-hexol; not D-chiro-inositol. Reference HILIC retention and solution NMR stereoisomer fingerprint; sodium adduct alone cannot distinguish inositol isomers.	Conforms to the stated component referencePASS	Conforms to the specified acceptance criterion	M-T04-BLEND-SELECTIVE-IDENTITY
Supporting analytical detail for myo-Inositol isolated component identity definition Sample units 3 finished containers Analytical replicates 2
Choline chloride isolated component identity definition2-Hydroxy-N, N, N-trimethylethanaminium chloride: one choline cation and one chloride anion. Choline-cation identity plus independent chloride IC assay; neither a protonated intact salt nor chloride-free mass is the weighed salt content.	Conforms to the stated component referencePASS	Conforms to the specified acceptance criterion	M-T04-BLEND-SELECTIVE-IDENTITY
Supporting analytical detail for Choline chloride isolated component identity definition Sample units 3 finished containers Analytical replicates 2

T15Unit uniformity

Test / endpoint	Result	Acceptance criterion	Method
L-methionine individual-unit meanspecified sample/form only	100.06 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for L-methionine individual-unit mean Sample units 10 finished containers Analytical replicates 1 physical unit count 1 Explicit context; see valueMethod and sample context; reference facts are in Identity Reference. unit statistical summary Mean, sample SD, RSD, M, k and AV are calculated from 10 individual observations; AV for a multidose liquid is descriptive only.Method and sample context; reference facts are in Identity Reference. sampling plan 10 independent units per configuration, with component assays from the same units; separate from the three-unit composite assay.Method and sample context; reference facts are in Identity Reference.
L-methionine individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3522 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for L-methionine individual-unit RSD Sample units 10 finished containers Analytical replicates 1
myo-inositol individual-unit meanspecified sample/form only	99.992 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for myo-inositol individual-unit mean Sample units 10 finished containers Analytical replicates 1
myo-inositol individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3524 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for myo-inositol individual-unit RSD Sample units 10 finished containers Analytical replicates 1
Choline chloride individual-unit meanspecified sample/form only	100.175 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for Choline chloride individual-unit mean Sample units 10 finished containers Analytical replicates 1
Choline chloride individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3518 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for Choline chloride individual-unit RSD Sample units 10 finished containers Analytical replicates 1
Mean extractable volumefill specification; no injection volume recommendation	10 mL/containerPASS	9.9 to 10.2mL/container	M-T15-DEFAULT
Supporting analytical detail for Mean extractable volume Sample units 10 finished containers Analytical replicates 1

T06Water content

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — Water is the formulation vehicle; residual-moisture percentage would misdescribe an aqueous formulation. Vehicle quantity is specified separately.N/A — justified	Not applicable — Water is the formulation vehicle; residual-moisture percentage would misdescribe an aqueous formulation. Vehicle quantity is specified separately.	M-T06-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 finished containers Analytical replicates 0 water method Not applicable — Water is the formulation vehicle; residual-moisture percentage would misdescribe an aqueous formulation. Vehicle quantity is specified separately.Outside the defined test scope. sample handling Not applicable — Water is the formulation vehicle; residual-moisture percentage would misdescribe an aqueous formulation. Vehicle quantity is specified separately.Outside the defined test scope. dry basis correction Not applicable — Water is the formulation vehicle; residual-moisture percentage would misdescribe an aqueous formulation. Vehicle quantity is specified separately.Outside the defined test scope.

T07Counterions and associated species

Test / endpoint	Result	Acceptance criterion	Method
Chloride identity and stoichiometric consistencyCholine chloride; chloride is intentional, not a toxic elemental impurity	Conforms to specified chloride-containing componentPASS	Conforms to the specified acceptance criterion	M-T07-DEFAULT
Supporting analytical detail for Chloride identity and stoichiometric consistency Sample units 3 finished containers Analytical replicates 2 counterion identity Acetate measured as a process residue or associated counterion; intentional chloride, copper or cobalt is specified separately, where applicable.Method and sample context; reference facts are in Identity Reference. salt or solvate specification See the exact material basis in Identity Reference; no arbitrary water or acetate molecule is appended to the reference molecular formula.Method and sample context; reference facts are in Identity Reference.
Choline chloride: independently assayed chlorideIndependent chloride IC result compared with measured choline chloride content; mass fraction uses Cl35.45 / salt139.62. Chloride is intentional.	127.174 mg Cl/vialRecorded numeric value: 127.173892PASS	124.63 to 129.717Lower limit: 124.6304138018756Upper limit: 129.7173694672583mg Cl/vial	M-T07-CHLORIDE-IC
Supporting analytical detail for Choline chloride: independently assayed chloride Sample units 3 finished containers Analytical replicates 2
Choline:chloride stoichiometric consistencyRatio of independent cation/anion assay means; recovery-controlled measurement.	1 mol chloride/mol cholinePASS	0.98 to 1.02mol chloride/mol choline	M-T07-CHLORIDE-IC
Supporting analytical detail for Choline:chloride stoichiometric consistency Sample units 3 finished containers Analytical replicates 2

T08Residual solvents

Test / endpoint	Result	Acceptance criterion	Method
MethanolMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	21.738 ug/mL formulationPASS	<= 3000ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Methanol Limit of detection 1 ug/mL formulation Limit of quantitation 3 ug/mL formulation Sample units 3 finished containers Analytical replicates 2 solvent identity Methanol, acetonitrile, dichloromethane, DMF, ethanol, acetone, ethyl acetate, toluene, n-hexane and benzene.Method and sample context; reference facts are in Identity Reference. sample preparation 0.1000 g of dry formulation or 1.000 mL of liquid, prepared to a final extract volume of 10.00 mL; headspace equilibration at 80 C for 30 min.Method and sample context; reference facts are in Identity Reference. panel scope Explicit ten-solvent teaching panel; additional process solvents require a process-specific risk assessment.Method and sample context; reference facts are in Identity Reference.
AcetonitrileMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	8.76 ug/mL formulationPASS	<= 410ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Acetonitrile Limit of detection 0.3 ug/mL formulation Limit of quantitation 1 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
DichloromethaneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	3.562 ug/mL formulationPASS	<= 600ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Dichloromethane Limit of detection 0.2 ug/mL formulation Limit of quantitation 0.6 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
N, N-dimethylformamideMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	3.811 ug/mL formulationPASS	<= 880ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for N, N-dimethylformamide Limit of detection 0.5 ug/mL formulation Limit of quantitation 1.5 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
EthanolMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	37.858 ug/mL formulationPASS	<= 5000ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Ethanol Limit of detection 1 ug/mL formulation Limit of quantitation 3 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
AcetoneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	12.51 ug/mL formulationPASS	<= 5000ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Acetone Limit of detection 0.5 ug/mL formulation Limit of quantitation 1.5 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
Ethyl acetateMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	9.308 ug/mL formulationPASS	<= 5000ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Ethyl acetate Limit of detection 0.5 ug/mL formulation Limit of quantitation 1.5 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
TolueneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	1.893 ug/mL formulationPASS	<= 890ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Toluene Limit of detection 0.1 ug/mL formulation Limit of quantitation 0.3 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
n-HexaneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	1.117 ug/mL formulationPASS	<= 290ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for n-Hexane Limit of detection 0.1 ug/mL formulation Limit of quantitation 0.3 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
BenzeneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	0.084 ug/mL formulationPASS	<= 2ug/mL formulation	M-T08-DEFAULT
Supporting analytical detail for Benzene Limit of detection 0.01 ug/mL formulation Limit of quantitation 0.03 ug/mL formulation Sample units 3 finished containers Analytical replicates 2

T09Elemental impurities

Test / endpoint	Result	Acceptance criterion	Method
LeadTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0129 ug/mL formulationPASS	<= 0.5ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Lead Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2 element identity Pb, Cd, As, Hg, Co, V, Ni, Pd, Pt, Rh, Ru and Ir. Intentional cobalt is excluded from the trace-total limit for B12 and MIC.Method and sample context; reference facts are in Identity Reference. element speciation Total elements by ICP-MS; free or non-cobalamin cobalt and unbound copper require separate speciation endpoints.Method and sample context; reference facts are in Identity Reference. digestion method Microwave digestion with HNO3/H2O2; 0.1000 g or 1.000 mL of sample prepared to a final volume of 10.00 mL.Method and sample context; reference facts are in Identity Reference. full element panel The explicit panel is listed in Results; this does not claim that every element in the periodic table was tested.Method and sample context; reference facts are in Identity Reference.
CadmiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0079 ug/mL formulationPASS	<= 0.2ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Cadmium Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
ArsenicTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.019 ug/mL formulationPASS	<= 0.5ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Arsenic Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
MercuryTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0065 ug/mL formulationPASS	<= 0.1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Mercury Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
CobaltTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0207 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Cobalt Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
VanadiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0222 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Vanadium Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
NickelTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0383 ug/mL formulationPASS	<= 2ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Nickel Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
PalladiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0101 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Palladium Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
PlatinumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0081 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Platinum Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
RhodiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0065 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Rhodium Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
RutheniumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0083 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Ruthenium Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2
IridiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0057 ug/mL formulationPASS	<= 1ug/mL formulation	M-T09-DEFAULT
Supporting analytical detail for Iridium Limit of detection 0.0005 ug/mL formulation Limit of quantitation 0.002 ug/mL formulation Sample units 3 finished containers Analytical replicates 2

T13pH and analytical solution

Test / endpoint	Result	Acceptance criterion	Method
pH of native liquidAs supplied,25.0C; buffer-solution compatibility is not the pH of dry material	5.51 pHPASS	4.8 to 6.2pH	M-T13-DEFAULT
Supporting analytical detail for pH of native liquid Sample units 3 finished containers Analytical replicates 2 measurement temperature 25.0 C.Method and sample context; reference facts are in Identity Reference. as supplied or prepared solution Native liquidMethod and sample context; reference facts are in Identity Reference. test solution concentration As labeled liquid concentrationsMethod and sample context; reference facts are in Identity Reference. solvent or vehicle Native water vehicle.Method and sample context; reference facts are in Identity Reference. instrument calibration Three-point calibration at pH 4.01, 7.00 and 10.01; acetic acid uses pH 1.68, 4.01 and 7.00. calibration.Method and sample context; reference facts are in Identity Reference.

T14Excipients and preservatives

Test / endpoint	Result	Acceptance criterion	Method
Vehicle and preservative compositionExplicit formulation choice, not a statement about actual catalog formulation	Water q.s. declared volume; no added preservativePASS	Conforms to the specified acceptance criterion	M-T14-DEFAULT
Supporting analytical detail for Vehicle and preservative composition Sample units 3 finished containers Analytical replicates 2 excipient or preservative identity Benzyl alcohol at 0.90% w/v for bacteriostatic water; 5 mg trehalose per dry vial; MCC q.s. to a 200 mg moist net fill plus a 60 mg HPMC shell for capsules; water q.s. for other liquids.Method and sample context; reference facts are in Identity Reference. concentration basis Explicit mg/unit or mg/mL; w/v means grams per 100 mL.Method and sample context; reference facts are in Identity Reference. quantitative reference standard Separate excipient or preservative standard; the active-component standard is not interchangeable.Method and sample context; reference facts are in Identity Reference.

T21Appearance and physical inspection

Test / endpoint	Result	Acceptance criterion	Method
AppearanceThree containers under diffuse white illumination	colorless; clear solutionPASS	Conforms to the specified acceptance criterion	M-T21-DEFAULT
Supporting analytical detail for Appearance Sample units 3 finished containers Analytical replicates 2 received material form aqueous liquid in vial observed color colorless observed clarity Clear where an aqueous molecular solution is specified. Lemon Bottle is an intentional yellow opalescent dispersion. Clarity is not applicable to dry material.Method and sample context; reference facts are in Identity Reference. visible foreign material None observed in three inspected units.Method and sample context; reference facts are in Identity Reference.
Visible foreign matterVisual observation only; subvisible particles reported separately	None observed in 3 inspected unitsPASS	Conforms to the specified acceptance criterion	M-T21-DEFAULT
Supporting analytical detail for Visible foreign matter Sample units 3 finished containers Analytical replicates 2

T10Sterility test

Test / endpoint	Result	Acceptance criterion	Method
Sterility: FTMFTM30-35C; tested units only; growth-promotion/suitability controls conform	No growth at 14 days in all 20 unitsPASS	Conforms to the specified acceptance criterion	M-T10-DEFAULT
Supporting analytical detail for Sterility: FTM Sample units 20 finished containers Analytical replicates 1 media identifiers FTM-001 and SCDM-001.Method and sample context; reference facts are in Identity Reference. sample amount per medium Half of each prepared full unit per medium. The Lemon Bottle dispersion uses neutralized direct inoculation with matrix suitability.Method and sample context; reference facts are in Identity Reference. units per medium 20 finished units contribute to each medium; sample units are not reused for destructive chemical testing.Method and sample context; reference facts are in Identity Reference. incubation duration 14 days.Method and sample context; reference facts are in Identity Reference. incubation temperature FTM: 30-35 C; SCDM: 20-25 C.Method and sample context; reference facts are in Identity Reference. growth promotion control Reference challenges at <=100 CFU show growth; organism and medium suitability controls are documented as .Method and sample context; reference facts are in Identity Reference. negative control No growth in the medium and process negative controls over 14 days.Method and sample context; reference facts are in Identity Reference. product suitability Growth is recovered in the product-spiked method control. This is and is not inferred from a no-growth sample.Method and sample context; reference facts are in Identity Reference. neutralization or membrane filtration Membrane filtration and rinsing; the intentional colloidal dispersion uses neutralized direct inoculation.Method and sample context; reference facts are in Identity Reference. observed growth by medium No growth in FTM or SCDM on days 3, 7 and 14 for each of the 20 units.Method and sample context; reference facts are in Identity Reference. sampling plan and scope Selected units only; this is not a sterility assurance level or proof that all units in the lot are sterile.Method and sample context; reference facts are in Identity Reference.
Sterility: SCDMSCDM20-25C; tested units only; no sterility assurance level assigned	No growth at 14 days in all 20 unitsPASS	Conforms to the specified acceptance criterion	M-T10-DEFAULT
Supporting analytical detail for Sterility: SCDM Sample units 20 finished containers Analytical replicates 1

T11Bacterial endotoxins

Test / endpoint	Result	Acceptance criterion	Method
Bacterial endotoxinsSample reporting limit after1:5 dilution; threshold is and not based on administration route/dose	<0.025 EU/mLPASS	<= 0.1EU/mL	M-T11-DEFAULT
Supporting analytical detail for Bacterial endotoxins Limit of detection 0.01 EU/mL Limit of quantitation 0.025 EU/mL Sample units 3 finished containers Analytical replicates 2 assay reagent and technique Recombinant factor C fluorometric assay.Method and sample context; reference facts are in Identity Reference. reagent lot RFC-001Method and sample context; reference facts are in Identity Reference. assay sensitivity Assay LOQ: 0.005 EU/mL. After a 1:5 dilution, the reporting limit is 0.025 in the native unit: EU/mg, EU/mL or EU/vial.Method and sample context; reference facts are in Identity Reference. sample extraction 1 mg active equivalent/mL for dry products labeled by mass; one vial/mL for IU-labeled products; native liquid for solutions.Method and sample context; reference facts are in Identity Reference. dilution factor 5 Explicit context; see valueMethod and sample context; reference facts are in Identity Reference. maximum valid dilution if used 20 Explicit context; see valueMethod and sample context; reference facts are in Identity Reference. positive product control recovery 99.5%, 100.5% and 101.5%; acceptance range: 50-200%.Method and sample context; reference facts are in Identity Reference. interference or inhibition assessment The positive product control shows no inhibition or enhancement in the matrix; dilution is within the MVD.Method and sample context; reference facts are in Identity Reference. standard endotoxin reference RSE-001: activity-traceable standard.Method and sample context; reference facts are in Identity Reference. unit conversion basis Native result = assay concentration in EU/mL x 5 / native equivalent concentration. Censored values remain censored.Method and sample context; reference facts are in Identity Reference.

T12Microbial enumeration

Test / endpoint	Result	Acceptance criterion	Method
TAMCZero colonies observed from1g or1 mL equivalent filter; report <1, not exact absence	<1 CFU/mLPASS	<= 100CFU/mL	M-T12-DEFAULT
Supporting analytical detail for TAMC Limit of detection 1 CFU/mL Limit of quantitation 1 CFU/mL Sample units 3 finished containers Analytical replicates 2 TAMC individual count 0 and 0 colonies from separate filters representing 1 g or 1 mL each; report <1 CFU/g or <1 CFU/mL.Method and sample context; reference facts are in Identity Reference. TYMC individual count 0 and 0 colonies from separate filters representing 1 g or 1 mL each; report <1 CFU/g or <1 CFU/mL.Method and sample context; reference facts are in Identity Reference. specified organism identity E. coli, S. aureus, P. aeruginosa, Salmonella species and C. albicans.Method and sample context; reference facts are in Identity Reference. organism presence absence Not detected in 1 g or 1 mL per organism; positive and negative enrichment controls conform to the assigned reference.Method and sample context; reference facts are in Identity Reference. sample amount tested Separate 1 g or 1 mL equivalents for each enumeration filter and organism assay; pooled dry units are documented.Method and sample context; reference facts are in Identity Reference. media and incubation TAMC: SCD agar at 30-35 C for 5 days. TYMC: Sabouraud agar at 20-25 C for 7 days. Specified organisms use organism-specific enrichment and confirmation.Method and sample context; reference facts are in Identity Reference. method suitability spike recoveries: 96% and 97%; blank: 0 colonies.Method and sample context; reference facts are in Identity Reference. neutralization Matrix-specific dilution or neutralization; inhibitory benzyl alcohol or peptide activity requires demonstrated recovery.Method and sample context; reference facts are in Identity Reference. enumeration limit 1 CFU/g for dry material or 1 CFU/mL for liquid, based on one equivalent sample unit filtered; no exact-zero burden is claimed.Method and sample context; reference facts are in Identity Reference.
TYMCZero colonies observed from1g or1 mL equivalent filter; report <1, not exact absence	<1 CFU/mLPASS	<= 10CFU/mL	M-T12-DEFAULT
Supporting analytical detail for TYMC Limit of detection 1 CFU/mL Limit of quantitation 1 CFU/mL Sample units 3 finished containers Analytical replicates 2
Escherichia coliSpecified-organism enrichment in explicit1g/1 mL scope; not a universal pharmacopeial panel	Not detected in 1 mLPASS	Conforms to the specified acceptance criterion	M-T12-DEFAULT
Supporting analytical detail for Escherichia coli Sample units 1 finished containers Analytical replicates 1
Staphylococcus aureusSpecified-organism enrichment in explicit1g/1 mL scope; not a universal pharmacopeial panel	Not detected in 1 mLPASS	Conforms to the specified acceptance criterion	M-T12-DEFAULT
Supporting analytical detail for Staphylococcus aureus Sample units 1 finished containers Analytical replicates 1
Pseudomonas aeruginosaSpecified-organism enrichment in explicit1g/1 mL scope; not a universal pharmacopeial panel	Not detected in 1 mLPASS	Conforms to the specified acceptance criterion	M-T12-DEFAULT
Supporting analytical detail for Pseudomonas aeruginosa Sample units 1 finished containers Analytical replicates 1
Salmonella speciesSpecified-organism enrichment in explicit1g/1 mL scope; not a universal pharmacopeial panel	Not detected in 1 mLPASS	Conforms to the specified acceptance criterion	M-T12-DEFAULT
Supporting analytical detail for Salmonella species Sample units 1 finished containers Analytical replicates 1
Candida albicansSpecified-organism enrichment in explicit1g/1 mL scope; not a universal pharmacopeial panel	Not detected in 1 mLPASS	Conforms to the specified acceptance criterion	M-T12-DEFAULT
Supporting analytical detail for Candida albicans Sample units 1 finished containers Analytical replicates 1

T16Biological activity

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.N/A — justified	Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.	M-T16-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 finished containers Analytical replicates 0 biological endpoint Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. assay system Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. reference standard and activity Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. activity unit definition Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. concentration response range Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. curve fit Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. controls Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. biological replicates Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. confidence interval Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope. mass activity relationship if validated Not applicable — No qualified, reference-traceable potency endpoint is established for this selected identity. Identity/content data cannot justify an invented biological potency value; exploratory biological activity would require a separately defined assay.Outside the defined test scope.

T17Protein and conjugate characterization

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.N/A — justified	Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.	M-T17-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 finished containers Analytical replicates 0 full construct sequence Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. expression system Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. PEG architecture and distribution Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. PEG attachment site Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. conjugated to free fraction Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. glycosylation Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. oligomer or chain state Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. reduction or deglycosylation Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. aggregate fraction Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. gel conditions and markers Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. identity antibody or mapping Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope. intact mass distribution Not applicable — No recombinant protein, polymer conjugate or complex mixture for this material. Defined synthetic peptide identity is characterized under T01; GHK copper speciation, when relevant, is explicit.Outside the defined test scope.

T18Process impurities

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.N/A — justified	Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.	M-T18-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 finished containers Analytical replicates 0 expression or tissue source Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.Outside the defined test scope. process impurity identity Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.Outside the defined test scope. HCP assay coverage Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.Outside the defined test scope. DNA extraction recovery Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.Outside the defined test scope. process stage Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.Outside the defined test scope. assay control scope Not applicable — chemical synthesis without cell/tissue manufacturing inputs; HCP, host DNA and Protein A are not relevant. Chemical process impurities are covered under T05/T08/T09.Outside the defined test scope.

T19Particles and container closure

Test / endpoint	Result	Acceptance criterion	Method
Subvisible particles >= 10umAs-supplied liquid or entire dry vial dissolved to stated analytical volume; limits, no injectable compliance claim	21 particles/containerPASS	<= 6000particles/container	M-T19-DEFAULT
Supporting analytical detail for Subvisible particles >= 10um Sample units 3 finished containers Analytical replicates 1 container closure configuration Type I borosilicate glass with a bromobutyl stopper and crimp seal; package.Method and sample context; reference facts are in Identity Reference. particle size bin >=10 um and >=25 um; not applicable to intentional dispersions or capsules.Method and sample context; reference facts are in Identity Reference. inspection volume 10 mL analytical volume; normalization to the entire containerMethod and sample context; reference facts are in Identity Reference. closure integrity method Vacuum decay with a limit of 0.20 kPa over 60 s; capsule bottles use seal-condition inspection.Method and sample context; reference facts are in Identity Reference. leakage detection limit 5 um artificial positive-leak control; not a universal maximum allowable leakage limit.Method and sample context; reference facts are in Identity Reference. packaging sample count 10 Explicit context; see valueMethod and sample context; reference facts are in Identity Reference.
Subvisible particles >= 25umAs-supplied liquid or entire dry vial dissolved to stated analytical volume; limits, no injectable compliance claim	2 particles/containerPASS	<= 600particles/container	M-T19-DEFAULT
Supporting analytical detail for Subvisible particles >= 25um Sample units 3 finished containers Analytical replicates 1
Vacuum decay package integritymethod vacuum-decay threshold0.20kPa/60s;5um positive defect control. No universal leakage-to-sterility equivalence.	10/10test closures conform; positive-leak controls detectedPASS	Conforms to the specified acceptance criterion	M-T19-DEFAULT
Supporting analytical detail for Vacuum decay package integrity Sample units 10 finished containers Analytical replicates 1

T20Stability observations

Test / endpoint	Result	Acceptance criterion	Method
Reported 6 month assay retentionReported change relative to the initial assay. This report does not assign a retest date or shelf life.	99.91 % of initial assayPASS	98 to 102% of initial assay	M-T20-DEFAULT
Supporting analytical detail for Reported 6 month assay retention Sample units 3 finished containers Analytical replicates 2 study protocol id STAB-P2703-SIMPLEMethod and sample context; reference facts are in Identity Reference. storage temperature 2-8 C, protected from lightMethod and sample context; reference facts are in Identity Reference. humidity or light Protected from light in a sealed container; no ICH humidity claim.Method and sample context; reference facts are in Identity Reference. container configuration Same container as the initial unit.Method and sample context; reference facts are in Identity Reference. elapsed time Reported months 0, 1, 3 and 6.Method and sample context; reference facts are in Identity Reference. freeze thaw or excursion scope Not modeled; no excursion or freeze-thaw claim is supported.Method and sample context; reference facts are in Identity Reference. retest or expiry rationale six-month review only; actual expiry or retest is not assigned without real stability data.Method and sample context; reference facts are in Identity Reference.
Reported 6 month minimum component puritySeparate endpoint; no shelf-life claim	99.871 % integrated detector areaPASS	99.7 to 100% integrated detector area	M-T20-DEFAULT
Supporting analytical detail for Reported 6 month minimum component purity Sample units 3 finished containers Analytical replicates 2
Dating dispositionReported change relative to the initial assay. This report does not assign a retest date or shelf life.	6 month review point; actual expiry/retest not assignedPASS	Conforms to the specified acceptance criterion	M-T20-DEFAULT
Supporting analytical detail for Dating disposition Sample units 3 finished containers Analytical replicates 2

Method references

How the results are documented

M-T01-DEFAULT: Orthogonal chemical/structural identityLC-HRMS/MS plus sequence/connectivity-sensitive reference comparison
M-T02-HILIC-CAD: Nonchromophoric component chromatographic response purityHILIC with charged aerosol detection
M-T05-DEFAULT: Related substancesStability-indicating LC integration; orthogonal size/charge separation for biologics
M-T03-DEFAULT: Calibrated material contentIndependent quantitative LC/CAD, protein assay or bioactivity calibration for IU
M-T04-DEFAULT: Component-resolved blend assaySeparate calibrated selective assay for every declared component
M-T15-DEFAULT: Individual-unit uniformityTen separate unit preparations and fill measurements
M-T06-DEFAULT: WaterCoulometric Karl Fischer
M-T07-DEFAULT: Counterion compositionIon chromatography and stoichiometric accounting
M-T08-DEFAULT: Residual solvent panelheadspace GC-MS
M-T09-DEFAULT: Elemental impurity panelICP-MS
M-T13-DEFAULT: pH and solution stateCalibrated potentiometry
M-T14-DEFAULT: Excipients/preservativesComponent-specific quantitative LC/CAD or formulation identity
M-T21-DEFAULT: AppearanceControlled visual examination
M-T10-DEFAULT: Sterility observations in two media with matrix-specific preparationMembrane filtration/rinsing or neutralized direct inoculation for Lemon dispersion
M-T11-DEFAULT: Bacterial endotoxinsRecombinant factor C fluorometric assay
M-T12-DEFAULT: Microbial enumeration/organismsMembrane filtration enumeration and enrichment
M-T16-DEFAULT: Functional biological activityReference-relative concentration-response assay
M-T17-DEFAULT: Protein/conjugate characterizationSEC-MALS, CE-SDS, peptide mapping, glycan/PEG profiling
M-T18-DEFAULT: Biological process impurity panelHost/process-specific ELISA and qPCR
M-T01-BLEND-SELECTIVE-HRMS: Component-specific exact-ion identity for the declared blendComponent-selective LC-HRMS with independently defined molecular ions
M-T04-BLEND-SELECTIVE-IDENTITY: Identity definition for each selectively assayed blend componentComponent-selective reference comparison with orthogonal identity controls
M-T07-CHLORIDE-IC: Intentional chloride content and choline/chloride molar consistencyIndependent chloride ion chromatography with separate choline-cation assay
M-T19-DEFAULT: Particles and package integrityLight obscuration plus vacuum decay
M-T20-DEFAULT: Stability observationTime-zero/1/3/6-month trend

Apex Laboratory issues this certificate. Results apply to the stated configuration and lot. Browse all certificates.