Certificate of analysis · Apex Laboratory

BPC-157 - 10 mg

APX-2026-0725-B

COA issue date: Jul 25, 2026
Report ID: APX-COA-2026-0725-B
Issuing laboratory: Apex Laboratory
Configuration: BPC-157 - 10 mg
Authorized by: K. Norwood
Documented endpoints: 62 across 21 test groups

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

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Analytical record

Results & specifications

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T01Identity and structure

Test / endpoint	Result	Acceptance criterion	Method
Orthogonal identity against specified referenceH-GEPPPGKPADDAGLV-OH,15 residues, all-L except glycine, alpha peptide linkages; acetate-associated form with independently quantified acetate.	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 identified structure or sequence H-GEPPPGKPADDAGLV-OH,15 residues, all-L except glycine, alpha peptide linkages; acetate-associated form with independently quantified acetate. neutral average mass 1419.5 Da or explicit reason neutral monoisotopic mass 1418.70415882 DaReference, not measured neutral mass observed mz 710.360167 m/z charge state 2 integer adduct [M+2H]^2+ 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-2565; 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
BPC-157 HRMS ion mass error[M+2H]^2+; reference monoisotopic M=1418.70415882 Da; molecule excludes associated salt/solvate	1.1418 ppmPASS	-5 to 5ppm	M-T01-DEFAULT
Supporting analytical detail for BPC-157 HRMS ion mass error Sample units 3 finished containers Analytical replicates 2
BPC-157: Pro D fractionResidue-specific target from explicit structure. Mixed D/L ratios are intentional where stated; not total chemical-purity percentage.	0.02 mol% of selected amino acidPASS	0 to 0.1mol% of selected amino acid	M-T01-RESIDUE-CHIRAL-LC
Supporting analytical detail for BPC-157: Pro D fraction Sample units 3 finished containers Analytical replicates 1

T02Chromatographic purity

Test / endpoint	Result	Acceptance criterion	Method
BPC-157 chromatographic puritySingle analyte method scope; intended blend co-components and excipients excluded by analyte-specific selectivity, not denominator manipulation	99.884 % integrated detector areaPASS	99.7 to 100% integrated detector area	M-T02-RP-UPLC-DAD
Supporting analytical detail for BPC-157 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 13.024 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 9988400 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.

T05Related substances and degradants

Test / endpoint	Result	Acceptance criterion	Method
BPC-157 Unknown U1Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.058 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for BPC-157 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.
BPC-157 Unknown U2Same analyte-specific chromatogram as T02; response factor assumed 1.00 for unknowns; area only	0.035 % integrated detector areaPASS	<= 0.1% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for BPC-157 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
BPC-157 Unknown U3Same 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 BPC-157 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
BPC-157 total related peaksSum of U1+U2+U3; purity plus related areas = 100%	0.116 % integrated detector areaPASS	<= 0.3% integrated detector area	M-T05-DEFAULT
Supporting analytical detail for BPC-157 total related peaks Sample units 3 finished containers Analytical replicates 2

T03Active content and assay

Test / endpoint	Result	Acceptance criterion	Method
BPC-157 active contentAssigned component material basis; excludes vehicle/excipient/water; salt basis explicitly in identity specification	10.0178 mg/vialPASS	9.8 to 10.2mg/vial	M-T03-DEFAULT
Supporting analytical detail for BPC-157 active content Sample units 3 finished containers Analytical replicates 2 quantitative reference standard RS-2565; 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 10 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 15.239302 mg total net fill, including moisture and excipientMethod 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.
BPC-157 label claim assayIndependent calibrated amount / nominal amount x 100; not chromatographic area purity	100.178 % label claimPASS	98 to 102% label claim	M-T03-DEFAULT
Supporting analytical detail for BPC-157 label claim assay Sample units 3 finished containers Analytical replicates 2

T15Unit uniformity

Test / endpoint	Result	Acceptance criterion	Method
BPC-157 individual-unit meanspecified sample/form only	100.178 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for BPC-157 individual-unit mean Sample units 10 finished containers Analytical replicates 1 individual fill mass 15.239302 mg nominal wet fill; capsule shell excludedMethod and sample context; reference facts are in Identity Reference. 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.
BPC-157 acceptance value (n=10)AV=abs(M-mean)+2.4 sample SD; target 100%; M=mean within 98.5-101.5	0.8458 % label claimPASS	<= 15% label claim	M-T15-DEFAULT
Supporting analytical detail for BPC-157 acceptance value (n=10) Sample units 10 finished containers Analytical replicates 1
BPC-157 individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3518 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for BPC-157 individual-unit RSD Sample units 10 finished containers Analytical replicates 1

T04Blend composition

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.N/A — justified	Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.	M-T04-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 finished containers Analytical replicates 0 component structure reference Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope. component label amount Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope. component measured amount Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope. component quantitative standard Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope. component response factor Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope. coelution assessment Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope. component ratio basis Not applicable — One declared active or a water/preservative reagent. Preservative is separately quantified under T14; there is no multi-active blend ratio.Outside the defined test scope.

T06Water content

Test / endpoint	Result	Acceptance criterion	Method
Residual waterWater as percentage of total net formulation, not peptide area purity	0.586 % w/w finished fillPASS	<= 2% w/w finished fill	M-T06-KF
Supporting analytical detail for Residual water Sample units 3 finished containers Analytical replicates 2 sample handling Sealed vial transferred to a dry vessel; blank corrected. Pool 0.1000 g of net formulation where needed.Method and sample context; reference facts are in Identity Reference. dry basis correction 1.005894542016215 factorFor mass-fraction reporting only; independent active assay is not blindly multiplied by this factor.

T07Counterions and associated species

Test / endpoint	Result	Acceptance criterion	Method
Acetate content relative to parent active massExplicit process/counterion basis; acetate-associated material. No fixed stoichiometric salt is asserted; acidic peptides may contain residual process acetate rather than a counterion.	1.5 % acetate/parent massPASS	0.5 to 3% acetate/parent mass	M-T07-DEFAULT
Supporting analytical detail for Acetate content relative to parent active mass 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. counterion molar ratio 0.3606208928934354 mol acetate/mol parent 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.

T08Residual solvents

Test / endpoint	Result	Acceptance criterion	Method
MethanolMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	19.574 ug/g finished fillPASS	<= 3000ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Methanol Limit of detection 1 ug/g finished fill Limit of quantitation 3 ug/g finished fill 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.	7.581 ug/g finished fillPASS	<= 410ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Acetonitrile Limit of detection 0.3 ug/g finished fill Limit of quantitation 1 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
DichloromethaneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	3.493 ug/g finished fillPASS	<= 600ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Dichloromethane Limit of detection 0.2 ug/g finished fill Limit of quantitation 0.6 ug/g finished fill 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.	3.933 ug/g finished fillPASS	<= 880ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for N, N-dimethylformamide Limit of detection 0.5 ug/g finished fill Limit of quantitation 1.5 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
EthanolMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	38.062 ug/g finished fillPASS	<= 5000ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Ethanol Limit of detection 1 ug/g finished fill Limit of quantitation 3 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
AcetoneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	11.329 ug/g finished fillPASS	<= 5000ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Acetone Limit of detection 0.5 ug/g finished fill Limit of quantitation 1.5 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
Ethyl acetateMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	9.732 ug/g finished fillPASS	<= 5000ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Ethyl acetate Limit of detection 0.5 ug/g finished fill Limit of quantitation 1.5 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
TolueneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	1.761 ug/g finished fillPASS	<= 890ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Toluene Limit of detection 0.1 ug/g finished fill Limit of quantitation 0.3 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
n-HexaneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	1.007 ug/g finished fillPASS	<= 290ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for n-Hexane Limit of detection 0.1 ug/g finished fill Limit of quantitation 0.3 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
BenzeneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	0.081 ug/g finished fillPASS	<= 2ug/g finished fill	M-T08-DEFAULT
Supporting analytical detail for Benzene Limit of detection 0.01 ug/g finished fill Limit of quantitation 0.03 ug/g finished fill 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.	0.0113 ug/g finished fillPASS	<= 0.5ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Lead Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill 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.	0.0086 ug/g finished fillPASS	<= 0.2ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Cadmium Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
ArsenicTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0164 ug/g finished fillPASS	<= 0.5ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Arsenic Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
MercuryTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0061 ug/g finished fillPASS	<= 0.1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Mercury Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
CobaltTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0229 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Cobalt Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
VanadiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0257 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Vanadium Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
NickelTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0377 ug/g finished fillPASS	<= 2ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Nickel Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
PalladiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0111 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Palladium Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
PlatinumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.009 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Platinum Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
RhodiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0068 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Rhodium Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
RutheniumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0099 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Ruthenium Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2
IridiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0063 ug/g finished fillPASS	<= 1ug/g finished fill	M-T09-DEFAULT
Supporting analytical detail for Iridium Limit of detection 0.0005 ug/g finished fill Limit of quantitation 0.002 ug/g finished fill Sample units 3 finished containers Analytical replicates 2

T13pH and analytical solution

Test / endpoint	Result	Acceptance criterion	Method
pH of specified buffered analytical solution1.000 mg active/mL in 25mM acetate buffer, pH4.80,25.0C; buffer-solution compatibility is not the pH of dry material	4.83 pHPASS	4.1 to 5.5pH	M-T13-DEFAULT
Supporting analytical detail for pH of specified buffered analytical solution 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 Prepared buffered analytical solution; not the pH of dry powder.Method and sample context; reference facts are in Identity Reference. test solution concentration 1.000 mg active/mL.Method and sample context; reference facts are in Identity Reference. solvent or vehicle 10 mM MES at pH 6.0 for GHK-containing material; otherwise 25 mM acetate at pH 4.8.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
Trehalose contentSeparate excipient-specific assay; not label active	5.004 mg/vialPASS	4.75 to 5.25mg/vial	M-T14-DEFAULT
Supporting analytical detail for Trehalose content 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	white to off-white; uniform lyophilized cakePASS	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 lyophilized solid in vial observed color white to off-white 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/mg active-equivalentPASS	<= 0.1EU/mg active-equivalent	M-T11-DEFAULT
Supporting analytical detail for Bacterial endotoxins Limit of detection 0.01 EU/mg active-equivalent Limit of quantitation 0.025 EU/mg active-equivalent 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/g finished fillPASS	<= 100CFU/g finished fill	M-T12-DEFAULT
Supporting analytical detail for TAMC Limit of detection 1 CFU/g finished fill Limit of quantitation 1 CFU/g finished fill 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/g finished fillPASS	<= 10CFU/g finished fill	M-T12-DEFAULT
Supporting analytical detail for TYMC Limit of detection 1 CFU/g finished fill Limit of quantitation 1 CFU/g finished fill 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 1gPASS	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 1gPASS	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 1gPASS	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 1gPASS	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 1gPASS	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 1 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.	99.9102 % 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-P2565-V2581Method and sample context; reference facts are in Identity Reference. storage temperature -20 +/-5 C, protected from light; sealed dry vialMethod 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	99.842 % 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-RP-UPLC-DAD: Component-specific reversed-phase chromatographic response purityRP-UPLC with diode-array 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-T15-DEFAULT: Individual-unit uniformityTen separate unit preparations and fill measurements
M-T04-DEFAULT: Component-resolved blend assaySeparate calibrated selective assay for every declared component
M-T06-KF: Residual formulation water on a defined mass basisCoulometric Karl Fischer with oven transfer
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-RESIDUE-CHIRAL-LC: Diagnostic amino-acid absolute-configuration/composition checkMarfey-type diastereomeric derivatization LC-MS with authentic L/D references
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.