Certificate of analysis · Apex Laboratory

Dihexa 10 mg (60pcs)

APX-2026-0404-D

COA issue date: Apr 4, 2026
Report ID: APX-COA-2026-0404-D
Issuing laboratory: Apex Laboratory
Configuration: Dihexa 10 mg (60pcs)
Authorized by: K. Norwood
Documented endpoints: 59 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 referenceDihexa: N-hexanoyl-L-Tyr-L-Ile-NH-(CH2)5-C(O)NH2; TyrS and Ile2S,3S. 60 capsules with 10.00 mg anhydrous Dihexa equivalent each.	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 capsules Analytical replicates 2 identified structure or sequence Dihexa: N-hexanoyl-L-Tyr-L-Ile-NH-(CH2)5-C(O)NH2; TyrS and Ile2S,3S. 60 capsules with 10.00 mg anhydrous Dihexa equivalent each. neutral average mass 504.7 Da or explicit reason neutral monoisotopic mass 504.33117052 DaReference, not measured neutral mass observed mz 505.337923 m/z charge state 1 integer adduct [M+1H]^1+ 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-2724; 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 capsules Analytical replicates 2
Dihexa 10 mg (60pcs) HRMS ion mass error[M+1H]^1+; reference monoisotopic M=504.33117052 Da; molecule excludes associated salt/solvate	-1.0369 ppmPASS	-5 to 5ppm	M-T01-DEFAULT
Supporting analytical detail for Dihexa 10 mg (60pcs) HRMS ion mass error Sample units 3 capsules Analytical replicates 2

T02Chromatographic purity

Test / endpoint	Result	Acceptance criterion	Method
Dihexa 10 mg (60pcs) 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-RP-UPLC-DAD
Supporting analytical detail for Dihexa 10 mg (60pcs) chromatographic purity Sample units 3 capsules 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 11.764 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 9993800 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
Dihexa 10 mg (60pcs) 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 Dihexa 10 mg (60pcs) Unknown U1 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 capsules 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.
Dihexa 10 mg (60pcs) 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 Dihexa 10 mg (60pcs) Unknown U2 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 capsules Analytical replicates 2
Dihexa 10 mg (60pcs) 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 Dihexa 10 mg (60pcs) Unknown U3 Limit of detection 0.002 % integrated detector area Limit of quantitation 0.005 % integrated detector area Sample units 3 capsules Analytical replicates 2
Dihexa 10 mg (60pcs) 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 Dihexa 10 mg (60pcs) total related peaks Sample units 3 capsules Analytical replicates 2

T03Active content and assay

Test / endpoint	Result	Acceptance criterion	Method
Dihexa 10 mg (60pcs) active contentAssigned component material basis; excludes vehicle/excipient/water; salt basis explicitly in identity specification	10.0085 mg/capsulePASS	9.8 to 10.2mg/capsule	M-T03-DEFAULT
Supporting analytical detail for Dihexa 10 mg (60pcs) active content Sample units 3 capsules Analytical replicates 2 quantitative reference standard RS-2724; 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 200.000000 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.
Dihexa 10 mg (60pcs) label claim assayIndependent calibrated amount / nominal amount x 100; not chromatographic area purity	100.085 % label claimPASS	98 to 102% label claim	M-T03-DEFAULT
Supporting analytical detail for Dihexa 10 mg (60pcs) label claim assay Sample units 3 capsules Analytical replicates 2

T15Unit uniformity

Test / endpoint	Result	Acceptance criterion	Method
Dihexa 10 mg (60pcs) individual-unit meanspecified sample/form only	100.085 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for Dihexa 10 mg (60pcs) individual-unit mean Sample units 10 capsules Analytical replicates 1 individual fill mass 200.000000 mg nominal wet fill; capsule shell excludedMethod and sample context; reference facts are in Identity Reference. physical unit count 60 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.
Dihexa 10 mg (60pcs) 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 Dihexa 10 mg (60pcs) acceptance value (n=10) Sample units 10 capsules Analytical replicates 1
Dihexa 10 mg (60pcs) individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3521 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for Dihexa 10 mg (60pcs) individual-unit RSD Sample units 10 capsules Analytical replicates 1
Physical capsule countthree-bottle count inspection	60 capsules/bottlePASS	60 to 60capsules/bottle	M-T15-DEFAULT
Supporting analytical detail for Physical capsule count Sample units 3 capsules 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 capsules 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	0.78 % w/w finished fillPASS	<= 2% w/w finished fill	M-T06-KF
Supporting analytical detail for Residual water Sample units 3 capsules 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 1.007861318282604 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
Applicability decisionspecified sample/form only	Not applicable — No fixed counterion salt is assigned in this formulation; vehicle ions and intentional metal complexes are treated by their component specifications.N/A — justified	Not applicable — No fixed counterion salt is assigned in this formulation; vehicle ions and intentional metal complexes are treated by their component specifications.	M-T07-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 capsules Analytical replicates 0 counterion identity Not applicable — No fixed counterion salt is assigned in this formulation; vehicle ions and intentional metal complexes are treated by their component specifications.Outside the defined test scope. counterion molar ratio Not applicable — No fixed counterion salt is assigned in this formulation; vehicle ions and intentional metal complexes are treated by their component specifications.Outside the defined test scope. salt or solvate specification Not applicable — No fixed counterion salt is assigned in this formulation; vehicle ions and intentional metal complexes are treated by their component specifications.Outside the defined test scope.

T08Residual solvents

Test / endpoint	Result	Acceptance criterion	Method
MethanolMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	23.096 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 capsules 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.	7.699 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 capsules Analytical replicates 2
DichloromethaneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	3.924 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 capsules Analytical replicates 2
N, N-dimethylformamideMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	3.899 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 capsules Analytical replicates 2
EthanolMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	40.024 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 capsules Analytical replicates 2
AcetoneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	11.956 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 capsules Analytical replicates 2
Ethyl acetateMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	9.807 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 capsules Analytical replicates 2
TolueneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	1.839 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 capsules Analytical replicates 2
n-HexaneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	1.03 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 capsules Analytical replicates 2
BenzeneMaterial-based limit. Liquid numerical limits are listed specification and not ICH Option1 mass ppm.	0.083 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 capsules 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.	0.0123 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 capsules 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.	0.0085 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 capsules Analytical replicates 2
ArsenicTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0174 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 capsules Analytical replicates 2
MercuryTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0055 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 capsules Analytical replicates 2
CobaltTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0201 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 capsules Analytical replicates 2
VanadiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0238 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 capsules Analytical replicates 2
NickelTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0344 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 capsules Analytical replicates 2
PalladiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.01 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 capsules Analytical replicates 2
PlatinumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0083 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 capsules Analytical replicates 2
RhodiumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0073 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 capsules Analytical replicates 2
RutheniumTotal element; no speciation. material-based criterion, not a dose/route-derived safety limit.	0.0082 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 capsules 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 capsules Analytical replicates 2

T13pH and analytical solution

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.N/A — justified	Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.	M-T13-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 capsules Analytical replicates 0 measurement temperature Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.Outside the defined test scope. as supplied or prepared solution Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.Outside the defined test scope. test solution concentration Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.Outside the defined test scope. solvent or vehicle Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.Outside the defined test scope. instrument calibration Not applicable — No validated aqueous solution pH specification for this capsule/poorly aqueous-soluble material. Extraction conditions for identity/assay are separately specified; no pH value is invented for dry powder.Outside the defined test scope.

T14Excipients and preservatives

Test / endpoint	Result	Acceptance criterion	Method
Microcrystalline cellulose contentSeparate excipient-specific assay; not label active	188.591 mg/capsuleRecorded numeric value: 188.59075PASS	179.018 to 197.862mg/capsule	M-T14-DEFAULT
Supporting analytical detail for Microcrystalline cellulose content Sample units 3 capsules 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 intact capsulePASS	Conforms to the specified acceptance criterion	M-T21-DEFAULT
Supporting analytical detail for Appearance Sample units 3 capsules Analytical replicates 2 received material form capsule 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 capsules Analytical replicates 2

T10Sterility test

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.N/A — justified	Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.	M-T10-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 capsules Analytical replicates 0 method and edition Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. media identifiers Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. sample amount per medium Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. units per medium Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. incubation duration Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. incubation temperature Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. growth promotion control Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. negative control Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. product suitability Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. neutralization or membrane filtration Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. observed growth by medium Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope. sampling plan and scope Not applicable — capsules are nonsterile solids. Microbial limits are appropriate; reporting a passing sterility test would imply an unassigned sterile product specification.Outside the defined test scope.

T11Bacterial endotoxins

Test / endpoint	Result	Acceptance criterion	Method
Applicability decisionspecified sample/form only	Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule . Microbial counts cannot be substituted for endotoxin testing.N/A — justified	Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.	M-T11-DEFAULT
Supporting analytical detail for Applicability decision Sample units 0 capsules Analytical replicates 0 assay reagent and technique Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. reagent lot Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. assay sensitivity Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. sample extraction Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. dilution factor Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. maximum valid dilution if used Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. positive product control recovery Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. interference or inhibition assessment Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. standard endotoxin reference Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope. unit conversion basis Not applicable — No endotoxin-controlled intended use or specification is assigned to the nonsterile capsule scenario. Microbial counts cannot be substituted for endotoxin testing.Outside the defined test scope.

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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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
Container closure and visible package conditionNonsterile capsule bottle or intentional dispersion; light-obscuration particulate numbers inappropriate for these matrices	No damage; closure and seal conform in 10 packagesPASS	Conforms to the specified acceptance criterion	M-T19-DEFAULT
Supporting analytical detail for Container closure and visible package condition Sample units 10 capsules Analytical replicates 1 container closure configuration HPMC capsules in a sealed HDPE bottle.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.

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.	99.9101 % of initial assayPASS	98 to 102% of initial assay	M-T20-DEFAULT
Supporting analytical detail for Reported 6 month assay retention Sample units 3 capsules Analytical replicates 2 study protocol id STAB-P2724-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	99.896 % 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 capsules 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 capsules 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-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.