Certificate of analysis · Apex Laboratory

HMG 75iu

APX-2026-0408-H

COA issue date: Apr 8, 2026
Report ID: APX-COA-2026-0408-H
Issuing laboratory: Apex Laboratory
Configuration: HMG 75iu
Authorized by: K. Norwood
Documented endpoints: 71 across 21 test groups

Download PDF Preview

View HMG 75iu product

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

Preview report pages

Analytical record

Results & specifications

Download result tables

T01Identity and structure

Test / endpoint	Result	Acceptance criterion	Method
Orthogonal identity against specified reference	Conforms to the assigned reference; see identity basisPASS	Conforms to the specified acceptance criterion	M-T01-DEFAULT
Supporting analytical detail for Orthogonal identity against specified reference Sample units 3 finished containers Analytical replicates 2 neutral average mass Not assigned: construct/distribution or no supported unique species neutral monoisotopic mass Not assigned — see component-specific HRMS records; a reference mass is not a measured neutral massMethod and sample context; reference facts are in Identity Reference. observed mz Not assigned — heterogeneous construct or no defined ion; orthogonal identity documented insteadMethod and sample context; reference facts are in Identity Reference. mass tolerance +/-5 ppm for an explicitly defined monoisotopic ion; not 5 Da.Method and sample context; reference facts are in Identity Reference. reduced deglycosylated or intact Intact specified parent for defined compounds; glycoproteins and PEG retain the specified population heterogeneity. No single exact intact glycoprotein mass is invented.Method and sample context; reference facts are in Identity Reference. stereochemistry method Component-specific chiral amino acid analysis or orthogonal structure comparison, where applicable; HRMS cannot distinguish stereoisomers.Method and sample context; reference facts are in Identity Reference. identity standard traceability RS-2630; 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

T02Chromatographic purity

Test / endpoint	Result	Acceptance criterion	Method
Multipeak fingerprint similarity to defined referenceFingerprint similarity, not chemical purity percentage	0.9995 similarity (0-1)PASS	>= 0.995similarity (0-1)	M-T02-DEFAULT
Supporting analytical detail for Multipeak fingerprint similarity to defined reference 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. 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. 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
New unexplained chromatographic signal outside defined fingerprintAggregate non-reference signal; not mass fraction or component purity	0.035 % total fingerprint responsePASS	<= 0.1% total fingerprint response	M-T05-DEFAULT
Supporting analytical detail for New unexplained chromatographic signal outside defined fingerprint Limit of detection 0.002 % total fingerprint response Limit of quantitation 0.005 % total fingerprint response 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.

T03Active content and assay

Test / endpoint	Result	Acceptance criterion	Method
FSH activity per vialAssigned against a activity reference; IU is not converted to milligrams	75.072 IU/vialPASS	71.25 to 78.75IU/vial	M-T03-BIOACTIVITY
Supporting analytical detail for FSH activity per vial Sample units 3 finished containers Analytical replicates 2 quantitative reference standard RS-2630; 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. dilution factor See analyte-specific factors; no arbitrary common dilution imposed on all strengthsMethod and sample context; reference facts are in Identity Reference. water correction Water excluded by calibration to active-equivalent standard; moisture separately measured. No area-purity times gross-fill calculation.Method and sample context; reference facts are in Identity Reference. counterion correction Parent-equivalent content unless explicit iodide/choline chloride salt or GHK complex basis. Counterion/metal composition separately quantified.Method and sample context; reference facts are in Identity Reference. gross fill mass No mass is inferred from IU or liquid volume; separate formulation fill quantity appliesMethod and sample context; reference facts are in Identity Reference. active material basis mg per capsule or vial on the explicitly specified material basis; IU on the assigned biological-activity basis. Package count and package total are reported separately.Method and sample context; reference facts are in Identity Reference.
LH activity per vialAssigned against a activity reference; IU is not converted to milligrams	75.13 IU/vialPASS	71.25 to 78.75IU/vial	M-T03-BIOACTIVITY
Supporting analytical detail for LH activity per vial Sample units 3 finished containers Analytical replicates 2

T04Blend composition

Test / endpoint	Result	Acceptance criterion	Method
FSH activity component identity	Conforms to specified component identityPASS	Conforms to the specified acceptance criterion	M-T04-DEFAULT
Supporting analytical detail for FSH activity component identity Sample units 3 finished containers Analytical replicates 2 component label amount FSH activity=75 IU; LH activity=75 IUMethod and sample context; reference facts are in Identity Reference. component measured amount FSH activity=75.072000 IU; LH activity=75.130000 IUMethod and sample context; reference facts are in Identity Reference. component quantitative standard Separate RS component standards; content and response are assigned independently for each component.Method and sample context; reference facts are in Identity Reference. coelution assessment Selective component extraction and separation are assumed verified in the placebo and spiked blend; a whole-blend peak is not used for every analyte.Method and sample context; reference facts are in Identity Reference. component ratio basis Mass ratio applies only to components labeled in mg. FSH and LH IU are separate bioactivity units and are not added to milligrams.Method and sample context; reference facts are in Identity Reference.
FSH activity component contentSame independent component assay as T03, not a second independent test	75.072 IU/vialPASS	71.25 to 78.75IU/vial	M-T04-DEFAULT
Supporting analytical detail for FSH activity component content Sample units 3 finished containers Analytical replicates 2
LH activity component identity	Conforms to specified component identityPASS	Conforms to the specified acceptance criterion	M-T04-DEFAULT
Supporting analytical detail for LH activity component identity Sample units 3 finished containers Analytical replicates 2
LH activity component contentSame independent component assay as T03, not a second independent test	75.13 IU/vialPASS	71.25 to 78.75IU/vial	M-T04-DEFAULT
Supporting analytical detail for LH activity component content Sample units 3 finished containers Analytical replicates 2

T15Unit uniformity

Test / endpoint	Result	Acceptance criterion	Method
FSH activity individual-unit meanspecified sample/form only	100.096 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for FSH activity individual-unit mean Sample units 10 finished containers Analytical replicates 1 physical unit count 1 Explicit context; see valueMethod and sample context; reference facts are in Identity Reference. unit statistical summary Mean, sample SD, RSD, M, k and AV are calculated from 10 individual observations; AV for a multidose liquid is descriptive only.Method and sample context; reference facts are in Identity Reference. sampling plan 10 independent units per configuration, with component assays from the same units; separate from the three-unit composite assay.Method and sample context; reference facts are in Identity Reference.
FSH activity 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 FSH activity acceptance value (n=10) Sample units 10 finished containers Analytical replicates 1
FSH activity individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3521 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for FSH activity individual-unit RSD Sample units 10 finished containers Analytical replicates 1
LH activity individual-unit meanspecified sample/form only	100.173 % label claimPASS	98 to 102% label claim	M-T15-DEFAULT
Supporting analytical detail for LH activity individual-unit mean Sample units 10 finished containers Analytical replicates 1
LH activity 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 LH activity acceptance value (n=10) Sample units 10 finished containers Analytical replicates 1
LH activity individual-unit RSDPrecision criterion for the listed specification, independently of AV	0.3518 %PASS	<= 2%	M-T15-DEFAULT
Supporting analytical detail for LH activity individual-unit RSD Sample units 10 finished containers Analytical replicates 1

T06Water content

Test / endpoint	Result	Acceptance criterion	Method
Residual waterWater as percentage of total net formulation, not peptide area purity	0.547 % 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 1.005500085467507 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 finished containers 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.	20.085 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.	8.75 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.	3.366 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.	4.209 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.	35.033 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.	12.922 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.	9.07 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.	1.621 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.	1.159 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.	0.085 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.	0.0074 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.	0.0185 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.	0.0056 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.	0.021 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.	0.024 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.	0.0382 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.	0.0103 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.	0.0091 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.	0.0071 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.	0.0084 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.	0.0056 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	4.79 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 excipientExplicit stabilizer amount; biological protein mass remains independent of IU	5.004 mg/vialPASS	4.75 to 5.25mg/vial	M-T14-DEFAULT
Supporting analytical detail for Trehalose excipient 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/vialPASS	<= 0.1EU/vial	M-T11-DEFAULT
Supporting analytical detail for Bacterial endotoxins Limit of detection 0.01 EU/vial Limit of quantitation 0.025 EU/vial 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
FSHR relative potencyRelative to the specified reference response; activity units and mass units are evaluated separately. Method validation is not asserted by this report.	100.096 % reference response potencyPASS	90 to 110% reference response potency	M-T16-DEFAULT
Supporting analytical detail for FSHR relative potency Sample units 3 finished containers Analytical replicates 2 biological endpoint Separate FSHR and LHCGR cAMP bioactivity assaysMethod and sample context; reference facts are in Identity Reference. assay system Specified receptor-cell reporter or casein initial-rate assay for bromelain; see endpoint-specific raw data.Method and sample context; reference facts are in Identity Reference. reference standard and activity SIM activity standard with a 100% relative assignment. The gonadotropin reference carries the same nominal IU/vial as the label.Method and sample context; reference facts are in Identity Reference. activity unit definition Relative potency = reference EC50 / sample EC50 x 100. IU/vial = assigned reference IU x relative potency / 100, with equal nominal preparation factors.Method and sample context; reference facts are in Identity Reference. concentration response range 0.01, 0.03, 0.1, 0.3, 1, 3, 10 and 30 times the normalized reference EC50; no absolute EC50 is invented.Method and sample context; reference facts are in Identity Reference. curve fit 4PL: bottom 2, top 100, Hill slope 1 and run-specific EC50; three independent runs with duplicate wells.Method and sample context; reference facts are in Identity Reference. controls Reference, vehicle blank and assay window; curve parameters are declared.Method and sample context; reference facts are in Identity Reference. biological replicates 3 Explicit context; see valueMethod and sample context; reference facts are in Identity Reference. confidence interval 99.8748 to 100.4721
LHCGR relative potencyRelative to the specified reference response; activity units and mass units are evaluated separately. Method validation is not asserted by this report.	100.173 % reference response potencyPASS	90 to 110% reference response potency	M-T16-DEFAULT
Supporting analytical detail for LHCGR relative potency Sample units 3 finished containers Analytical replicates 2

T17Protein and conjugate characterization

Test / endpoint	Result	Acceptance criterion	Method
Size-exclusion main defined populationSame primary SEC population result as T02 for proteins; orthogonal size separation for PEG/mixtures. Includes expected biological heterogeneity.	99.91 % SEC responsePASS	99.7 to 100% SEC response	M-T17-DEFAULT
Supporting analytical detail for Size-exclusion main defined population Sample units 3 finished containers Analytical replicates 2 PEG attachment site The N-alpha amine at residue 1 for the specified PEG-MGF reference; not assumed for other materials.Method and sample context; reference facts are in Identity Reference. conjugated to free fraction Free core peptide and free PEG are quantified separately, where applicable; covalent attachment cannot be inferred from peptide-core mass.Method and sample context; reference facts are in Identity Reference. glycosylation The reference glycoform population is retained for glycoproteins; no universal exact glycan mass is assigned. E. coli-derived LR3 is nonglycosylated.Method and sample context; reference facts are in Identity Reference. oligomer or chain state Fc-linked homodimer for ACE-031 and dulaglutide; hCG heterodimer; LR3 single chain. See Identity Reference.Method and sample context; reference facts are in Identity Reference. reduction or deglycosylation A specialized orthogonal record is provided where applicable; reduction or deglycosylation is not implicitly performed.Method and sample context; reference facts are in Identity Reference. aggregate fraction See the T17 SEC population and HMW/LMW rows.Method and sample context; reference facts are in Identity Reference.
High molecular weight aggregate fractionspecified sample/form only	0.045 % SEC responsePASS	<= 0.1% SEC response	M-T17-DEFAULT
Supporting analytical detail for High molecular weight aggregate fraction Sample units 3 finished containers Analytical replicates 2
Low molecular weight non-reference fractionspecified sample/form only	0.045 % SEC responsePASS	<= 0.1% SEC response	M-T17-DEFAULT
Supporting analytical detail for Low molecular weight non-reference fraction Sample units 3 finished containers Analytical replicates 2
Orthogonal construct/fingerprint mappingIdentity Reference defines construct, termini, and mixture caveats; no raw mass spectrum or gel image exists	Conforms to explicit reference specificationPASS	Conforms to the specified acceptance criterion	M-T17-DEFAULT
Supporting analytical detail for Orthogonal construct/fingerprint mapping Sample units 3 finished containers Analytical replicates 2
Released N-glycan composition-profile cosine similarityCosine similarity of complete response-corrected fraction vectors to explicit reference; no site/linkage assignment	1 similarity0-1Recorded numeric value: 0.9999997294317454PASS	0.995 to 1similarity0-1	M-T17-GLYCAN-COMPOSITION-PROFILE
Supporting analytical detail for Released N-glycan composition-profile cosine similarity Sample units 3 finished containers Analytical replicates 2
hCG-fraction O-glycan composition-profile recoverySeparate35:65 mono-/disialylated Hex1HexNAc1 composition profile; independent of N-glycan table	100 % assigned reference fractionsPASS	98 to 102% assigned reference fractions	M-T17-HCG-O-GLYCAN-PROFILE
Supporting analytical detail for hCG-fraction O-glycan composition-profile recovery Sample units 3 finished containers Analytical replicates 2
Nonreducing CE-SDS intended chain-population fractionProtein-specific reference profile; hCG/HMG expected alpha/beta subunits are intended species, not degraded monomer	99.85 % integrated CE-SDS areaPASS	99.7 to 100% integrated CE-SDS area	M-T17-PROTEIN-CHAIN-PROFILE
Supporting analytical detail for Nonreducing CE-SDS intended chain-population fraction Sample units 3 finished containers Analytical replicates 2
Reducing CE-SDS intended chain-population fractionProtein-specific reference profile; hCG/HMG expected alpha/beta subunits are intended species, not degraded monomer	99.85 % integrated CE-SDS areaPASS	99.7 to 100% integrated CE-SDS area	M-T17-PROTEIN-CHAIN-PROFILE
Supporting analytical detail for Reducing CE-SDS intended chain-population fraction Sample units 3 finished containers Analytical replicates 2

T18Process impurities

Test / endpoint	Result	Acceptance criterion	Method
Residual source-process protein impuritiesurinary-source gonadotropin process; source-specific assay. For hydrolysates, intact source proteins outside the target digest are measured by selective separation; intended peptides are not HCP impurities.	2.1 ng/vialPASS	<= 100ng/vial	M-T18-DEFAULT
Supporting analytical detail for Residual source-process protein impurities Limit of detection 0.2 ng/vial Limit of quantitation 0.6 ng/vial Sample units 3 finished containers Analytical replicates 2 process impurity identity Source-process protein and source DNA; Protein A only in the Fc-affinity scenario.Method and sample context; reference facts are in Identity Reference. HCP assay coverage source-specific coverage; intended hydrolysate proteins are not classified as HCP impurities.Method and sample context; reference facts are in Identity Reference. DNA extraction recovery spike recovery: 98.6%.Method and sample context; reference facts are in Identity Reference. process stage Process-residue test of the finished unit; not actual upstream process validation.Method and sample context; reference facts are in Identity Reference. assay control scope Source-specific positive control, extraction blank and matrix spike.Method and sample context; reference facts are in Identity Reference.
Residual source DNASource-specific qPCR in process; extraction recovery demonstrated only	0.012 ng/vialPASS	<= 1ng/vial	M-T18-DEFAULT
Supporting analytical detail for Residual source DNA Limit of detection 0.001 ng/vial Limit of quantitation 0.003 ng/vial Sample units 3 finished containers Analytical replicates 2

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.	99.9101 % of initial assayPASS	98 to 102% of initial assay	M-T20-DEFAULT
Supporting analytical detail for Reported 6 month assay retention Sample units 3 finished containers Analytical replicates 2 study protocol id STAB-P2630-SIMPLEMethod 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.
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-DEFAULT: Chromatographic purityRP-UPLC DAD; SEC for protein size species; HILIC/CAD for nonchromophoric analytes
M-T05-DEFAULT: Related substancesStability-indicating LC integration; orthogonal size/charge separation for biologics
M-T03-BIOACTIVITY: Gonadotropin activity content against an IU-assigned referenceReceptor-specific relative biological-potency calibration and IU accounting
M-T04-DEFAULT: Component-resolved blend assaySeparate calibrated selective assay for every declared component
M-T15-DEFAULT: Individual-unit uniformityTen separate unit preparations and fill measurements
M-T06-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-T17-GLYCAN-COMPOSITION-PROFILE: Released N-glycan composition-profile comparisonPNGase-F release with composition-resolved, response-calibrated LC-MS
M-T17-HCG-O-GLYCAN-PROFILE: hCG beta-contributing O-glycan composition profileC-terminal hCG beta glycopeptide LC-MS/MS with desialylation controls
M-T17-PROTEIN-CHAIN-PROFILE: Reference-defined reduced/nonreducing protein-chain populationsCE-SDS with independent chain-reference migration and subunit identity comparison
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.