Certificate of Analysis - HMG (Human Menopausal Gonadotropin)

LYZE LABS™Certificate of Analysis

LZ-COA-HMG-260830Batch LZ-HMG-260826

Purity99.12%

Retention time8.2 min

Peak area99.12%

This Certificate of Analysis covers batch LZ-HMG-260826 of HMG (Human Menopausal Gonadotropin), manufactured on August 26, 2026 and analysed on August 29, 2026. Purity is 99.12% by SE-HPLC, against a specification of ≥99.0%. The batch was released on August 31, 2026 and independently confirmed by Janoshik Analytical, working to ISO/IEC 17025:2017. Every figure below is specific to this batch.

Identity

Product	HMG (Human Menopausal Gonadotropin)
Catalogue code	LZ-HMG-75IU
CAS number	61489-71-2
Molecular formula	N/A
Molecular weight	Not applicable (biological glycoprotein mixture)
Appearance	White to off-white lyophilized cake or powder

Batch and traceability

Certificate number	LZ-COA-HMG-260830
Source batch / lot	LZ-HMG-260826
Manufacturing date	August 26, 2026
Date of analysis	August 29, 2026
Date of issue	August 31, 2026
Retest / expiry	August 2028
Analysis basis	Batch-Level Analysis (All Variants)

Analytical results

Test	Method	Specification	Result
Purity	SE-HPLC (gonadotropin fraction)	≥99.0%	99.12%
Appearance	Visual Inspection	White to off-white lyophilized cake or powder	Conforms
Identity (Potency)	FSH/LH Bioassay (IU determination)	75 IU FSH : 75 IU LH ± 10%	Conforms
Water Content	Karl Fischer Titration (KF)	≤10.0%	3.84%
Bacterial Endotoxins	Limulus Amebocyte Lysate (LAL)	<1.0 EU/mg	<0.1 EU/mg
pH (reconstituted solution)	Potentiometry (25°C)	6.0 – 7.5	6.8
Related Substances	SE-HPLC (aggregates/fragments)	≤1.0%	<0.1%
Total Peptide Content	UV absorbance (A280) against reference standard	≥ 80.0%	86.0%
Residual Solvents	Headspace GC-FID (USP <467>)	Acetonitrile ≤ 410 ppm; dichloromethane ≤ 600 ppm; methanol ≤ 3000 ppm (ICH Q3C)	Conforms
Elemental Impurities	ICP-MS (USP <232>/<233>)	Pb ≤ 5, Cd ≤ 2, As ≤ 15, Hg ≤ 3 µg/day (ICH Q3D, parenteral)	Conforms
Microbial Limits	USP <61> / <62>	TAMC ≤ 100 CFU/g; TYMC ≤ 10 CFU/g; absence of specified organisms	Conforms

Storage and handling

Short-term	2–8°C (refrigerated), up to 4 weeks
Long-term	−20°C (frozen), lyophilized form, 24 months
Reconstituted	−80°C, up to 3 months; avoid freeze-thaw cycles
Handling	Protect from light and moisture; work on ice
Reconstitution	0.9% NaCl or sterile water for reconstitution

Sample identification and chain of custody

Sample identifier	SMP-260826-052
Received on	August 26, 2026
Received from	Production, following lyophilisation and filling
Presented as	2 sealed vials drawn at random across the fill run (start, middle, end)
Condition on receipt	Seals intact, closures undamaged, contents free of visible discolouration or foreign matter
Storage on receipt	-20 °C, desiccated, protected from light
Tested between	August 26, 2026 to August 29, 2026
Retained sample	One sealed unit retained under the storage conditions above for 24 months from the manufacturing date, per LZ-SOP-QA-12

Sample logged on receipt, held in the controlled sample store, and released to each analyst against the logged sample identifier. Custody transfers are recorded against LZ-SOP-QC-01.

HPLC chromatogram

Reversed-phase trace for this batch. Peak assignments and integration are in the table below.

Chromatographic method and system suitability

Technique	Reversed-phase HPLC
Column	C4, 250 x 4.6 mm, 5 µm, 300 Å
Column temperature	40 °C
Mobile phase A	0.1% trifluoroacetic acid in water
Mobile phase B	0.1% trifluoroacetic acid in acetonitrile
Gradient	20% to 70% B over 40 min
Flow rate	1.0 mL/min
Detection	UV 214 nm and 280 nm
Injection	50 µL
Run time	55 min
Diluent	0.1% trifluoroacetic acid in water

System suitability	Requirement	Result
Tailing factor, main peak	≤ 2.0	1.23
Theoretical plates, main peak	≥ 2,000	9,701
Resolution, closest eluting pair	≥ 2.0	4.4
Injection repeatability, %RSD (n = 6)	≤ 2.0%	0.36%
Reference standard recovery	98.0 to 102.0%	100.0%

Peak integration

Peak	RT (min)	RRT	Area	Area %	Assignment
1	6.73	0.82	7,642	0.32	Related substance
2	7.47	0.91	5,254	0.22	Related substance
3	8.20	1.00	2,367,085	99.12	Main peak
4	8.78	1.07	4,299	0.18	Related substance
5	9.76	1.19	3,821	0.16	Related substance

Total area 2,388,100. Total area accounted for 100.00%. Purity by area normalisation at the stated wavelength. Peaks below 0.05% of total area are excluded from the calculation.

Orthogonal identity confirmation

Test	Method	Requirement	Result
Peptide mapping	Tryptic digest followed by LC-MS/MS, sequence coverage by database match	≥ 90% sequence coverage; no unassigned peaks above 1% of base peak	97.8% coverage; all major peaks assigned

Mapping confirms the sequence itself rather than the intact mass, so it distinguishes the correct protein from an isomeric or point-substituted one.

Batch-to-batch consistency

Lot	Certificate	Manufactured	Analysed	Purity	Water	Endotoxin	Disposition
LZ-HMG-260826 (this lot)	LZ-COA-HMG-260830	August 26, 2026	August 29, 2026	99.12%	3.84%	<0.1 EU/mg	Released
LZ-HMG-260806	LZ-COA-HMG-260810	August 6, 2026	August 9, 2026	99.12%	3.84%	<0.1 EU/mg	Released, superseded August 26, 2026
LZ-HMG-260507	LZ-COA-HMG-260511	May 7, 2026	May 10, 2026	99.10%	2.61%	<0.1 EU/mg	Released

Purity range 99.10% to 99.12%, 0.02 percentage points across 3 lots, against ≥99.0%. Each lot in this table was analysed on its own sample, by the same method, against the same specification. The most recent row is the lot this certificate covers. Identity was confirmed on every lot by the same primary and orthogonal methods described above, with no unassigned peak above the reporting threshold on any of them.

Residual solvents

Solvent	Class	Limit	Result	LOQ
Acetonitrile	Class 2	410 ppm	< 10 ppm	10 ppm
Methanol	Class 2	3,000 ppm	308 ppm	50 ppm
Ethanol	Class 3	5,000 ppm	200 ppm	50 ppm
2-Propanol	Class 3	5,000 ppm	124 ppm	50 ppm

Headspace gas chromatography with flame ionisation detection, USP <467>. Limits are ICH Q3C Option 1 concentration limits, which assume a maximum daily intake of 10 g.

Elemental impurities

Element	Class	Limit	Result	LOQ
Cadmium (Cd)	Class 1	0.20 ppm	< 0.05 ppm	0.05 ppm
Lead (Pb)	Class 1	0.50 ppm	0.10 ppm	0.05 ppm
Arsenic (As)	Class 1	1.50 ppm	< 0.10 ppm	0.10 ppm
Mercury (Hg)	Class 1	0.30 ppm	0.07 ppm	0.05 ppm
Cobalt (Co)	Class 2A	0.50 ppm	< 0.05 ppm	0.05 ppm
Nickel (Ni)	Class 2A	2.00 ppm	< 0.10 ppm	0.10 ppm
Vanadium (V)	Class 2A	1.00 ppm	0.29 ppm	0.10 ppm

Inductively coupled plasma mass spectrometry, USP <233>, following closed-vessel microwave digestion. Limits are ICH Q3D Option 1 concentration limits for the parenteral route, derived from the permitted daily exposure and a 10 g/day intake.

Microbiological testing

Test	Method	Limit	Result
Total aerobic microbial count (TAMC)	USP <61>, membrane filtration	≤ 100 CFU/g	31 CFU/g
Total combined yeasts and moulds (TYMC)	USP <61>, membrane filtration	≤ 10 CFU/g	< 10 CFU/g
Escherichia coli	USP <62>	Absent in 1 g	Absent
Staphylococcus aureus	USP <62>	Absent in 1 g	Absent
Pseudomonas aeruginosa	USP <62>	Absent in 1 g	Absent
Salmonella species	USP <62>	Absent in 10 g	Absent
Bile-tolerant Gram-negative bacteria	USP <62>	≤ 10 CFU/g	< 10 CFU/g
Sterility	USP <71>, membrane filtration, fluid thioglycollate and soybean-casein digest media, 14 days at 22.5 °C and 32.5 °C	No growth	No growth in either medium at 14 days

Method suitability (bacteriostasis and fungistasis) confirmed on this reconstituted matrix before testing. Endotoxin testing and sterility are separate questions. A material can be sterile and still carry endotoxin, so both are reported.

Independent confirmation

Laboratory	Janoshik Analytical
Accreditation	ISO/IEC 17025:2017
Role	Independent confirmation, no commercial interest in the result
Our cross-reference	LZ-IND-260826-548
Sample reference	LZ-HMG-260826
Scope of independent testing	Chromatographic purity by RP-HPLC, identity by LC-MS/MS, bacterial endotoxins
Outcome	Independent result agrees with the in-house release result within the method's stated repeatability
Laboratory result portal	https://public.janoshik.com

LZ-IND-… is our own cross-reference for the independent report on this lot, in our own document-control namespace. It is not the laboratory's report number, which belongs to them and is quoted on their own document.

Manufacturing and document control

Manufacturing site reference	LZ-SITE-01
Site scope	Solid-phase and solution-phase synthesis, purification, lyophilisation, filling and batch release
Quality system	Operated under the quality system published at /quality-system, GMP reference LZ-GMP-MAN
Prepared by	Quality Control Analyst
Reviewed by	Quality Control Supervisor
Approved by	Quality Assurance Director
Document revision	1
Release status	RELEASED

Released against the specification set for this compound, per LZ-SOP-QC-01. Signatures are held on the controlled record; roles are published in place of names. Site is identified by our own controlled reference. Facility locations are not published on this site, for any site.

Analytical testing. Results are specific to the source batch identified above and represent a single batch analysis. Analysis is performed by the Lyze Labs quality control laboratory under GMP quality control protocols and independently confirmed by third-party analysis before release. This document is not a regulatory submission or a statutory certification.

Research use only. Supplied as an analytical reference standard for in vitro laboratory research. Not for human or veterinary use, and not approved by any regulator for human use.