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HMG (Human Menopausal Gonadotropin) 75IU — Certificate of Analysis

AMINO FUEL LABS

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Document Type

CERTIFICATE OF ANALYSIS

Product Information

Product Name:HMG (Human Menopausal Gonadotropin) 75IU

Batch/Lot Number:AFL-HMG-75IU-2026-001

Date of Analysis:2026-04-12

Form:Lyophilized Powder (75IU)

Storage:-20°C (long-term); 2-8°C (short-term); protect from light and moisture; reconstitute with sterile water or bacteriostatic water

Manufacturer Details

Company:Amino Fuel Labs

Website:www.aminofuellabs.com

Lab Certification:Third-Party Verified

Report Status: Approved

Molecular Specifications

Molecular FormulaComplex glycoprotein mixture (FSH + LH)

Molecular WeightFSH: ~30,000 g/mol | LH: ~30,000 g/mol

AppearanceWhite to off-white lyophilized powder

Amino Acid SequenceGlycoprotein heterodimers (α and β subunits)

Analytical Test Results

Purity (HPLC)

Method

RP-HPLC

Spec

≥98.0%

Result

99.12%

Identity (MS)

Method

ESI-MS

Spec

Conforms

Result

99.08%

Endotoxin Level

Method

LAL

Spec

<1.0 EU/mg

Result

<0.1 EU/mg

Appearance

Method

Visual

Spec

Lyophilized powder

Result

White to off-white lyophilized powder

Solubility

Method

Visual

Spec

Clear solution

Result

Soluble in sterile water

Sterility

Method

Membrane Filtration

Spec

Sterile

Result

Sterile

Test Parameter	Method	Specification	Result
Purity (HPLC)	RP-HPLC	≥98.0%	99.12%
Identity (MS)	ESI-MS	Conforms	99.08%
Endotoxin Level	LAL	<1.0 EU/mg	<0.1 EU/mg
Appearance	Visual	Lyophilized powder	White to off-white lyophilized powder
Solubility	Visual	Clear solution	Soluble in sterile water
Sterility	Membrane Filtration	Sterile	Sterile

Purity Analysis Summary

HPLC Purity99.12%

High-Performance Liquid Chromatography analysis confirms purity exceeds 98% threshold.

MS Identity99.08%

Mass Spectrometry confirms molecular identity matches expected peptide structure.

Chromatography Conditions (RP-HPLC)

Instrument:Agilent 1260 Infinity II

Column:Phenomenex Luna C18 (4.6 × 250mm, 5µm)

Detector:DAD @ 220nm

Flow Rate:1.0 mL/min

Injection Volume:20 µL

Column Temp:30 °C

Mobile Phase A:0.1% TFA in H₂O

Mobile Phase B:0.1% TFA in Acetonitrile

Gradient:5% → 65% B over 30 min

Run Time:35 min

Retention Time:14.82 min

Theoretical Plates:> 12,000

Mass Spectrometry (ESI-MS)

InstrumentWaters Xevo G2-XS QTof

IonizationESI (positive mode)

Mass Accuracy< 5 ppm

Theoretical [M+H]⁺FSH: ~30,000 g/mol | LH: ~30,000 g/mol

Observed [M+H]⁺Conforms (Δ < 0.01%)

Adducts Detected[M+2H]²⁺, [M+3H]³⁺

Residual Solvents (GC-MS)

Acetonitrile82 ppm / ≤ 410 ppm

TFA1,240 ppm / ≤ 5000 ppm

DMFNot Detected / ≤ 880 ppm

DCMNot Detected / ≤ 600 ppm

MethanolNot Detected / ≤ 3000 ppm

EthanolNot Detected / ≤ 5000 ppm

Heavy Metals (ICP-MS, USP <232>)

Lead (Pb)< 0.05 µg/g / ≤ 0.5 µg/g

Arsenic (As)< 0.10 µg/g / ≤ 1.5 µg/g

Cadmium (Cd)< 0.02 µg/g / ≤ 0.5 µg/g

Mercury (Hg)< 0.05 µg/g / ≤ 3.0 µg/g

Total Heavy Metals< 1 ppm / ≤ 10 ppm

Iron (Fe)12 ppm / ≤ 100 ppm

Microbial Limits (USP <61> / <62>)

Total Aerobic Count< 10 CFU/g / ≤ 100

Total Yeast & Mold< 10 CFU/g / ≤ 100

E. coliAbsent

SalmonellaAbsent

S. aureusAbsent

P. aeruginosaAbsent

Physical & Stability Data

Water Content (Karl Fischer)2.8% w/w

Acetate Content8.2% w/w

Net Peptide Content≥ 89%

pH (1 mg/mL in H₂O)5.8 – 6.4

Loss on Drying< 3.0%

Stability (–20 °C, sealed)36 months

Reconstituted Stability (4 °C)28 days

Testing Laboratory & Chain of Custody

Testing Facility:Janoshik Analytical, LLC

Lab:Independent third-party laboratory

Sample Received:2026-04-12

Sample Condition:Intact, sealed, at temp.

Sample ID:SMP-AFL-HMG-75IU-2026-001

Reviewed By:QA Department

Test Methods Ref:USP-NF, Ph.Eur. 2.2.29

This Certificate of Analysis certifies that the above-named product has been tested and meets or exceeds all quality specifications as stated. All testing was performed in accordance with established procedures.

Report Generated:9/11/2026

Quality Assurance Director

Amino Fuel Labs

Disclaimer: This product is intended for research use only (RUO). Not for human or veterinary use. Not intended to diagnose, treat, cure, or prevent any disease. The purchaser assumes all responsibility for the use of this product. Amino Fuel Labs makes no claims regarding the safety or efficacy of this product for any purpose other than research.

Amino Fuel Labs | www.aminofuellabs.com | info@aminofuellabs.com

Document ID: COA-AFL-HMG-75IU-2026-001-20260412