Certificate PL-26-00050 · HMG 75 IU · lot PL-2609-050
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PrymaLab
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00050
Verification key
FH5H6QV5
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Certificate of Analysis · Lot release

HMG 75 IU

Lot PL-2609-050 · Lyophilized powder · Label claim 75 IU/vial (75 IU FSH + 75 IU LH activity)
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-050
Date made
2026-09-18
Date of analysis
2026-09-19
Date issued
2026-10-03
Retest / expiry
2028-09-18
Units in lot / sampled
250 / 2
Storage
2–8 °C, dark
Certificate type
Lot COA, 2 pages
Compound
HMG (Menotropins)
Human menopausal gonadotropin: urinary FSH and LH; potency assigned in IU by bioassay
CAS number
61489-71-2
Molecular formula
Not applicable (glycoprotein mixture)
Theoretical mass (avg.)
FSH about 30 kDa and LH about 28.5 kDa glycoform averages
Structure
Co-purified glycoprotein heterodimers: FSH = common α-subunit (92 aa) + FSHβ (111 aa); LH = common α-subunit (92 aa) + LHβ (121 aa); cystine-knot fold; N-glycosylated.
Purity · RP-HPLC, area %
98.6%
Specification ≥ 95.0% (SDS-PAGE corroboration) • FSH/LH component peaks at 6.92 / 7.34 min
Identity · Observed Mass
2 / 2
Both gonadotropin components confirmed by LC-MS within glycoform envelopes: FSH ~30 kDa · LH ~28.5 kDa
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
AppearanceVisual inspectionWhite to off-white lyophilized powder or cakeWhite lyophilized cakePASS
IdentityLC-MS, ESI positiveFSH/LH within glycoform envelopesFSH 30,084 Da · LH 28,577 Da centroidsPASS
PurityRP-HPLC, UV 214 nm, area%≥ 95.0%98.6%
Largest impurityRP-HPLC, area%≤ 5.0%0.8% at 7.82 minPASS
Water contentKarl Fischer5.0%1.8%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.23 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: HMG_PL-2609-050_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) HMG — FSH 49.0% @ 6.92 min LH 49.6% @ 7.34 0.5% @ 6.24 0.8% @ 7.82 0.1% @ 8.41
Baseline uncropped; FSH and LH component peaks (both shaded) and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
HMG 75 IU · Lot PL-2609-050 · Certificate PL-26-00050
Lot PL-2609-050
Method, peak table and approval

2HPLC method · HMG_PL-2609-050_20260919_01

Instrument
Waters Alliance e2695, SN E2695B742
Data System
Empower 3, Build 3471
Detector
Waters 2998 PDA
Detection Wavelength
214 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Column Part / Serial
186003326 / USHX18211
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Flow Rate
1.0 mL/min
Column Temperature
30 °C
Injection Volume
20 µL
Run Time
10 min
Sample Diluent
Water, 0.1% TFA
Sample Concentration
0.2 mg/mL (pooled composite)
Blank Injected
Yes
Reference Standard
In-house HMG reference, lot PL-RS-HMG-01, component RTs 6.90 / 7.32 min

3Gradient program

Time (min)% A% B
0.0955
3.0955
7.05545
8.02080
9.02080
10.0955

4Peak table

PeakRT (min)AreaArea %
16.2421,5000.5
2 (FSH)6.922,107,00049.0
3 (LH)7.342,132,80049.6
47.8234,4000.8
58.414,3000.1
Total4,300,000100.0
Threshold 0.05% area · Blank subtracted: Y · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.

5Identity by mass spectrometry

Instrument
Waters Acquity SQD
Ionization / Mode
ESI, positive
Observed m/z (charge)
1505.2 (20+ [M+20H], FSH) · 1144.6 (25+ [M+25H], LH)
Deconvoluted Mass
FSH 30,084 Da · LH 28,577 Da (glycoform centroids)
Theoretical Mass
FSH ~30,000 Da · LH ~28,500 Da (average glycoforms)
Difference
Within CHO-derived (urinary) glycoform envelopes
Data File
HMG_PL-2609-050_MS_20260919_01
Acceptance
Within glycoform envelopes, each component

6Additional tests

TestPerformed byDateReport / file
Water contentPrymaLab2026-09-20RPT-KF-PL-2609-050
EndotoxinPrymaLab2026-09-21RPT-ET-PL-2609-050
SterilityPrymaLab2026-10-02RPT-ST-PL-2609-050
A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.

7Review and approval

D. Reynolds
Analyst · performed the testing
Date: 2026-09-19
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-02
M. Phelps
Lab Director · approved for release
Date: 2026-10-03