Certificate PL-26-00045 · Gonadorelin 2 mg · lot PL-2609-045
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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-26-00045
Verification key
M8RAHAVY
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Certificate of Analysis · Lot release

Gonadorelin 2 mg

Lot PL-2609-045 · Lyophilized powder · Label claim 2 mg/vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-045
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
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
Gonadorelin
Native gonadotropin-releasing hormone (GnRH, LHRH)
CAS number
33515-09-2
Molecular formula
C55H75N17O13
Theoretical mass (avg.)
1182.3 Da
Sequence
pGlu-HWSYGLRPG-NH₂ (10 residues; N-terminal pyroglutamate; C-terminal amide)
Purity · RP-HPLC, area %
99.24%
Specification 99.0% • main peak at 4.82 min
Identity · Observed Mass
1182.5 Da
Theoretical 1182.3 Da • +0.2 Da (169 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
AppearanceVisual inspectionWhite to off-white lyophilized powderWhite lyophilized powderPASS
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da1182.5 DaPASS
PurityRP-HPLC, UV 214 nm, area%99.0%99.24%PASS
Largest impurityRP-HPLC, area%1.0%0.32% at 5.56 minPASS
Water contentKarl Fischer5.0%1.9%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.04 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: GNR_PL-2609-045_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) Gonadorelin (GnRH) — 99.24% @ 4.82 min 0.25% @ 4.06 0.32% @ 5.56 0.19% @ 6.32
Baseline uncropped; main peak and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Gonadorelin 2 mg · Lot PL-2609-045 · Certificate PL-26-00045
Lot PL-2609-045
Method, peak table and approval

2HPLC method · GNR_PL-2609-045_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
0.5 mg/mL
Blank Injected
Yes
Reference Standard
In-house Gonadorelin reference, lot PL-RS-GNR-01, RT 4.80 min

3Gradient program

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

4Peak table

PeakRT (min)AreaArea %
14.0610,7500.25
24.824,267,32099.24
35.5613,7600.32
46.328,1700.19
Total4,300,000100.00
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)
1183.3 (1+ [M+H]) · 1205.3 (1+ [M+Na])
Deconvoluted Mass
1182.5 Da
Theoretical Mass
1182.3 Da
Difference
+0.2 Da (169 ppm)
Data File
GNR_PL-2609-045_MS_20260919_01
Acceptance
Within ± 1.0 Da

6Additional tests

TestPerformed byDateReport / file
Water contentPrymaLab2026-09-20RPT-KF-PL-2609-045
EndotoxinPrymaLab2026-09-21RPT-ET-PL-2609-045
SterilityPrymaLab2026-10-02RPT-ST-PL-2609-045
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