Certificate of Analysis · Lot release · Issued for Epic Wholesalers LLC -dba-Epic Peptides Lab
Triptorelin 2 mg Nasal Spray
Lot PL-2610-226 · Solution · Label claim 2 mg per bottle
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-226
Date made
2026-10-07
Date of analysis
2026-10-08
Date issued
2026-10-14
Retest / expiry
2028-10-07
Units in lot / sampled
359 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Triptorelin
[D-Trp6]-GnRH
CAS number
57773-63-4
Molecular formula
C64H82N18O13
Theoretical mass (avg.)
1,311.45 Da
Sequence
pEHWSY-D-Trp-LRPG-NH2
Purity · RP-HPLC, area %
99.65%
Specification ≥ 99.0% • main peak at 13.00 min
Identity · Observed Mass
1,311.49 Da
Theoretical 1,311.45 Da • +0.04 Da (31 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
Identity (mass)
LC-MS, ESI positive
Theoretical ± 1.0 Da
1,311.49 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.65%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.17% (RT 11.70)
PASS
Assay (label claim)
Assay vs label claim
1.9–2.1 mg/bottle
1.96 mg/bottle
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.251 EU/mg
PASS
Aerobic count (TAMC)
USP <61>
< 10 CFU/mL
< 10 CFU/mL
PASS
Yeast & mold (TYMC)
USP <61>
< 10 CFU/mL
< 10 CFU/mL
PASS
E. coli
USP <62>
Absent
Absent
PASS
1HPLC chromatogram
Data file: PL-2610-226-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-226-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
Peaks: 1 tryptophan oxidation product; 2 deamidation product; 3 main peak (Triptorelin); 4 truncated sequence · Area % from the integrated peak table (absolute areas are not part of the lot-release export) · † nominal reference RT for the assigned impurity · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.
5Identity by mass spectrometry
Instrument
Waters SQD
Ionization / Mode
ESI, positive
Reference m/z (charge)
656.73 (2+) · 438.16 (3+)
Deconvoluted Mass
1,311.49 Da
Theoretical Mass
1,311.45 Da
Difference
+0.04 Da (31 ppm)
Data File
PL-2610-226-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
PrymaLab Analytical
2026-10-08
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-08
—
Microbial limits (USP <61>/<62>)
PrymaLab Analytical
2026-10-14
—
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: 2026-10-14
S. Calloway Reviewer · checked against raw data Date: 2026-10-14
M. Phelps Lab Director · approved for release Date: 2026-10-14