Certificate of Analysis · Lot release · Issued for Epic Wholesalers LLC -dba-Epic Peptides Lab
Thymogen 10 mg Nasal Spray
Lot PL-2610-210 · Solution · Label claim 10 mg per bottle
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-210
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
283 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Thymogen
Glu-Trp dipeptide (EW); oglufanide
CAS number
38101-59-6
Molecular formula
C16H19N3O5
Theoretical mass (avg.)
333.34 Da
Sequence
EW
Purity · RP-HPLC, area %
99.67%
Specification ≥ 99.0% • main peak at 5.32 min
Identity · Observed Mass
333.33 Da
Theoretical 333.34 Da • −0.01 Da (30 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
333.33 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.67%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.15% (RT 6.10)
PASS
Assay (label claim)
Assay vs label claim
9.5–10.5 mg/bottle
9.78 mg/bottle
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.302 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-2610-210-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-2610-210-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
Peaks: 1 unidentified impurity; 2 main peak (Thymogen); 3 unidentified impurity; 4 unidentified impurity · 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)
334.35 (M+H)+
Deconvoluted Mass
333.33 Da
Theoretical Mass
333.34 Da
Difference
−0.01 Da (30 ppm)
Data File
PL-2610-210-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