Certificate of Analysis · Lot release · Issued for Epic Wholesalers LLC -dba-Epic Peptides Lab
Vesilute 50 mg Pen
Lot PL-2610-229 · Solution · Label claim 50 mg/mL
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-229
Date made
2026-10-08
Date of analysis
2026-10-09
Date issued
2026-10-23
Retest / expiry
2028-10-08
Units in lot / sampled
241 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Vesilute
Glu-Asp dipeptide (ED)
CAS number
n/a
Molecular formula
C9H14N2O7
Theoretical mass (avg.)
262.20 Da
Sequence
ED
Purity · RP-HPLC, area %
99.71%
Specification ≥ 99.0% • main peak at 8.95 min
Identity · Observed Mass
262.19 Da
Theoretical 262.20 Da • −0.01 Da (38 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
262.19 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.71%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.19% (RT 10.50)
PASS
Assay (label claim)
Assay vs label claim
47.5–52.5 mg/mL
50.78 mg/mL
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.015 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-229-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-2610-229-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
Epic Wholesalers LLC -dba-Epic Peptides Lab
Certificate of Analysis · continued
Vesilute 50 mg Pen · Lot PL-2610-229 · Certificate PL-26-00342
Lot PL-2610-229
Method, peak table and approval
2HPLC method · PL-2610-229-HPLC.raw
Instrument
Waters Alliance e2695
Data System
Empower 3
Detector
UV absorbance
Detection Wavelength
214 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Gradient
5–95% B over 25 min (linear)
Flow Rate
1.0 mL/min
Column Temperature
40 °C
Injection Volume
10 µL
3Gradient program
Time (min)
% A
% B
0.0
95
5
25.0
5
95
4Peak table
Peak
RT (min)
Area
Area %
1
7.90 †
—
0.03
2
8.95
—
99.71
3
9.90 †
—
0.07
4
10.50 †
—
0.19
Total
—
100.00
Peaks: 1 unidentified impurity; 2 main peak (Vesilute); 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)
263.21 (M+H)+
Deconvoluted Mass
262.19 Da
Theoretical Mass
262.20 Da
Difference
−0.01 Da (38 ppm)
Data File
PL-2610-229-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
PrymaLab Analytical
2026-10-09
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-09
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-23
—
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: 2026-10-23
S. Calloway Reviewer · checked against raw data Date: 2026-10-23
M. Phelps Lab Director · approved for release Date: 2026-10-23
