Certificate PL-26-00309 · SS-31 Elamipretide 10 mg Pen · lot PL-2610-196 · branded for Epic Wholesalers LLC -dba-Epic Peptides Lab
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Epic Wholesalers LLC -dba-Epic Peptides Lab
Epic Wholesalers LLC -dba-Epic Peptides Lab
Certificate of Analysis · Lot release
www.epicpeptideslab.com
Certificate no.
PL-26-00309
Verification key
SNN6DXFW
Scan or enter both at
prymalab.net/testing/verify

Certificate of Analysis · Lot release · Issued for Epic Wholesalers LLC -dba-Epic Peptides Lab

SS-31 Elamipretide 10 mg Pen

Lot PL-2610-196 · Solution · Label claim 10 mg/mL
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-196
Date made
2026-10-07
Date of analysis
2026-10-08
Date issued
2026-10-22
Retest / expiry
2028-10-07
Units in lot / sampled
193 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
SS-31
Elamipretide (SS-31, MTP-131); D-Arg-Dmt-Lys-Phe-NH2
CAS number
736992-21-5
Molecular formula
C32H49N9O5
Theoretical mass (avg.)
639.78 Da
Sequence
D-Arg-Dmt-Lys-Phe-NH2
Purity · RP-HPLC, area %
99.73%
Specification ≥ 99.0% • main peak at 8.95 min
Identity · Observed Mass
639.75 Da
Theoretical 639.78 Da • −0.03 Da (47 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da639.75 DaPASS
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.73%PASS
Largest impurityRP-HPLC, area%≤ 1.0%0.13% (RT 9.80)PASS
Assay (label claim)Assay vs label claim9.5–10.5 mg/mL9.80 mg/mLPASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.285 EU/mgPASS
SterilityUSP <71>, 14-dayNo growthNo growthPASS

1HPLC chromatogram

Data file: PL-2610-196-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%6789101112Retention time (min) · stick height = area % (log scale)99.73% · 8.95 min0.03% †0.13% †0.11% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-196-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
Epic Wholesalers LLC -dba-Epic Peptides Lab
Certificate of Analysis · continued
SS-31 Elamipretide 10 mg Pen · Lot PL-2610-196 · Certificate PL-26-00309
Lot PL-2610-196
Method, peak table and approval

2HPLC method · PL-2610-196-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
0.0955
25.0595

4Peak table

PeakRT (min)AreaArea %
17.90 †—0.03
28.95—99.73
39.80 †—0.13
410.40 †—0.11
Total—100.00
Peaks: 1 unidentified impurity; 2 main peak (SS-31); 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)
640.79 (M+H)+
Deconvoluted Mass
639.75 Da
Theoretical Mass
639.78 Da
Difference
−0.03 Da (47 ppm)
Data File
PL-2610-196-MS.d
Acceptance
Within ± 1.0 Da

6Additional tests

TestPerformed byDateReport / file
Assay vs label claimPrymaLab Analytical2026-10-08—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-08—
Sterility (USP <71>, day-14 read-out)PrymaLab Analytical2026-10-22—
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: 2026-10-22
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-22
M. Phelps
Lab Director · approved for release
Date: 2026-10-22