Certificate PL-26-00018 · Cardiogen 20 mg · lot PL-2609-018
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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-26-00018
Verification key
EP7HQCPR
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Certificate of Analysis · Lot release

Cardiogen 20 mg

Lot PL-2609-018 · Lyophilized powder · Label claim 20 mg/vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-018
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
Cardiogen
Ala-Glu-Asp-Arg (AEDR); Khavinson cardiac peptide bioregulator
CAS number
Not assigned
Molecular formula
C18H31N7O9
Theoretical mass (avg.)
489.5 Da
Sequence
H-AEDR-OH (4 residues; free N- and C-termini)
Purity · RP-HPLC, area %
99.49%
Specification 99.0% • main peak at 4.92 min
Identity · Observed Mass
489.7 Da
Theoretical 489.5 Da • +0.2 Da (408 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 Da489.7 DaPASS
PurityRP-HPLC, UV 214 nm, area%99.0%99.49%PASS
Largest impurityRP-HPLC, area%1.0%0.19% at 5.66 minPASS
Water contentKarl Fischer5.0%1.9%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.06 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: CDG_PL-2609-018_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) Cardiogen (AEDR) — 99.49% @ 4.92 min 0.16% @ 3.85 0.19% @ 5.66 0.16% @ 6.42
Baseline uncropped; main peak and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Cardiogen 20 mg · Lot PL-2609-018 · Certificate PL-26-00018
Lot PL-2609-018
Method, peak table and approval

2HPLC method · CDG_PL-2609-018_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 Cardiogen (AEDR) reference, lot PL-RS-CDG-01, RT 4.90 min

3Gradient program

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

4Peak table

PeakRT (min)AreaArea %
13.856,8800.16
24.924,278,07099.49
35.668,1700.19
46.426,8800.16
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)
490.5 (1+ [M+H]) · 512.5 (1+ [M+Na])
Deconvoluted Mass
489.7 Da
Theoretical Mass
489.5 Da
Difference
+0.2 Da (408 ppm)
Data File
CDG_PL-2609-018_MS_20260919_01
Acceptance
Within ± 1.0 Da

6Additional tests

TestPerformed byDateReport / file
Water contentPrymaLab2026-09-19RPT-KF-PL-2609-018
EndotoxinPrymaLab2026-09-19RPT-ET-PL-2609-018
SterilityPrymaLab2026-09-19RPT-ST-PL-2609-018
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