Certificate PL-26-00041 · GKP Blend 70 mg · lot PL-2609-041
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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-26-00041
Verification key
YCC7W5XC
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Certificate of Analysis · Lot release

GKP Blend 70 mg

Lot PL-2609-041 · Lyophilized co-blend powder · Label claim 70 mg/vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-041
Date made
2026-09-17
Date of analysis
2026-09-19
Date issued
2026-10-03
Retest / expiry
2028-09-17
Units in lot / sampled
250 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
GKP Blend
GHK-Cu + KPV + BPC-157 co-lyophilized blend
CAS number
89030-95-5 · 67727-97-3 · 137525-51-0
Molecular formula
C14H22CuN6O4 · C16H30N4O4 · C62H98N16O22
Theoretical mass (avg.)
401.9 · 342.4 · 1419.6 Da (GHK-Cu / KPV / BPC-157)
Composition and sequences
GHK-Cu 50 mg: H-GHK-OH · Cu(II) (1:1 copper complex) · KPV 10 mg: H-KPV-OH (3 residues; free N- and C-termini) · BPC-157 10 mg: H-GEPPPGKPADDAGLV-OH (15 residues; free N- and C-termini)
Purity · RP-HPLC, area %
99.71%
Specification 99.0% • blend purity — sum of the three component peaks
Identity · Observed Mass
3 / 3
Components confirmed by LC-MS within ± 1.0 Da: 402.1 / 342.6 / 1419.8 Da
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
AppearanceVisual inspectionBlue to blue-violet lyophilized cake (GHK-Cu copper complex)Blue lyophilized cakePASS
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da, each component3/3 components confirmedPASS
PurityRP-HPLC, UV 214 nm, area%99.0% (blend)99.71%PASS
Largest impurityRP-HPLC, area%1.0%0.10% at 5.40 minPASS
Water contentKarl Fischer5.0%2.0%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.05 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: GKP_PL-2609-041_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) GKP Blend — GHK-Cu 70.85% @ 2.20 min KPV 12.08% @ 3.31 BPC-157 16.78% @ 4.68 0.10% @ 5.40 0.08% @ 6.15 0.09% @ 7.02
Baseline uncropped; three component peaks and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
GKP Blend 70 mg · Lot PL-2609-041 · Certificate PL-26-00041
Lot PL-2609-041
Method, peak table and approval

2HPLC method · GKP_PL-2609-041_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 (blend)
Blank Injected
Yes
Reference Standard
In-house GKP blend reference, lot PL-RS-GKP-01, component RTs 2.18 / 3.29 / 4.66 min

3Gradient program

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

4Peak table

PeakRT (min)AreaArea %
1 (GHK-Cu)2.203,046,55070.85
2 (KPV)3.31519,44012.08
3 (BPC-157)4.68721,54016.78
45.404,3000.10
56.153,4400.08
67.023,8700.09
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)
402.8 (1+ [M+H], GHK-Cu) · 343.3 (1+ [M+H], KPV) · 1420.3 (1+ [M+H], BPC-157)
Deconvoluted Mass
402.1 / 342.6 / 1419.8 Da (by component)
Theoretical Mass
401.9 / 342.4 / 1419.6 Da (GHK-Cu / KPV / BPC-157)
Difference
≤ +0.2 Da (per component)
Data File
GKP_PL-2609-041_MS_20260919_01
Acceptance
Within ± 1.0 Da (each component)

6Additional tests

TestPerformed byDateReport / file
Water contentPrymaLab2026-09-20RPT-KF-PL-2609-041
EndotoxinPrymaLab2026-09-21RPT-ET-PL-2609-041
SterilityPrymaLab2026-10-02RPT-ST-PL-2609-041
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