Certificate PL-26-00199 · GKP Blend 70 mg/mL Pen · lot PL-2610-080
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PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00199
Verification key
PF8L2EUT
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Certificate of Analysis · Lot release

GKP Blend 70 mg/mL Pen

Lot PL-2610-080 · Solution · Label claim 70 mg/mL
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-080
Date made
2026-10-02
Date of analysis
2026-10-05
Date issued
2026-10-19
Retest / expiry
2028-10-02
Units in lot / sampled
307 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
GKP Blend
GHK-Cu + KPV + BPC-157 co-lyophilized blend
CAS number
89030-95-5 · 137525-51-0 · 67727-97-3
Molecular formula
—
Theoretical mass (avg.)
401.91 · 1,419.55 · 342.43 Da (GHK-Cu / BPC-157 / KPV)
Composition and sequences
GHK-Cu: GHK-Cu(II) · BPC-157: GEPPPGKPADDAGLV · KPV: KPV
Purity · RP-HPLC, area %
99.52%
Lowest component (BPC-157) • specification ≥ 99.0% for every component
Identity · Components Confirmed
3 / 3
Components confirmed by LC-MS within ± 1.0 Da: 401.90 / 1,419.63 / 342.41 Da
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
GHK-Cu: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.57% · 0.24% · 401.90 DaPASS
BPC-157: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.52% · 0.35% · 1,419.63 DaPASS
KPV: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.71% · 0.19% · 342.41 DaPASS
Assay (total blend)Assay vs label claim66.5–73.5 mg/mL71.12 mg/mLPASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.317 EU/mgPASS
SterilityUSP <71>, 14-dayNo growthNo growthPASS

1HPLC chromatogram

Data file: PL-2610-080-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%3456789101112131415Retention time (min) · stick height = area % (log scale)99.71% · 5.65 min99.57% · 10.64 min99.52% · 12.98 min0.04% †0.06% †0.19% †0.24% †0.02% †0.05% †0.14% †0.35% †0.11% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-080-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot. Area % is per component (each component main peak + its impurities = 100%).
PrymaLab
PrymaLab
Certificate of Analysis · continued
GKP Blend 70 mg/mL Pen · Lot PL-2610-080 · Certificate PL-26-00199
Lot PL-2610-080
Method, peak table and approval

2HPLC method · PL-2610-080-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 %
14.70 †—0.04
25.65—99.71
36.50 †—0.06
47.10 †—0.19
59.30 †—0.24
610.64—99.57
711.40 †—0.02
811.50 †—0.05
912.20 †—0.14
1012.20 †—0.35
1112.98—99.52
1213.90 †—0.11
Total—100.00 per component
Main peaks: 2 KPV · 6 GHK-Cu · 11 BPC-157; all other peaks are the assigned impurities of the neighbouring component · area % within each component (main + impurities = 100% per component) · † nominal reference RT · 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
Deconvoluted Mass
401.90 / 1,419.63 / 342.41 Da
Theoretical Mass
401.91 / 1,419.55 / 342.43 Da
Order
GHK-Cu / BPC-157 / KPV
Difference
−0.01 / +0.08 / −0.02 Da
Data File
PL-2610-080-MS.d
Acceptance
Within ± 1.0 Da (each component)

6Additional tests

TestPerformed byDateReport / file
Assay vs label claimPrymaLab Analytical2026-10-05—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-05—
Sterility (USP <71>, day-14 read-out)PrymaLab Analytical2026-10-19—
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: 2026-10-19
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-19
M. Phelps
Lab Director · approved for release
Date: 2026-10-19