Certificate PL-26-00011 · Wolverine Blend (BPC-157 10 mg + TB-500 10 mg) · lot PL-2609-011
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PrymaLab
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Certificate no.
PL-26-00011
Verification key
UJWEQS9S
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Certificate of Analysis · Lot release

Wolverine Blend (BPC-157 10 mg + TB-500 10 mg)

Lot PL-2609-011 · Lyophilized co-blend 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-2609-011
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
Wolverine Blend
BPC-157 + TB-500 co-lyophilized 1:1 blend
CAS number
137525-51-0 · 77591-33-4
Molecular formula
C62H98N16O22 · C212H350N56O78S
Theoretical mass (avg.)
1419.6 · 4963.5 Da (BPC-157 / TB-500 (Thymosin β4))
Composition and sequences
BPC-157 10 mg: H-GEPPPGKPADDAGLV-OH (15 residues; free N- and C-termini) · TB-500 (Thymosin β4) 10 mg: Ac-SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES-OH (43 residues; N-acetyl; free C-terminus)
Purity · RP-HPLC, area %
99.65%
Specification 99.0% (blend, sum of both component peaks)
Identity · Observed Mass
2 / 2
Components confirmed by LC-MS within ± 1.0 Da: 1419.8 / 4963.7 Da
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
AppearanceVisual inspectionWhite to off-white lyophilized powder or cakeWhite lyophilized powderPASS
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da, each component1419.8 Da (BPC-157) · 4963.7 Da (TB-500)PASS
PurityRP-HPLC, UV 214 nm, area%99.0% (blend)99.65%PASS
Largest impurityRP-HPLC, area%1.0%0.16% at 5.34 minPASS
Water contentKarl Fischer5.0%2.0%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.12 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: WLV_PL-2609-011_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) Wolverine Blend — BPC-157 49.68% @ 4.68 min TB-500 49.97% @ 6.08 0.16% @ 5.34 0.12% @ 6.86 0.09% @ 7.58
Baseline uncropped; both component peaks and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Wolverine Blend (BPC-157 10 mg + TB-500 10 mg) · Lot PL-2609-011 · Certificate PL-26-00011
Lot PL-2609-011
Method, peak table and approval

2HPLC method · WLV_PL-2609-011_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 Wolverine blend reference, lot PL-RS-WLV-01, component RTs 4.66 / 6.06 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 (BPC-157)4.682,136,24049.68
25.346,8800.16
3 (TB-500)6.082,148,71049.97
46.865,1600.12
57.583,8700.09
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)
1420.3 (1+ [M+H]) · 1442.2 (1+ [M+Na], BPC-157) · 1241.9 (4+ [M+4H]) · 993.7 (5+ [M+5H], TB-500)
Deconvoluted Mass
1419.8 / 4963.7 Da (by component)
Theoretical Mass
1419.6 / 4963.5 Da (BPC-157 / TB-500)
Difference
≤ +0.2 Da (per component)
Data File
WLV_PL-2609-011_MS_20260919_01
Acceptance
Within ± 1.0 Da (each component)

6Additional tests

TestPerformed byDateReport / file
Water contentPrymaLab2026-09-20RPT-KF-PL-2609-011
EndotoxinPrymaLab2026-09-21RPT-ET-PL-2609-011
SterilityPrymaLab2026-10-02RPT-ST-PL-2609-011
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