PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00011
Verification key
UJWEQS9S
Scan or enter both at
prymalab.net/testing/verify
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 PrymaLabIn-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-011
Date of analysis
2026-09-19
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
| Test | Method | Specification | Result | Conclusion |
| Appearance | Visual inspection | White to off-white lyophilized powder or cake | White lyophilized powder | PASS |
| Identity (mass) | LC-MS, ESI positive | Theoretical ± 1.0 Da, each component | 1419.8 Da (BPC-157) · 4963.7 Da (TB-500) | PASS |
| Purity | RP-HPLC, UV 214 nm, area% | 99.0% (blend) | 99.65% | PASS |
| Largest impurity | RP-HPLC, area% | 1.0% | 0.16% at 5.34 min | PASS |
| Water content | Karl Fischer | 5.0% | 2.0% | PASS |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.12 EU/mg | PASS |
| Sterility / bioburden | USP <71>, membrane filtration | No growth after 14 days | No growth; conforms | PASS |
1HPLC chromatogram
Data file: WLV_PL-2609-011_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
Baseline uncropped; both component peaks and impurities labeled with retention times. Peak table on page 2.
2HPLC method · WLV_PL-2609-011_20260919_01
Instrument
Waters Alliance e2695, SN E2695B742
Data System
Empower 3, Build 3471
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
Sample Diluent
Water, 0.1% TFA
Sample Concentration
0.5 mg/mL (blend)
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 |
| 0.0 | 95 | 5 |
| 3.0 | 95 | 5 |
| 7.0 | 55 | 45 |
| 8.0 | 20 | 80 |
| 9.0 | 20 | 80 |
| 10.0 | 95 | 5 |
4Peak table
| Peak | RT (min) | Area | Area % |
| 1 (BPC-157) | 4.68 | 2,136,240 | 49.68 |
| 2 | 5.34 | 6,880 | 0.16 |
| 3 (TB-500) | 6.08 | 2,148,710 | 49.97 |
| 4 | 6.86 | 5,160 | 0.12 |
| 5 | 7.58 | 3,870 | 0.09 |
| Total | | 4,300,000 | 100.00 |
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
| Test | Performed by | Date | Report / file |
| Water content | PrymaLab | 2026-09-20 | RPT-KF-PL-2609-011 |
| Endotoxin | PrymaLab | 2026-09-21 | RPT-ET-PL-2609-011 |
| Sterility | PrymaLab | 2026-10-02 | RPT-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