Lowest component (TB-500) • specification ≥ 99.0% for every component
Identity · Components Confirmed
2 / 2
Components confirmed by LC-MS within ± 1.0 Da: 1,419.57 / 4,963.47 Da
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
BPC-157: purity · largest impurity · mass
RP-HPLC 214 nm (area%); LC-MS, ESI+
≥ 99.0% · ≤ 1.0% · ± 1.0 Da
99.63% · 0.21% · 1,419.57 Da
PASS
TB-500: purity · largest impurity · mass
RP-HPLC 214 nm (area%); LC-MS, ESI+
≥ 99.0% · ≤ 1.0% · ± 1.0 Da
99.38% · 0.24% · 4,963.47 Da
PASS
Assay (total blend)
Assay vs label claim
19–21 mg/mL
20.49 mg/mL
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.429 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-026-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-026-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%).
Main peaks: 3 BPC-157 · 7 TB-500; 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
1,419.57 / 4,963.47 Da
Theoretical Mass
1,419.55 / 4,963.44 Da
Order
BPC-157 / TB-500
Difference
+0.02 / +0.03 Da
Data File
PL-2610-026-MS.d
Acceptance
Within ± 1.0 Da (each component)
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
PrymaLab Analytical
2026-10-02
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-02
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-16
—
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