AX-2025-021171
BPC-157 · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2412-Y6192
- Report ID
- AX-2025-021171
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2412-Y6192
- Declared label claim
- 10mg
- Laboratory
- PeptideMeter
- Assay date
- 10 Mar 2025
- Submitted
- 17 Mar 2025
- Quarter
- 2025-Q1
- Submitter
- d.rahimi
- Sample provenance
- Buyer-sourced
Results
Measured against the index acceptance specification for the tissue-repair and immunomodulatory peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | RP-HPLC, 28 min gradient, 214 nm | 98.56 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.44 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — BPC-157 arginine-salt artefact | 0.97 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1418.7093 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1418.7175 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 82.85 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 81.66 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 12.83 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.477 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.97 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 8.66 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.52 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.64 | EU/mg | ≤ 5.0 | PASS |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.73 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 9.22 | min | 9.03 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.03 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 64,615 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Val]-diastereomer | 0.88 | — | no index criterion | REPORTED |
Chromatogram and peak integration
The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | BPC-157 — main peak | 9.22 | 4,790,322 | 98.56 | — |
| 2 | BPC-157 arginine-salt artefact | 8.71 | 47,145 | 0.97 | 0.000 |
| 3 | des-Gly truncate (−57 Da) | 8.90 | 15,067 | 0.31 | -57.021 |
| 4 | [D-Val]-diastereomer | 9.09 | 3,402 | 0.07 | 0.000 |
| 5 | pyroglutamate cyclisation (−17 Da) | 9.51 | 1,944 | 0.04 | -17.027 |
| 6 | truncated (1-12) | 8.32 | 1,458 | 0.03 | -285.132 |
| 7 | acetylated N-terminus (+42 Da) | 9.67 | 972 | 0.02 | +42.011 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.
Mass spectrum and identity
Theoretical monoisotopic mass 1418.7093 Da, computed from C62H98N16O22. All ppm figures on this site are against monoisotopic values — see why that matters.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 3+ | 473.9104 | 473.9131 | 0.0027 | 8.3 |
| 2+ | 710.3619 | 710.3660 | 0.0041 | 56.9 |
| 1+ | 1419.7166 | 1419.7248 | 0.0082 | 100.0 |
Gravimetric mass balance
Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 7.97 |
| Counter-ion (acetate) | ion chromatography | 8.66 |
| Residual solvent + inorganic residue | estimated | 0.52 |
| Total peptide content | by difference | 82.85 |
| Total | 100.00 CLOSES | |
Supplier certificate, as declared
The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 99.90 | 98.56 | divergence +0.36 pp vs batch median |
| Total impurities (% area) | not stated | 1.44 | |
| Largest single impurity (% area) | not stated | 0.97 | |
| Water (%) | not stated | 7.97 | |
| Counter-ion (%) | 4.2 | 8.66 | |
| Peptide content (%w/w) | 91.7 | 82.85 | |
| Endotoxin (EU/mg) | 0.47 | 0.64 | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
Provenance and caveats
Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.
- Sample provenance
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → third-party forwarder (23 d) → laboratory (courier, cold pack, 8 d) → assay.
- Assay date
- 10 Mar 2025
- Submitted to the index
- 17 Mar 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot WXT-2412-Y6192 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021163 | WXT-2412-Y6192 | Medutest | 2025-Q1 | 99.37 | 7.83 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2025-021164 | WXT-2412-Y6192 | PeptideMeter | 2025-Q1 | 99.32 | 8.57 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2025-021165 | WXT-2412-Y6192 | Nordanalyt | 2025-Q1 | 99.93 | 7.99 | 95.9 | Supplier-supplied | 2 | MARGINAL |
| AX-2025-021166 | WXT-2412-Y6192 | Medutest | 2025-Q1 | 99.54 | 8.16 | 89.0 | Supplier-supplied | 3 | MARGINAL |
| AX-2025-021167 | WXT-2412-Y6192 | PeptideMeter | 2025-Q1 | 99.87 | 7.13 | 89.6 | Supplier-supplied | 4 | MARGINAL |
| AX-2025-021168 | WXT-2412-Y6192 | Janoshik | 2025-Q1 | 99.32 | 7.65 | 90.1 | Supplier-supplied | 3 | MARGINAL |
| AX-2025-021169 | WXT-2412-Y6192 | VendorInvestigate | 2025-Q1 | 99.09 | 7.44 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2025-021170 | WXT-2412-Y6192 | Kestrel | 2025-Q1 | 99.93 | 8.04 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-021172 | WXT-2412-Y6192 | Janoshik | 2025-Q1 | 99.58 | 7.27 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-021173 | WXT-2412-Y6192 | Medutest | 2025-Q1 | 99.93 | 7.81 | 99.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2025-021174 | WXT-2412-Y6192 | PeptideMeter | 2025-Q1 | 99.92 | 8.05 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-021175 | WXT-2412-Y6192 | Janoshik | 2025-Q1 | 99.38 | 7.31 | 90.2 | Laboratory-retained | 3 | MARGINAL |
Cross-sections
- All BPC-157 records n=591
- All WXT records n=353
- All PeptideMeter records n=1107
- All 2025-Q1 records n=702
- BPC-157 by supplier
- BPC-157 impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041387 | WWB | WWB-2606-H3906 | Janoshik | 2026-Q3 | 98.95 | 4.64 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-043365 | CPC | CPC-2602-W2646 | Medutest | 2026-Q3 | 98.56 | 2.80 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041385 | WWB | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.31 | 4.31 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043503 | BCH | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.46 | 4.32 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041390 | WWB | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.47 | 4.84 | 99.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041386 | WWB | WWB-2606-H3906 | VendorInvestigate | 2026-Q3 | 99.32 | 4.88 | 99.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041380 | WWB | WWB-2606-H3906 | PeptideMeter | 2026-Q3 | 99.45 | 4.52 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041383 | WWB | WWB-2606-H3906 | PeptideMeter | 2026-Q3 | 99.17 | 4.84 | 91.2 | Supplier-supplied | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043488 | Pramlintide | WXT-2603-D6052 | Janoshik | 2026-Q3 | 97.87 | 4.37 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043406 | Semaglutide | WXT-2604-C4728 | Janoshik | 2026-Q3 | 97.24 | 4.65 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043421 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.15 | 3.09 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043420 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.62 | 3.07 | 96.4 | Supplier-supplied | 0 | PASS |
| AX-2026-043423 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.28 | 3.86 | 98.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043401 | Semaglutide | WXT-2604-C4728 | Medutest | 2026-Q3 | 97.70 | 4.78 | 91.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043400 | Semaglutide | WXT-2604-C4728 | Nordanalyt | 2026-Q3 | 96.86 | 4.11 | 106.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-043422 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.35 | 3.59 | — | Supplier-supplied | 1 | MARGINAL |