AX-2026-043391
BPC-157 · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2603-K3648
FAILVERIFIED
- Report ID
- AX-2026-043391
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2603-K3648
- Declared label claim
- 5mg
- Laboratory
- PeptideMeter
- Assay date
- 24 Jun 2026
- Submitted
- 02 Jul 2026
- Quarter
- 2026-Q2
- Submitter
- esi_tof
- Sample provenance
- Buyer-sourced
Section 1
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 | 97.64 | % area | ≥ 98.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.36 | % area | ≤ 2.0 | FAIL |
| Largest single impurity | RP-HPLC — [D-Val]-diastereomer | 1.46 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1418.7093 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1418.7060 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -2.3 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.31 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.30 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 6.31 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.256 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.14 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 8.55 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 1.00 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.45 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | Off-white lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.88 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 9.17 | min | 9.03 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.99 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 38,651 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Val]-diastereomer | 0.68 | — | no index criterion | REPORTED |
Section 2
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 | 9.17 | 4,745,607 | 97.64 | — |
| 2 | [D-Val]-diastereomer | 9.04 | 70,961 | 1.46 | 0.000 |
| 3 | pyroglutamate cyclisation (−17 Da) | 9.46 | 27,218 | 0.56 | -17.027 |
| 4 | truncated (1-12) | 8.27 | 7,776 | 0.16 | -285.132 |
| 5 | BPC-157 arginine-salt artefact | 8.66 | 5,832 | 0.12 | 0.000 |
| 6 | acetylated N-terminus (+42 Da) | 9.62 | 1,458 | 0.03 | +42.011 |
| 7 | des-Gly truncate (−57 Da) | 8.85 | 1,458 | 0.03 | -57.021 |
| 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.
Section 3
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 | 473.9093 | -0.0011 | 8.2 |
| 2+ | 710.3619 | 710.3603 | -0.0016 | 56.8 |
| 1+ | 1419.7166 | 1419.7133 | -0.0033 | 100.0 |
Section 4
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 | 5.14 |
| Counter-ion (acetate) | ion chromatography | 8.55 |
| Residual solvent + inorganic residue | estimated | 1.00 |
| Total peptide content | by difference | 85.31 |
| 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) | 98.07 | 97.64 | divergence +0.43 pp vs batch median |
| Total impurities (% area) | 1.93 | 2.36 | |
| Largest single impurity (% area) | not stated | 1.46 | |
| Water (%) | not stated | 5.14 | |
| Counter-ion (%) | not stated | 8.55 | |
| Peptide content (%w/w) | not stated | 85.31 | |
| Endotoxin (EU/mg) | not stated | 0.45 | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
Section 5
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 (21 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 24 Jun 2026
- Submitted to the index
- 02 Jul 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot WXT-2603-K3648 n=5
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043390 | WXT-2603-K3648 | VendorInvestigate | 2026-Q2 | 97.74 | 4.42 | 96.8 | Buyer-sourced | 1 | FAIL |
| AX-2026-043392 | WXT-2603-K3648 | Janoshik | 2026-Q2 | 97.56 | 4.79 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043393 | WXT-2603-K3648 | PeptideMeter | 2026-Q2 | 97.38 | 4.24 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043394 | WXT-2603-K3648 | PeptideMeter | 2026-Q2 | 98.13 | 4.67 | — | Supplier-supplied | 1 | MARGINAL |
Cross-sections
- All BPC-157 records n=591
- All WXT records n=353
- All PeptideMeter records n=1107
- All 2026-Q2 records n=1009
- 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 |