AX-2026-043639
BPC-157 · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2508-E6361
- Report ID
- AX-2026-043639
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2508-E6361
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 30 Jan 2026
- Submitted
- 20 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- Contributor #W-3218
- Sample provenance
- Supplier-supplied
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, 30 min gradient, 214 nm | 98.82 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.18 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — pyroglutamate cyclisation (−17 Da) | 0.67 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 88.74 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.69 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.03 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.672 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 96.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.23 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.60 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.43 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.58 | 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 | 5.15 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.74 | min | 9.62 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.20 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 52,242 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs pyroglutamate cyclisation (−17 Da) | 1.77 | — | 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 | 9.74 | 4,802,958 | 98.82 | — |
| 2 | pyroglutamate cyclisation (−17 Da) | 10.05 | 32,564 | 0.67 | -17.027 |
| 3 | acetylated N-terminus (+42 Da) | 10.22 | 13,123 | 0.27 | +42.011 |
| 4 | truncated (1-12) | 8.78 | 7,776 | 0.16 | -285.132 |
| 5 | BPC-157 arginine-salt artefact | 9.19 | 2,430 | 0.05 | 0.000 |
| 6 | des-Gly truncate (−57 Da) | 9.40 | 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.
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 | 4.23 |
| Counter-ion (acetate) | ion chromatography | 6.60 |
| Residual solvent + inorganic residue | estimated | 0.43 |
| Total peptide content | by difference | 88.74 |
| 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) | 98.10 | 98.82 | divergence +0.04 pp vs batch median |
| Total impurities (% area) | not stated | 1.18 | |
| Largest single impurity (% area) | not stated | 0.67 | |
| Water (%) | 2.9 | 4.23 | |
| Counter-ion (%) | 7.4 | 6.60 | |
| Peptide content (%w/w) | 89.1 | 88.74 | |
| Endotoxin (EU/mg) | not stated | 0.58 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 6 d) → assay. Submitter did not handle the vial.
- Assay date
- 30 Jan 2026
- Submitted to the index
- 20 Feb 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations 1
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Related records
Same batch — lot WXT-2508-E6361 n=5
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043636 | WXT-2508-E6361 | Janoshik | 2026-Q1 | 97.95 | 3.50 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043637 | WXT-2508-E6361 | PeptideMeter | 2026-Q1 | 98.06 | 4.56 | 96.4 | Buyer-sourced | 1 | FAIL |
| AX-2026-043638 | WXT-2508-E6361 | Janoshik | 2026-Q1 | 98.53 | 4.28 | 106.1 | Supplier-supplied | 0 | PASS |
| AX-2026-043640 | WXT-2508-E6361 | Janoshik | 2026-Q1 | 98.05 | 3.54 | 96.5 | Buyer-sourced | 0 | PASS |
Cross-sections
- All BPC-157 records n=590
- All WXT records n=380
- All Janoshik records n=3300
- All 2026-Q1 records n=895
- BPC-157 by supplier
- BPC-157 impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043691 | BCH | BCH-2603-L7768 | Janoshik | 2026-Q3 | 98.66 | 5.12 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043493 | CPC | CPC-2602-W3201 | Janoshik | 2026-Q3 | 98.76 | 2.27 | — | Buyer-sourced | 2 | FAIL |
| AX-2026-041387 | WWB | WWB-2606-H3906 | Janoshik | 2026-Q3 | 99.33 | 4.64 | — | Laboratory-retained | 0 | PASS |
| AX-2026-043693 | BCH | BCH-2603-L7768 | PeptideMeter | 2026-Q3 | 97.82 | 5.21 | 94.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043686 | BCH | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.64 | 5.27 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043695 | BCH | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.61 | 5.42 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043487 | CPC | CPC-2602-W3201 | VendorInvestigate | 2026-Q3 | 99.07 | 2.76 | 97.0 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-041385 | WWB | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.29 | 4.43 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043651 | Pramlintide | WXT-2603-D6459 | PeptideMeter | 2026-Q3 | 98.21 | 4.97 | 101.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043531 | Leuprolide | WXT-2604-K4483 | Medutest | 2026-Q3 | 99.00 | 5.03 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043561 | Semaglutide | WXT-2604-C5135 | Janoshik | 2026-Q3 | 96.96 | 4.22 | 91.3 | Buyer-sourced | 0 | FAIL |
| AX-2026-043627 | L-Glutathione (reduced) | WXT-2605-B5720 | Janoshik | 2026-Q3 | 97.96 | 6.08 | 92.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043564 | Semaglutide | WXT-2604-C5135 | Janoshik | 2026-Q3 | 97.15 | 4.44 | 104.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043533 | Leuprolide | WXT-2604-K4483 | PeptideMeter | 2026-Q3 | 99.89 | 4.94 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043624 | L-Glutathione (reduced) | WXT-2605-B5720 | Nordanalyt | 2026-Q3 | 98.18 | 6.95 | 105.3 | Buyer-sourced | 2 | FAIL |
| AX-2026-043556 | Semaglutide | WXT-2604-C5135 | PeptideMeter | 2026-Q3 | 97.56 | 4.35 | 89.6 | Buyer-sourced | 1 | MARGINAL |