AX-2025-019041
BPC-157 · 5 mg declared · Guangzhou JEEP Biotechnology Co., Ltd. · lot JEEP-2506-R3035
- Report ID
- AX-2025-019041
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- JEEP — Guangzhou JEEP Biotechnology Co., Ltd.
- Batch / lot
- JEEP-2506-R3035
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 03 Aug 2025
- Submitted
- 25 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- d.radich
- 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, 25 min gradient, 214 nm | 99.53 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.47 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — pyroglutamate cyclisation (−17 Da) | 0.34 | % 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 | 89.89 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.47 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.96 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.332 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 106.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 2.54 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 7.21 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.36 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White cake, partially collapsed | — | white to off-white intact cake | FAIL |
| 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 | 4.71 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 8.03 | min | 8.14 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.08 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 56,620 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Val]-diastereomer | 0.84 | — | 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 | 8.03 | 4,837,467 | 99.53 | — |
| 2 | pyroglutamate cyclisation (−17 Da) | 8.29 | 16,525 | 0.34 | -17.027 |
| 3 | truncated (1-12) | 7.23 | 3,402 | 0.07 | -285.132 |
| 4 | [D-Val]-diastereomer | 7.91 | 1,458 | 0.03 | 0.000 |
| 5 | des-Gly truncate (−57 Da) | 7.75 | 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 | 2.54 |
| Counter-ion (acetate) | ion chromatography | 7.21 |
| Residual solvent + inorganic residue | estimated | 0.36 |
| Total peptide content | by difference | 89.89 |
| 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 | 99.53 | divergence +0.76 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.47 | |
| Largest single impurity (% area) | not stated | 0.34 | |
| Water (%) | 1.0 | 2.54 | |
| Counter-ion (%) | not stated | 7.21 | |
| Peptide content (%w/w) | 94.2 | 89.89 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| 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, 12 d) → assay. Submitter did not handle the vial.
- Assay date
- 03 Aug 2025
- Submitted to the index
- 25 Aug 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot JEEP-2506-R3035 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019036 | JEEP-2506-R3035 | Kestrel | 2025-Q3 | 99.14 | 2.72 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019037 | JEEP-2506-R3035 | Janoshik | 2025-Q3 | 99.02 | 3.48 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019038 | JEEP-2506-R3035 | Janoshik | 2025-Q3 | 98.96 | 3.23 | 105.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019039 | JEEP-2506-R3035 | Janoshik | 2025-Q3 | 98.49 | 3.04 | 102.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019040 | JEEP-2506-R3035 | PeptideMeter | 2025-Q3 | 99.19 | 2.85 | 100.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019042 | JEEP-2506-R3035 | Nordanalyt | 2025-Q3 | 99.31 | 3.26 | — | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| 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-2026-041847 | TB-500 | JEEP-2602-V3434 | Nordanalyt | 2026-Q3 | 99.72 | 3.85 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041886 | Semaglutide | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.19 | 4.03 | 96.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041882 | Semaglutide | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.17 | 4.52 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041845 | TB-500 | JEEP-2602-V3434 | Janoshik | 2026-Q3 | 99.72 | 4.04 | 102.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041921 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.90 | 1.76 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041922 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.41 | 2.60 | 95.7 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041928 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.88 | 1.84 | 92.8 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041849 | TB-500 | JEEP-2602-V3434 | VendorInvestigate | 2026-Q3 | 99.73 | 3.60 | 88.6 | Buyer-sourced | 2 | MARGINAL |