AX-2026-042829
BPC-157 · 2 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2512-N1746
- Report ID
- AX-2026-042829
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2512-N1746
- Declared label claim
- 2mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 27 Jan 2026
- Submitted
- 03 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- z.moreau
- 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, 35 min gradient, 214 nm | 99.45 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.55 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — acetylated N-terminus (+42 Da) | 0.21 | % 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) | 1418.7056 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -2.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.00 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.53 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.35 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.986 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.84 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 7.54 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.62 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.42 | 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 | White to pale-yellow 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 | 4.50 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 11.05 | min | 11.10 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.04 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 49,836 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs pyroglutamate cyclisation (−17 Da) | 1.78 | — | 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 | 11.05 | 4,833,578 | 99.45 | — |
| 2 | acetylated N-terminus (+42 Da) | 11.61 | 10,207 | 0.21 | +42.011 |
| 3 | BPC-157 arginine-salt artefact | 10.41 | 7,290 | 0.15 | 0.000 |
| 4 | pyroglutamate cyclisation (−17 Da) | 11.41 | 5,346 | 0.11 | -17.027 |
| 5 | des-Gly truncate (−57 Da) | 10.65 | 3,888 | 0.08 | -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.
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 | 473.9091 | -0.0013 | 8.7 |
| 2+ | 710.3619 | 710.3601 | -0.0018 | 50.2 |
| 1+ | 1419.7166 | 1419.7129 | -0.0037 | 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 | 6.84 |
| Counter-ion (acetate) | ion chromatography | 7.54 |
| Residual solvent + inorganic residue | estimated | 0.62 |
| Total peptide content | by difference | 85.00 |
| 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) | 99.78 | 99.45 | divergence +0.35 pp vs batch median |
| Total impurities (% area) | not stated | 0.55 | |
| Largest single impurity (% area) | not stated | 0.21 | |
| Water (%) | 5.8 | 6.84 | |
| Counter-ion (%) | 3.1 | 7.54 | |
| Peptide content (%w/w) | 90.5 | 85.00 | |
| Endotoxin (EU/mg) | not stated | 0.42 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 27 Jan 2026
- Submitted to the index
- 03 Feb 2026
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 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 GGPE-2512-N1746 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042827 | GGPE-2512-N1746 | Medutest | 2026-Q1 | 99.43 | 6.71 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042828 | GGPE-2512-N1746 | VendorInvestigate | 2026-Q1 | 98.82 | 6.86 | 90.7 | Buyer-sourced | 0 | PASS |
| AX-2026-042830 | GGPE-2512-N1746 | Nordanalyt | 2026-Q1 | 99.43 | 6.65 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042831 | GGPE-2512-N1746 | PeptideMeter | 2026-Q1 | 99.48 | 6.94 | 94.4 | Supplier-supplied | 0 | PASS |
| AX-2026-042832 | GGPE-2512-N1746 | Janoshik | 2026-Q1 | 99.65 | 7.00 | 102.7 | Supplier-supplied | 0 | PASS |
| AX-2026-042833 | GGPE-2512-N1746 | Janoshik | 2026-Q1 | 98.61 | 6.41 | 89.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042834 | GGPE-2512-N1746 | Janoshik | 2026-Q1 | 99.13 | 6.93 | 88.6 | Buyer-sourced | 2 | FAIL |
| AX-2026-042835 | GGPE-2512-N1746 | Janoshik | 2026-Q1 | 99.29 | 6.90 | 106.5 | Buyer-sourced | 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-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |