AX-2026-042744
BPC-157 · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2602-E1411
- Report ID
- AX-2026-042744
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2602-E1411
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 13 Jun 2026
- Submitted
- 08 Jul 2026
- Quarter
- 2026-Q2
- Submitter
- d.lindholm
- Sample provenance
- Laboratory-retained
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 | 98.89 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.11 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — pyroglutamate cyclisation (−17 Da) | 0.58 | % 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 | 89.55 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.56 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.79 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.441 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.06 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.14 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.25 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.34 | 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 with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 6.31 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.55 | min | 9.62 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.89 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 86,755 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Val]-diastereomer | 1.05 | — | 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 | 9.55 | 4,806,361 | 98.89 | — |
| 2 | pyroglutamate cyclisation (−17 Da) | 9.86 | 28,190 | 0.58 | -17.027 |
| 3 | des-Gly truncate (−57 Da) | 9.21 | 12,637 | 0.26 | -57.021 |
| 4 | truncated (1-12) | 8.59 | 5,346 | 0.11 | -285.132 |
| 5 | [D-Val]-diastereomer | 9.41 | 4,374 | 0.09 | 0.000 |
| 6 | acetylated N-terminus (+42 Da) | 10.03 | 3,402 | 0.07 | +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.
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 | 5.06 |
| Counter-ion (acetate) | ion chromatography | 5.14 |
| Residual solvent + inorganic residue | estimated | 0.25 |
| Total peptide content | by difference | 89.55 |
| 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) | 99.14 | 98.89 | divergence +0.04 pp vs batch median |
| Total impurities (% area) | 0.86 | 1.11 | |
| Largest single impurity (% area) | not stated | 0.58 | |
| Water (%) | not stated | 5.06 | |
| Counter-ion (%) | 2.7 | 5.14 | |
| Peptide content (%w/w) | 97.6 | 89.55 | |
| Endotoxin (EU/mg) | not stated | 0.34 | |
| 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
- Laboratory-retained
- Evidentiary weight
- Provenance documented, selection uncontrolled.
- Chain of custody
- Laboratory retained sample (−20 °C, 13 d since original receipt) → re-assay.
- Assay date
- 13 Jun 2026
- Submitted to the index
- 08 Jul 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 GGPE-2602-E1411 n=4
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042743 | GGPE-2602-E1411 | Janoshik | 2026-Q2 | 98.98 | 4.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042745 | GGPE-2602-E1411 | Janoshik | 2026-Q2 | 99.93 | 4.76 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042746 | GGPE-2602-E1411 | Nordanalyt | 2026-Q2 | 99.21 | 4.20 | — | Buyer-sourced | 0 | PASS |
Cross-sections
- All BPC-157 records n=510
- All GGPeps records n=371
- All Janoshik records n=2989
- All 2026-Q2 records n=1126
- BPC-157 by supplier
- BPC-157 impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043319 | CPC | CPC-2602-W1610 | Medutest | 2026-Q3 | 98.82 | 2.88 | 103.5 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-041766 | TFS | TFS-{CAT}-1156 | Janoshik | 2026-Q3 | 99.54 | 6.34 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043445 | BCH | BCH-2603-G4350 | Nordanalyt | 2026-Q3 | 98.42 | 4.87 | 93.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043440 | BCH | BCH-2603-G4350 | VendorInvestigate | 2026-Q3 | 98.61 | 4.11 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043442 | BCH | BCH-2603-G4350 | Janoshik | 2026-Q3 | 98.65 | 4.78 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043449 | BCH | BCH-2603-G4350 | Kestrel | 2026-Q3 | 99.74 | 4.92 | 91.3 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043448 | BCH | BCH-2603-G4350 | Janoshik | 2026-Q3 | 98.55 | 4.69 | 106.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043318 | CPC | CPC-2602-W1610 | VendorInvestigate | 2026-Q3 | 98.47 | 3.12 | 104.1 | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042784 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Medutest | 2026-Q3 | 98.27 | 4.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042786 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 3.77 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042858 | Selank | GGPE-2603-J2447 | VendorInvestigate | 2026-Q3 | 98.87 | 8.85 | 99.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042783 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 4.45 | 90.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042757 | Melanotan II | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042785 | CJC-1295 (no DAC) | GGPE-2606-E1234 | PeptideMeter | 2026-Q3 | 97.70 | 4.64 | 91.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042756 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042755 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.25 | 6.58 | 90.4 | Buyer-sourced | 0 | PASS |