The gap between 97.91 % and the class specification should be read against an expanded uncertainty of roughly ±0.5 pp. A shortfall inside that band is not a finding; a shortfall well outside it is.
AX-2026-043143
BPC-157 · 2 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2601-N6863
FAILPURITY ONLY
- Report ID
- AX-2026-043143
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2601-N6863
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 01 May 2026
- Submitted
- 19 May 2026
- Quarter
- 2026-Q2
- Submitter
- ja.cabrera
- 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, 30 min gradient, 214 nm | 97.91 | % area | ≥ 98.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.09 | % area | ≤ 2.0 | FAIL |
| Largest single impurity | RP-HPLC — pyroglutamate cyclisation (−17 Da) | 1.29 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 5.02 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.56 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.63 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.30 | 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 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 | 4.45 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.67 | min | 9.62 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.09 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 63,521 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Val]-diastereomer | 0.89 | — | 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 | 9.67 | 4,758,730 | 97.91 | — |
| 2 | pyroglutamate cyclisation (−17 Da) | 9.98 | 62,698 | 1.29 | -17.027 |
| 3 | des-Gly truncate (−57 Da) | 9.33 | 25,274 | 0.52 | -57.021 |
| 4 | acetylated N-terminus (+42 Da) | 10.15 | 7,290 | 0.15 | +42.011 |
| 5 | [D-Val]-diastereomer | 9.53 | 2,916 | 0.06 | 0.000 |
| 6 | BPC-157 arginine-salt artefact | 9.12 | 1,944 | 0.04 | 0.000 |
| 7 | truncated (1-12) | 8.71 | 1,458 | 0.03 | -285.132 |
| 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 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.
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) | 97.5 | 97.91 | divergence -0.53 pp vs batch median |
| Total impurities (% area) | not stated | 2.09 | |
| Largest single impurity (% area) | not stated | 1.29 | |
| Water (%) | 3.6 | 5.02 | |
| Counter-ion (%) | 8.3 | 6.56 | |
| Peptide content (%w/w) | 87.5 | not determined | |
| Endotoxin (EU/mg) | 0.47 | 0.30 | |
| 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
- Domestic warehouse despatch → submitter (2–8 °C, 11 d) → laboratory (courier, cold pack, 5 d) → assay.
- Assay date
- 01 May 2026
- Submitted to the index
- 19 May 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 4
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.
Declared figure and measured figure on this lot agree within measurement repeatability. Whatever the rounding convention is doing, it is not moving the number away from the material.
Under a quality system a result field and a specification field are different controlled fields, and conflating them is a document-control observation. It is also one of the easiest things in this whole market to fix.
The certificate that arrives with a retail order is the certificate an ordinary buyer gets. Assessing it is assessing the real documentation practice rather than the sample-request one.
Section 7
Related records
Same batch — lot SSA-2601-N6863 n=15
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043130 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 97.57 | 4.69 | 100.4 | Buyer-sourced | 1 | FAIL |
| AX-2026-043131 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 97.75 | 4.43 | 100.0 | Buyer-sourced | 1 | FAIL |
| AX-2026-043132 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.03 | 4.34 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043133 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.37 | 4.34 | 106.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043134 | SSA-2601-N6863 | Medutest | 2026-Q2 | 97.89 | 4.01 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043135 | SSA-2601-N6863 | Nordanalyt | 2026-Q2 | 98.16 | 4.66 | 92.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043136 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.52 | 4.02 | 92.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043137 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 98.17 | 4.14 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043138 | SSA-2601-N6863 | VendorInvestigate | 2026-Q2 | 97.99 | 4.20 | 90.1 | Buyer-sourced | 1 | FAIL |
| AX-2026-043139 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 97.78 | 4.67 | 99.8 | Buyer-sourced | 1 | FAIL |
| AX-2026-043140 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 97.86 | 4.85 | 105.9 | Buyer-sourced | 1 | FAIL |
| AX-2026-043141 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.06 | 4.06 | 94.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043142 | SSA-2601-N6863 | Medutest | 2026-Q2 | 98.19 | 4.83 | 95.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043144 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.08 | 4.74 | — | Buyer-sourced | 1 | MARGINAL |
Cross-sections
- All BPC-157 records n=510
- All SSA records n=219
- 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-2026-043135 | BPC-157 | SSA-2601-N6863 | Nordanalyt | 2026-Q2 | 98.16 | 4.66 | 92.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043160 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.01 | 4.02 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043157 | GHK-Cu | SSA-2604-V7731 | Medutest | 2026-Q2 | 99.19 | 5.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | BPC-157 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.06 | 4.06 | 94.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043154 | GHK-Cu | SSA-2604-V7731 | PeptideMeter | 2026-Q2 | 97.82 | 4.82 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043137 | BPC-157 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 98.17 | 4.14 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043162 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.50 | 4.36 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043134 | BPC-157 | SSA-2601-N6863 | Medutest | 2026-Q2 | 97.89 | 4.01 | — | Buyer-sourced | 1 | FAIL |