AX-2026-041707
BPC-157 · 10 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-9814
- Report ID
- AX-2026-041707
- Compound
- BPC-157
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- TFS — Thermo Fisher Scientific (China) Co., Ltd.
- Batch / lot
- TFS-{CAT}-9814
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 06 May 2026
- Submitted
- 12 May 2026
- Quarter
- 2026-Q2
- Submitter
- e.rasmussen
- Sample provenance
- Buyer-sourced
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 | 99.29 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.71 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — [D-Val]-diastereomer | 0.46 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1418.7093 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 1418.7167 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.2 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.88 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.26 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.40 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 8.971 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 89.7 | % | 90.0 – 110.0 | FAIL |
| Water content | Karl Fischer, coulometric, duplicate | 4.17 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 8.61 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.34 | % | — | 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 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 | 5.13 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 8.13 | min | 8.14 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.17 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 53,446 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Val]-diastereomer | 0.81 | — | 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 | 8.13 | 4,825,802 | 99.29 | — |
| 2 | [D-Val]-diastereomer | 8.01 | 22,357 | 0.46 | 0.000 |
| 3 | acetylated N-terminus (+42 Da) | 8.53 | 7,290 | 0.15 | +42.011 |
| 4 | pyroglutamate cyclisation (−17 Da) | 8.39 | 3,402 | 0.07 | -17.027 |
| 5 | BPC-157 arginine-salt artefact | 7.67 | 972 | 0.02 | 0.000 |
| 6 | des-Gly truncate (−57 Da) | 7.85 | 486 | 0.01 | -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 | 473.9128 | 0.0024 | 8.2 |
| 2+ | 710.3619 | 710.3656 | 0.0037 | 53.1 |
| 1+ | 1419.7166 | 1419.7240 | 0.0074 | 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 | 4.17 |
| Counter-ion (acetate) | ion chromatography | 8.61 |
| Residual solvent + inorganic residue | estimated | 0.34 |
| Total peptide content | by difference | 86.88 |
| 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) | 99.29 | 99.29 | divergence 0.00 pp vs batch median |
| Total impurities (% area) | 0.71 | 0.71 | |
| Largest single impurity (% area) | not stated | 0.46 | |
| Water (%) | 2.2 | 4.17 | |
| Counter-ion (%) | not stated | 8.61 | |
| Peptide content (%w/w) | not stated | 86.88 | |
| Endotoxin (EU/mg) | 0.39 | 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (−20 °C, 9 d) → laboratory (courier, dry ice, 12 d) → assay.
- Assay date
- 06 May 2026
- Submitted to the index
- 12 May 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations 3
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 TFS-{CAT}-9814 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041702 | TFS-{CAT}-9814 | Medutest | 2026-Q2 | 99.08 | 4.95 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041703 | TFS-{CAT}-9814 | PeptideMeter | 2026-Q2 | 99.35 | 4.03 | 101.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041704 | TFS-{CAT}-9814 | Janoshik | 2026-Q2 | 99.24 | 3.91 | 96.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041705 | TFS-{CAT}-9814 | PeptideMeter | 2026-Q2 | 99.25 | 4.51 | 92.1 | Buyer-sourced | 0 | PASS |
| AX-2026-041706 | TFS-{CAT}-9814 | Janoshik | 2026-Q2 | 99.34 | 5.04 | 94.5 | Buyer-sourced | 0 | PASS |
| AX-2026-041708 | TFS-{CAT}-9814 | Medutest | 2026-Q2 | 99.39 | 4.21 | — | Buyer-sourced | 0 | PASS |
Cross-sections
- All BPC-157 records n=510
- All TFS records n=188
- All Medutest records n=934
- 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-2026-041681 | CJC-1295 with DAC | TFS-{CAT}-9675 | PeptideMeter | 2026-Q3 | 98.82 | 3.67 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041766 | BPC-157 | TFS-{CAT}-1156 | Janoshik | 2026-Q3 | 99.54 | 6.34 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041682 | CJC-1295 with DAC | TFS-{CAT}-9675 | Nordanalyt | 2026-Q3 | 98.94 | 3.24 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041683 | CJC-1295 with DAC | TFS-{CAT}-9675 | Medutest | 2026-Q3 | 98.68 | 3.46 | 97.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041765 | BPC-157 | TFS-{CAT}-1156 | Janoshik | 2026-Q3 | 99.79 | 6.01 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041680 | CJC-1295 with DAC | TFS-{CAT}-9675 | Medutest | 2026-Q3 | 99.18 | 2.85 | 100.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041691 | Semaglutide | TFS-{CAT}-9744 | Janoshik | 2026-Q2 | 98.31 | 6.07 | 91.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041700 | SS-31 (Elamipretide) | TFS-{CAT}-1142 | Medutest | 2026-Q2 | 99.75 | 2.27 | 96.3 | Buyer-sourced | 0 | PASS |