AX-2025-021246
L-Glutathione (reduced) · 200 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2508-X6429
FAILMETHOD LIMITED
- Report ID
- AX-2025-021246
- Compound
- L-Glutathione (reduced)
- Compound class
- Short bioregulator peptides
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2508-X6429
- Declared label claim
- 200mg
- Laboratory
- VendorInvestigate
- Assay date
- 03 Aug 2025
- Submitted
- 11 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- d.sorensen
- Sample provenance
- Buyer-sourced
Section 1
Results
Measured against the index acceptance specification for the short bioregulator 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, 32 min gradient, 214 nm | 96.39 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 3.61 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — γ-Glu-Cys (−57 Da) | 2.05 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 307.0838 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 307.0829 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -2.9 | ppm | ± 20 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 93.29 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.92 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 215.19 | mg | 200 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 193.499 | mg | 200 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 96.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.12 | % | ≤ 12.0 | PASS |
| Counter-ion | no ionisable counter-ion expected | N/A | — | not applicable | NOT TESTED |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.59 | % | — | 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 | 6.49 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 4.38 | min | 4.54 ± 0.20 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.86 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 93,892 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs S-sulfonate adduct (+80 Da) | 2.55 | — | 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 | L-Glutathione (reduced) — main peak | 4.38 | 4,684,853 | 96.39 | — |
| 2 | γ-Glu-Cys (−57 Da) | 4.19 | 99,636 | 2.05 | -57.021 |
| 3 | cysteinyl-glycine (−129 Da) | 4.12 | 51,033 | 1.05 | -129.043 |
| 4 | glutathione disulfide (GSSG, +305 Da) | 4.93 | 15,067 | 0.31 | +304.984 |
| 5 | S-sulfonate adduct (+80 Da) | 4.23 | 9,721 | 0.20 | +79.957 |
| 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 3
Mass spectrum and identity
Theoretical monoisotopic mass 307.0838 Da, computed from C10H17N3O6S. 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 (%) |
|---|---|---|---|---|
| 1+ | 308.0911 | 308.0902 | -0.0009 | 100.0 |
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 6.12 |
| Counter-ion | none expected | 0.00 |
| Residual solvent + inorganic residue | estimated | 0.59 |
| Total peptide content | by difference | 93.29 |
| 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) | 97.60 | 96.39 | divergence -0.02 pp vs batch median |
| Total impurities (% area) | 2.40 | 3.61 | |
| Largest single impurity (% area) | not stated | 2.05 | |
| Water (%) | 4.6 | 6.12 | |
| Counter-ion (%) | not stated | N/A | |
| Peptide content (%w/w) | not stated | 93.29 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| 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
- Retail purchase → submitter (ambient, 20 d) → laboratory (courier, cold pack, 8 d) → assay.
- Assay date
- 03 Aug 2025
- Submitted to the index
- 11 Aug 2025
- Laboratory
- VendorInvestigate, Riga, Latvia
- Method basis
- 32 min gradient · high-resolution MS
- Verification status
- METHOD LIMITED
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot BCH-2508-X6429 n=12
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021237 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.90 | 7.07 | — | Supplier-supplied | 0 | FAIL |
| AX-2025-021238 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.98 | 6.01 | — | Supplier-supplied | 1 | FAIL |
| AX-2025-021239 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.56 | 6.21 | 92.1 | Supplier-supplied | 0 | FAIL |
| AX-2025-021240 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.43 | 6.41 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-021241 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 98.01 | 6.65 | 104.9 | Supplier-supplied | 0 | FAIL |
| AX-2025-021242 | BCH-2508-X6429 | Medutest | 2025-Q3 | 97.62 | 6.55 | 97.3 | Buyer-sourced | 0 | FAIL |
| AX-2025-021243 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.38 | 6.17 | — | Supplier-supplied | 0 | FAIL |
| AX-2025-021244 | BCH-2508-X6429 | Medutest | 2025-Q3 | 98.23 | 7.25 | 97.1 | Supplier-supplied | 0 | FAIL |
| AX-2025-021245 | BCH-2508-X6429 | Nordanalyt | 2025-Q3 | 97.62 | 6.54 | 94.2 | Supplier-supplied | 1 | FAIL |
| AX-2025-021247 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.71 | 6.50 | 100.8 | Supplier-supplied | 0 | FAIL |
| AX-2025-021248 | BCH-2508-X6429 | Janoshik | 2025-Q3 | 97.48 | 6.36 | — | Supplier-supplied | 0 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043166 | GL Biochem | GLBI-2606-S7722 | PeptideMeter | 2026-Q3 | 99.26 | 8.52 | 107.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043461 | WXT | WXT-2605-B5313 | PeptideMeter | 2026-Q3 | 97.39 | 6.92 | 102.2 | Supplier-supplied | 0 | FAIL |
| AX-2026-042932 | MKM | MKM-2511-F2902 | Janoshik | 2026-Q2 | 98.57 | 8.41 | 92.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043399 | WXT | WXT-2512-P4300 | PeptideMeter | 2026-Q2 | 98.07 | 8.72 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-042337 | HJ | HJ-2511-F3082 | Janoshik | 2026-Q2 | 99.93 | 7.58 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042930 | MKM | MKM-2511-F2902 | Janoshik | 2026-Q2 | 98.42 | 7.82 | 97.4 | Supplier-supplied | 1 | FAIL |
| AX-2026-042336 | HJ | HJ-2511-F3082 | Janoshik | 2026-Q2 | 99.93 | 7.34 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042338 | HJ | HJ-2511-F3082 | Kestrel | 2026-Q2 | 99.93 | 6.73 | — | Supplier-supplied | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043574 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.75 | 8.85 | 97.9 | Supplier-supplied | 1 | FAIL |
| AX-2026-043503 | BPC-157 | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.46 | 4.32 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043575 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.44 | 9.19 | 104.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043539 | CJC-1295 with DAC | BCH-2607-H7307 | Janoshik | 2026-Q3 | 98.12 | 5.78 | 100.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043504 | BPC-157 | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.38 | 4.45 | 95.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043502 | BPC-157 | BCH-2603-G6422 | PeptideMeter | 2026-Q3 | 97.72 | 4.86 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043501 | BPC-157 | BCH-2603-G6422 | PeptideMeter | 2026-Q3 | 98.37 | 4.75 | 100.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043573 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.47 | 8.59 | — | Supplier-supplied | 1 | FAIL |