AX-2024-005369
L-Glutathione (reduced) · 600 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2312-C7508
- Report ID
- AX-2024-005369
- Compound
- L-Glutathione (reduced)
- Compound class
- Short bioregulator peptides
- Supplier
- PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
- Batch / lot
- PPG-2312-C7508
- Declared label claim
- 600mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 26 May 2024
- Submitted
- 28 May 2024
- Quarter
- 2024-Q2
- Submitter
- c.okafor
- Sample provenance
- Buyer-sourced
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, 15 min gradient, 214 nm | 99.29 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.71 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — S-sulfonate adduct (+80 Da) | 0.32 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 307.0838 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 307.0818 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -6.6 | ppm | ± 20 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.62 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.98 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 630.40 | mg | 600 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 567.234 | mg | 600 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 94.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 8.49 | % | ≤ 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/ | 0.89 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.18 | 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 | Off-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 | 7.27 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 2.12 | min | 2.31 ± 0.20 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.28 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 36,514 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs S-sulfonate adduct (+80 Da) | 1.54 | — | 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 | L-Glutathione (reduced) — main peak | 2.12 | 4,825,802 | 99.29 | — |
| 2 | S-sulfonate adduct (+80 Da) | 2.05 | 15,553 | 0.32 | +79.957 |
| 3 | glutathione disulfide (GSSG, +305 Da) | 2.38 | 12,151 | 0.25 | +304.984 |
| 4 | cysteinyl-glycine (−129 Da) | 2.00 | 4,860 | 0.10 | -129.043 |
| 5 | γ-Glu-Cys (−57 Da) | 2.03 | 1,944 | 0.04 | -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 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 | 308.0891 | -0.0020 | 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 | 8.49 |
| Counter-ion | none expected | 0.00 |
| Residual solvent + inorganic residue | estimated | 0.89 |
| Total peptide content | by difference | 90.62 |
| 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) | 99.27 | 99.29 | divergence -0.19 pp vs batch median |
| Total impurities (% area) | 0.73 | 0.71 | |
| Largest single impurity (% area) | 0.45 | 0.32 | |
| Water (%) | not stated | 8.49 | |
| Counter-ion (%) | 7.4 | N/A | |
| Peptide content (%w/w) | 88.5 | 90.62 | |
| Endotoxin (EU/mg) | not stated | 0.18 | |
| 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
- Domestic warehouse despatch → submitter (2–8 °C, 24 d) → laboratory (courier, cold pack, 4 d) → assay.
- Assay date
- 26 May 2024
- Submitted to the index
- 28 May 2024
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- METHOD LIMITED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot PPG-2312-C7508 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005368 | PPG-2312-C7508 | Janoshik | 2024-Q2 | 99.42 | 8.31 | 101.6 | Buyer-sourced | 0 | FAIL |
| AX-2024-005370 | PPG-2312-C7508 | Janoshik | 2024-Q2 | 99.43 | 8.10 | 104.9 | Buyer-sourced | 0 | PASS |
| AX-2024-005371 | PPG-2312-C7508 | Janoshik | 2024-Q2 | 99.51 | 8.46 | — | Laboratory-retained | 0 | PASS |
| AX-2024-005372 | PPG-2312-C7508 | Janoshik | 2024-Q2 | 99.54 | 8.72 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005373 | PPG-2312-C7508 | Janoshik | 2024-Q2 | 99.46 | 8.62 | — | Laboratory-retained | 0 | PASS |
| AX-2024-005374 | PPG-2312-C7508 | Janoshik | 2024-Q2 | 99.74 | 8.06 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005375 | PPG-2312-C7508 | PeptideMeter | 2024-Q2 | 99.40 | 8.00 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005376 | PPG-2312-C7508 | PeptideMeter | 2024-Q2 | 99.16 | 7.79 | 89.3 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-005377 | PPG-2312-C7508 | PeptideMeter | 2024-Q2 | 99.54 | 8.88 | 104.6 | Buyer-sourced | 0 | PASS |
| AX-2024-005378 | PPG-2312-C7508 | Medutest | 2024-Q2 | 99.88 | 7.64 | 90.1 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043429 | WXT | WXT-2605-B3833 | Nordanalyt | 2026-Q3 | 98.48 | 6.58 | 96.9 | Supplier-supplied | 1 | FAIL |
| AX-2026-043424 | WXT | WXT-2605-B3833 | PeptideMeter | 2026-Q3 | 98.37 | 6.86 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043166 | GL Biochem | GLBI-2606-S7352 | Janoshik | 2026-Q3 | 99.01 | 8.84 | 105.4 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-043423 | WXT | WXT-2605-B3833 | Janoshik | 2026-Q3 | 97.86 | 6.66 | 93.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-043426 | WXT | WXT-2605-B3833 | Kestrel | 2026-Q3 | 98.83 | 6.32 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043425 | WXT | WXT-2605-B3833 | Janoshik | 2026-Q3 | 98.77 | 6.35 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043431 | WXT | WXT-2605-B3833 | Nordanalyt | 2026-Q3 | 97.94 | 6.18 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043427 | WXT | WXT-2605-B3833 | Medutest | 2026-Q3 | 97.67 | 6.08 | — | Buyer-sourced | 1 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043598 | Tesamorelin | PPG-2608-A6835 | Kestrel | 2026-Q3 | 98.91 | 2.56 | 100.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043597 | Tesamorelin | PPG-2608-A6835 | Janoshik | 2026-Q3 | 98.54 | 1.15 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043596 | Tesamorelin | PPG-2608-A6835 | PeptideMeter | 2026-Q3 | 98.74 | 1.83 | 105.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043605 | Retatrutide | PPG-2604-X7060 | Janoshik | 2026-Q2 | 98.17 | 4.29 | 99.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043601 | Retatrutide | PPG-2604-X7060 | Janoshik | 2026-Q2 | 98.28 | 3.96 | 95.3 | Buyer-sourced | 0 | PASS |
| AX-2026-043668 | AOD-9604 | PPG-2602-W8018 | PeptideMeter | 2026-Q2 | 99.47 | 3.06 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043670 | AOD-9604 | PPG-2602-W8018 | PeptideMeter | 2026-Q2 | 99.56 | 2.71 | 104.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043630 | CJC-1295 (no DAC) | PPG-2512-D7211 | Janoshik | 2026-Q2 | 99.66 | 5.11 | 92.5 | Buyer-sourced | 0 | PASS |