AX-2025-020111
5-Amino-1MQ · 50 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2507-E8786
- Report ID
- AX-2025-020111
- Compound
- 5-Amino-1MQ
- Compound class
- Non-peptide adjuncts
- Supplier
- SWB — Shanghai Wibson Biotechnology Co., Ltd.
- Batch / lot
- SWB-2507-E8786
- Declared label claim
- 50mg
- Laboratory
- Janoshik Analytical
- Assay date
- 07 Sep 2025
- Submitted
- 30 Sep 2025
- Quarter
- 2025-Q3
- Submitter
- z.kowalski
- Sample provenance
- Buyer-sourced
Results
Measured against the index acceptance specification for the non-peptide adjuncts 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 | 99.57 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.43 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — 8-amino regioisomer | 0.15 | % 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 | 46.57 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 46.37 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 99.30 | mg | 50 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 46.045 | mg | 50 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 92.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.10 | % | ≤ 10.0 | PASS |
| Counter-ion (iodide) | anion-exchange ion chromatography | 46.87 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.46 | % | — | 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 | 5.12 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 5.52 | min | 5.42 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.93 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 72,335 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free iodide (counter-ion, by IC) | 0.00 | — | 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 | 5-Amino-1MQ — main peak | 5.52 | 4,839,411 | 99.57 | — |
| 2 | 8-amino regioisomer | 5.74 | 7,290 | 0.15 | 0.000 |
| 3 | free iodide (counter-ion, by IC) | 5.52 | 5,346 | 0.11 | 0.000 |
| 4 | 1-methylquinolinium (des-amino, −15 Da) | 5.20 | 4,860 | 0.10 | -15.011 |
| 5 | 5-nitro-1MQ (unreduced precursor, +30 Da) | 6.20 | 3,402 | 0.07 | +29.974 |
| 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 | 6.10 |
| Counter-ion (iodide) | ion chromatography | 46.87 |
| Residual solvent + inorganic residue | estimated | 0.46 |
| Total peptide content | by difference | 46.57 |
| 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) | 99.5 | 99.57 | divergence +0.18 pp vs batch median |
| Total impurities (% area) | not stated | 0.43 | |
| Largest single impurity (% area) | not stated | 0.15 | |
| Water (%) | 5.7 | 6.10 | |
| Counter-ion (%) | 5.0 | 46.87 | |
| Peptide content (%w/w) | 88.7 | 46.57 | |
| Endotoxin (EU/mg) | not stated | 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 (2–8 °C, 25 d) → laboratory (courier, ambient, 11 d) → assay.
- Assay date
- 07 Sep 2025
- Submitted to the index
- 30 Sep 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations 5
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 SWB-2507-E8786 n=12
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020102 | SWB-2507-E8786 | Kestrel | 2025-Q3 | 99.22 | 6.37 | 100.3 | Buyer-sourced | 1 | FAIL |
| AX-2025-020103 | SWB-2507-E8786 | PeptideMeter | 2025-Q3 | 99.61 | 6.08 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-020104 | SWB-2507-E8786 | PeptideMeter | 2025-Q3 | 99.24 | 6.06 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-020105 | SWB-2507-E8786 | VendorInvestigate | 2025-Q3 | 98.76 | 5.96 | 99.4 | Buyer-sourced | 1 | FAIL |
| AX-2025-020106 | SWB-2507-E8786 | Janoshik | 2025-Q3 | 99.34 | 6.38 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-020107 | SWB-2507-E8786 | Janoshik | 2025-Q3 | 99.29 | 6.10 | 106.7 | Buyer-sourced | 1 | FAIL |
| AX-2025-020108 | SWB-2507-E8786 | Medutest | 2025-Q3 | 99.17 | 5.71 | 105.1 | Laboratory-retained | 2 | FAIL |
| AX-2025-020109 | SWB-2507-E8786 | Janoshik | 2025-Q3 | 99.38 | 5.62 | 101.8 | Buyer-sourced | 1 | FAIL |
| AX-2025-020110 | SWB-2507-E8786 | Kestrel | 2025-Q3 | 99.93 | 5.96 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-020112 | SWB-2507-E8786 | PeptideMeter | 2025-Q3 | 99.26 | 6.60 | 100.4 | Buyer-sourced | 1 | FAIL |
| AX-2025-020113 | SWB-2507-E8786 | Janoshik | 2025-Q3 | 99.51 | 6.09 | 92.0 | Buyer-sourced | 1 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043050 | KP | KP-2511-W5347 | Janoshik | 2026-Q2 | 99.35 | 4.16 | 105.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-043044 | KP | KP-2511-W5347 | PeptideMeter | 2026-Q2 | 99.61 | 4.15 | 90.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043052 | KP | KP-2511-W5347 | Medutest | 2026-Q2 | 99.45 | 4.23 | 105.5 | Buyer-sourced | 1 | FAIL |
| AX-2026-043045 | KP | KP-2511-W5347 | Janoshik | 2026-Q2 | 99.47 | 4.08 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043043 | KP | KP-2511-W5347 | Janoshik | 2026-Q2 | 99.58 | 4.16 | 101.1 | Buyer-sourced | 0 | FAIL |
| AX-2026-042869 | GGPeps | GGPE-2512-M2434 | Kestrel | 2026-Q2 | 99.55 | 4.65 | 103.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-042868 | GGPeps | GGPE-2512-M2434 | PeptideMeter | 2026-Q2 | 99.32 | 4.39 | 88.5 | Buyer-sourced | 1 | FAIL |
| AX-2026-043047 | KP | KP-2511-W5347 | Janoshik | 2026-Q2 | 99.68 | 4.17 | 104.0 | Supplier-supplied | 0 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042637 | Semaglutide | SWB-2602-X7905 | Janoshik | 2026-Q3 | 98.37 | 4.26 | 102.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042645 | Semaglutide | SWB-2602-X7905 | Medutest | 2026-Q3 | 98.48 | 4.52 | 95.2 | Buyer-sourced | 0 | PASS |
| AX-2026-042642 | Semaglutide | SWB-2602-X7905 | PeptideMeter | 2026-Q3 | 97.96 | 4.48 | 90.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042640 | Semaglutide | SWB-2602-X7905 | PeptideMeter | 2026-Q3 | 98.55 | 4.29 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042638 | Semaglutide | SWB-2602-X7905 | Janoshik | 2026-Q3 | 98.74 | 3.65 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042639 | Semaglutide | SWB-2602-X7905 | Janoshik | 2026-Q3 | 98.77 | 4.21 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042641 | Semaglutide | SWB-2602-X7905 | Janoshik | 2026-Q3 | 98.86 | 4.48 | 99.1 | Buyer-sourced | 0 | PASS |
| AX-2026-042644 | Semaglutide | SWB-2602-X7905 | PeptideMeter | 2026-Q3 | 98.76 | 3.57 | 97.7 | Buyer-sourced | 0 | PASS |