AX-2025-019918
5-Amino-1MQ · 100 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2501-G5396
- Report ID
- AX-2025-019918
- Compound
- 5-Amino-1MQ
- Compound class
- Non-peptide adjuncts
- Supplier
- SWB — Shanghai Wibson Biotechnology Co., Ltd.
- Batch / lot
- SWB-2501-G5396
- Declared label claim
- 100mg
- Laboratory
- Medutest
- Assay date
- 05 Apr 2025
- Submitted
- 29 Apr 2025
- Quarter
- 2025-Q2
- Submitter
- i.aguirre
- Sample provenance
- Supplier-supplied
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, 25 min gradient, 214 nm | 99.55 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.45 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — free iodide (counter-ion, by IC) | 0.22 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 285.9967 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 285.9962 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -1.9 | ppm | ± 10 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 54.96 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 54.71 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 165.18 | mg | 100 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 90.370 | mg | 100 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.74 | % | ≤ 10.0 | PASS |
| Counter-ion (iodide) | anion-exchange ion chromatography | 38.87 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.43 | % | — | 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 | 3.45 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 4.65 | min | 4.59 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.15 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 66,356 | — | ≥ 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 | 4.65 | 4,838,439 | 99.55 | — |
| 2 | free iodide (counter-ion, by IC) | 4.65 | 10,693 | 0.22 | 0.000 |
| 3 | 1-methylquinolinium (des-amino, −15 Da) | 4.38 | 5,832 | 0.12 | -15.011 |
| 4 | 8-amino regioisomer | 4.83 | 2,916 | 0.06 | 0.000 |
| 5 | 5-nitro-1MQ (unreduced precursor, +30 Da) | 5.22 | 2,430 | 0.05 | +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.
Mass spectrum and identity
Theoretical monoisotopic mass 285.9967 Da, computed from C10H11N2+ · I−. 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+ | 287.0040 | 287.0035 | -0.0005 | 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 | 5.74 |
| Counter-ion (iodide) | ion chromatography | 38.87 |
| Residual solvent + inorganic residue | estimated | 0.43 |
| Total peptide content | by difference | 54.96 |
| 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) | 99.14 | 99.55 | divergence -0.14 pp vs batch median |
| Total impurities (% area) | not stated | 0.45 | |
| Largest single impurity (% area) | not stated | 0.22 | |
| Water (%) | 4.7 | 5.74 | |
| Counter-ion (%) | 4.7 | 38.87 | |
| Peptide content (%w/w) | 90.0 | 54.96 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 2 d) → assay. Submitter did not handle the vial.
- Assay date
- 05 Apr 2025
- Submitted to the index
- 29 Apr 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot SWB-2501-G5396 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019913 | SWB-2501-G5396 | Janoshik | 2025-Q2 | 98.83 | 5.37 | 106.2 | Supplier-supplied | 1 | FAIL |
| AX-2025-019914 | SWB-2501-G5396 | Janoshik | 2025-Q2 | 99.24 | 5.93 | — | Supplier-supplied | 1 | FAIL |
| AX-2025-019915 | SWB-2501-G5396 | Janoshik | 2025-Q2 | 99.38 | 5.76 | 106.1 | Supplier-supplied | 1 | FAIL |
| AX-2025-019916 | SWB-2501-G5396 | Medutest | 2025-Q2 | 99.31 | 5.76 | 98.7 | Supplier-supplied | 1 | FAIL |
| AX-2025-019917 | SWB-2501-G5396 | VendorInvestigate | 2025-Q2 | 98.44 | 5.89 | 96.7 | Laboratory-retained | 1 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042753 | GGPeps | GGPE-2512-M9695 | Medutest | 2026-Q2 | 99.21 | 4.61 | 93.5 | Supplier-supplied | 2 | FAIL |
| AX-2026-042970 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 98.89 | 4.03 | 91.0 | Supplier-supplied | 2 | FAIL |
| AX-2026-042969 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.33 | 3.94 | — | Buyer-sourced | 2 | FAIL |
| AX-2026-042967 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.49 | 4.14 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-042754 | GGPeps | GGPE-2512-M9695 | PeptideMeter | 2026-Q2 | 99.20 | 4.90 | 96.8 | Supplier-supplied | 2 | FAIL |
| AX-2026-042971 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.45 | 4.19 | 107.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042968 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 98.87 | 4.32 | 91.5 | Buyer-sourced | 2 | FAIL |
| AX-2026-042012 | TFC | TFC-2508-L6321 | Janoshik | 2026-Q1 | 99.93 | 5.84 | 95.7 | Supplier-supplied | 0 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042461 | Kisspeptin-10 | SWB-2603-D6238 | Janoshik | 2026-Q3 | 98.35 | 4.65 | 96.5 | Supplier-supplied | 3 | FAIL |
| AX-2026-042479 | Melanotan II | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.16 | 3.67 | 94.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042481 | Melanotan II | SWB-2603-A5707 | Medutest | 2026-Q3 | 98.95 | 3.37 | 90.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042460 | Kisspeptin-10 | SWB-2603-D6238 | Kestrel | 2026-Q3 | 99.55 | 4.21 | 90.8 | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042483 | Melanotan II | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.38 | 3.73 | 107.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042398 | Semaglutide | SWB-2602-X5278 | Nordanalyt | 2026-Q3 | 99.08 | 4.48 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042399 | Semaglutide | SWB-2602-X5278 | Janoshik | 2026-Q3 | 98.56 | 3.82 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042499 | BPC-157 | SWB-2607-Y5787 | Kestrel | 2026-Q3 | 99.93 | 4.25 | 94.4 | Supplier-supplied | 0 | PASS |