AX-2025-019825
N-Acetyl Semax Amide · 5 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2505-U4985
- Report ID
- AX-2025-019825
- Compound
- N-Acetyl Semax Amide
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- SWB — Shanghai Wibson Biotechnology Co., Ltd.
- Batch / lot
- SWB-2505-U4985
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 18 Jun 2025
- Submitted
- 04 Jul 2025
- Quarter
- 2025-Q2
- Submitter
- c.asante
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the neuroactive and cognitive 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 | 99.78 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.22 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-acetyl amide (−42 Da) | 0.15 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 854.3806 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 854.3832 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +3.0 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.88 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.69 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.37 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.602 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 92.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.98 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.52 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.62 | % | — | 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 | 5.88 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 6.51 | min | 6.45 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.21 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 40,946 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs N-acetyl semax free acid (+1 Da) | 1.39 | — | 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 | N-Acetyl Semax Amide — main peak | 6.51 | 4,849,617 | 99.78 | — |
| 2 | des-acetyl amide (−42 Da) | 6.18 | 7,290 | 0.15 | -42.011 |
| 3 | Met sulfoxide (+16 Da) | 6.23 | 1,944 | 0.04 | +15.995 |
| 4 | N-acetyl semax free acid (+1 Da) | 6.69 | 1,458 | 0.03 | +0.984 |
| 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 854.3806 Da, computed from C39H54N10O10S. 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 (%) |
|---|---|---|---|---|
| 2+ | 428.1976 | 428.1989 | 0.0013 | 49.9 |
| 1+ | 855.3879 | 855.3905 | 0.0026 | 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 | 7.98 |
| Counter-ion (acetate) | ion chromatography | 5.52 |
| Residual solvent + inorganic residue | estimated | 0.62 |
| Total peptide content | by difference | 85.88 |
| 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) | 99.70 | 99.78 | divergence +0.16 pp vs batch median |
| Total impurities (% area) | 0.30 | 0.22 | |
| Largest single impurity (% area) | not stated | 0.15 | |
| Water (%) | 7.1 | 7.98 | |
| Counter-ion (%) | 6.1 | 5.52 | |
| Peptide content (%w/w) | 86.2 | 85.88 | |
| 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, 9 d) → assay. Submitter did not handle the vial.
- Assay date
- 18 Jun 2025
- Submitted to the index
- 04 Jul 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-2505-U4985 n=4
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019826 | SWB-2505-U4985 | Nordanalyt | 2025-Q2 | 99.57 | 8.54 | — | Supplier-supplied | 0 | PASS |
| AX-2025-019827 | SWB-2505-U4985 | Medutest | 2025-Q2 | 99.50 | 8.76 | — | Supplier-supplied | 0 | PASS |
| AX-2025-019828 | SWB-2505-U4985 | Janoshik | 2025-Q2 | 99.14 | 8.02 | — | Supplier-supplied | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043368 | CPC | CPC-2602-D2941 | Medutest | 2026-Q3 | 98.79 | 6.05 | 102.1 | Supplier-supplied | 0 | PASS |
| AX-2026-043574 | BCH | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.75 | 8.85 | 97.9 | Supplier-supplied | 1 | FAIL |
| AX-2026-043575 | BCH | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.44 | 9.19 | 104.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043367 | CPC | CPC-2602-D2941 | Nordanalyt | 2026-Q3 | 99.39 | 6.16 | 92.4 | Supplier-supplied | 0 | PASS |
| AX-2026-043573 | BCH | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.47 | 8.59 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043576 | BCH | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.46 | 9.53 | 92.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-042746 | GGPeps | GGPE-2512-A1206 | PeptideMeter | 2026-Q2 | 98.97 | 6.67 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042234 | Homopeptide | HOMO-2603-C1382 | Janoshik | 2026-Q2 | 98.99 | 8.00 | 99.6 | Supplier-supplied | 0 | PASS |
| 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 |