AX-2025-018644
N-Acetyl Semax Amide · 10 mg declared · ChinaPeptides Co., Ltd. (QYAOBIO) · lot QYB-2411-G5768
- Report ID
- AX-2025-018644
- Compound
- N-Acetyl Semax Amide
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- QYB — ChinaPeptides Co., Ltd. (QYAOBIO)
- Batch / lot
- QYB-2411-G5768
- Declared label claim
- 10mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 13 Jun 2025
- Submitted
- 14 Jun 2025
- Quarter
- 2025-Q2
- Submitter
- vi.sjoberg
- Sample provenance
- Laboratory-retained
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, 35 min gradient, 214 nm | 99.52 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.48 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-acetyl amide (−42 Da) | 0.31 | % 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 | 83.28 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.88 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.55 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.573 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 10.54 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.88 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.30 | % | — | 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 | 5.58 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 8.73 | min | 8.79 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.00 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 94,437 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs N-acetyl semax free acid (+1 Da) | 2.20 | — | 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 | 8.73 | 4,836,981 | 99.52 | — |
| 2 | des-acetyl amide (−42 Da) | 8.26 | 15,067 | 0.31 | -42.011 |
| 3 | Met sulfoxide (+16 Da) | 8.33 | 3,888 | 0.08 | +15.995 |
| 4 | semax (des-acetyl, des-amide, −41 Da) | 8.08 | 2,916 | 0.06 | -41.027 |
| 5 | N-acetyl semax free acid (+1 Da) | 8.99 | 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.
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 | 10.54 |
| Counter-ion (acetate) | ion chromatography | 5.88 |
| Residual solvent + inorganic residue | estimated | 0.30 |
| Total peptide content | by difference | 83.28 |
| 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) | 99.90 | 99.52 | divergence 0.00 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.48 | |
| Largest single impurity (% area) | not stated | 0.31 | |
| Water (%) | 9.4 | 10.54 | |
| Counter-ion (%) | 9.0 | 5.88 | |
| Peptide content (%w/w) | 81.0 | 83.28 | |
| 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
- Laboratory-retained
- Evidentiary weight
- Provenance documented, selection uncontrolled.
- Chain of custody
- Laboratory retained sample (−20 °C, 31 d since original receipt) → re-assay.
- Assay date
- 13 Jun 2025
- Submitted to the index
- 14 Jun 2025
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot QYB-2411-G5768 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018645 | QYB-2411-G5768 | Janoshik | 2025-Q2 | 99.93 | 8.72 | — | Supplier-supplied | 0 | PASS |
| AX-2025-018646 | QYB-2411-G5768 | Janoshik | 2025-Q2 | 99.34 | 9.46 | 95.9 | Supplier-supplied | 0 | PASS |
| AX-2025-018647 | QYB-2411-G5768 | Medutest | 2025-Q2 | 99.87 | 9.57 | — | Supplier-supplied | 0 | PASS |
| AX-2025-018648 | QYB-2411-G5768 | PeptideMeter | 2025-Q2 | 99.93 | 10.00 | 90.8 | Supplier-supplied | 0 | PASS |
| AX-2025-018649 | QYB-2411-G5768 | PeptideMeter | 2025-Q2 | 99.93 | 9.62 | — | 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-2026-041453 | Retatrutide | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 98.02 | 2.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041454 | Retatrutide | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.84 | 2.77 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041538 | Retatrutide | QYB-2602-G6308 | Medutest | 2026-Q3 | 98.50 | 2.85 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041456 | Retatrutide | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.23 | 3.24 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041452 | Retatrutide | QYB-2604-B5660 | Nordanalyt | 2026-Q3 | 98.50 | 3.36 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041427 | Ipamorelin | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 4.12 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041488 | PT-141 (Bremelanotide) | QYB-2607-L5615 | Janoshik | 2026-Q3 | 99.93 | 3.79 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041459 | Retatrutide | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 97.91 | 2.84 | 92.2 | Buyer-sourced | 1 | MARGINAL |