AX-2026-043228
N-Acetyl Semax Amide · 10 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · lot SGN-2508-K1228
- Report ID
- AX-2026-043228
- Compound
- N-Acetyl Semax Amide
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- SGN — Sangon Biotech (Shanghai) Co., Ltd.
- Batch / lot
- SGN-2508-K1228
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 12 Jan 2026
- Submitted
- 26 Jan 2026
- Quarter
- 2026-Q1
- Submitter
- ph_recon
- 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 | 99.55 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.45 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — Met sulfoxide (+16 Da) | 0.21 | % 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) | 854.3814 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.71 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.32 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.10 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.471 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 94.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.62 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.74 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.93 | % | — | 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 to pale-yellow cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Visible particulates, did not clear | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.66 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 6.55 | min | 6.45 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.96 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 63,709 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs N-acetyl semax free acid (+1 Da) | 1.72 | — | 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 | 6.55 | 4,838,439 | 99.55 | — |
| 2 | Met sulfoxide (+16 Da) | 6.27 | 10,207 | 0.21 | +15.995 |
| 3 | semax (des-acetyl, des-amide, −41 Da) | 6.08 | 5,832 | 0.12 | -41.027 |
| 4 | des-acetyl amide (−42 Da) | 6.22 | 3,402 | 0.07 | -42.011 |
| 5 | N-acetyl semax free acid (+1 Da) | 6.73 | 2,430 | 0.05 | +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 | 428.1980 | 0.0004 | 57.2 |
| 1+ | 855.3879 | 855.3887 | 0.0008 | 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 | 7.62 |
| Counter-ion (acetate) | ion chromatography | 5.74 |
| Residual solvent + inorganic residue | estimated | 0.93 |
| Total peptide content | by difference | 85.71 |
| 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) | 99.67 | 99.55 | divergence +0.15 pp vs batch median |
| Total impurities (% area) | 0.33 | 0.45 | |
| Largest single impurity (% area) | not stated | 0.21 | |
| Water (%) | 6.2 | 7.62 | |
| Counter-ion (%) | not stated | 5.74 | |
| Peptide content (%w/w) | not stated | 85.71 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 11 d) → assay. Submitter did not handle the vial.
- Assay date
- 12 Jan 2026
- Submitted to the index
- 26 Jan 2026
- 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 SGN-2508-K1228 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043229 | SGN-2508-K1228 | VendorInvestigate | 2026-Q1 | 98.90 | 7.29 | 106.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043230 | SGN-2508-K1228 | Janoshik | 2026-Q1 | 99.93 | 7.33 | 93.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043231 | SGN-2508-K1228 | PeptideMeter | 2026-Q1 | 99.48 | 7.57 | 99.0 | Supplier-supplied | 0 | PASS |
| AX-2026-043232 | SGN-2508-K1228 | Medutest | 2026-Q1 | 99.20 | 7.73 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043233 | SGN-2508-K1228 | Janoshik | 2026-Q1 | 99.68 | 8.16 | — | 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-2026-043215 | Afamelanotide | SGN-2602-Y9898 | PeptideMeter | 2026-Q3 | 98.92 | 3.40 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043214 | Afamelanotide | SGN-2602-Y9898 | Janoshik | 2026-Q3 | 99.19 | 3.41 | 106.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043240 | Melanotan II | SGN-2602-L1809 | PeptideMeter | 2026-Q2 | 98.65 | 2.87 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043255 | BPC-157 | SGN-2512-H1950 | Janoshik | 2026-Q2 | 99.06 | 4.99 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043242 | Melanotan II | SGN-2602-L1809 | VendorInvestigate | 2026-Q2 | 98.14 | 2.18 | 107.2 | Buyer-sourced | 1 | FAIL |
| AX-2026-043221 | SLU-PP-332 | SGN-2602-X9969 | Kestrel | 2026-Q2 | 98.70 | 5.87 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043245 | Melanotan II | SGN-2602-L1809 | Janoshik | 2026-Q2 | 98.54 | 2.19 | 100.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043244 | Melanotan II | SGN-2602-L1809 | Janoshik | 2026-Q2 | 99.24 | 2.68 | 98.0 | Supplier-supplied | 1 | MARGINAL |