AX-2025-020538
Semax · 5 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2410-G6492
- Report ID
- AX-2025-020538
- Compound
- Semax
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2410-G6492
- Declared label claim
- 5mg
- Laboratory
- PeptideMeter
- Assay date
- 13 Dec 2024
- Submitted
- 07 Jan 2025
- Quarter
- 2024-Q4
- Submitter
- ro.kimani
- Sample provenance
- Buyer-sourced
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, 28 min gradient, 214 nm | 98.68 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.32 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — Met1 sulfoxide (+16 Da) | 0.73 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 813.3541 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 813.3546 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 84.55 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.43 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.73 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.781 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 10.13 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.61 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.71 | % | — | 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 powder, no defined cake (melt-back) | — | white to off-white intact cake | FAIL |
| 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 | 4.22 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 6.66 | min | 6.63 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.91 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 59,755 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.34 | — | 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 | Semax — main peak | 6.66 | 4,796,154 | 98.68 | — |
| 2 | Met1 sulfoxide (+16 Da) | 6.32 | 35,480 | 0.73 | +15.995 |
| 3 | des-Met (−131 Da) | 6.85 | 14,581 | 0.30 | -131.040 |
| 4 | N-acetyl semax (+42 Da) | 7.05 | 7,290 | 0.15 | +42.011 |
| 5 | diketopiperazine (−18 Da) | 6.81 | 6,804 | 0.14 | -18.011 |
| 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 813.3541 Da, computed from C37H51N9O10S. 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+ | 407.6843 | 407.6846 | 0.0003 | 50.0 |
| 1+ | 814.3614 | 814.3619 | 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 | 10.13 |
| Counter-ion (acetate) | ion chromatography | 4.61 |
| Residual solvent + inorganic residue | estimated | 0.71 |
| Total peptide content | by difference | 84.55 |
| 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) | 98.73 | 98.68 | divergence +0.01 pp vs batch median |
| Total impurities (% area) | 1.27 | 1.32 | |
| Largest single impurity (% area) | 0.49 | 0.73 | |
| Water (%) | not stated | 10.13 | |
| Counter-ion (%) | not stated | 4.61 | |
| Peptide content (%w/w) | 91.7 | 84.55 | |
| 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → third-party forwarder (2 d) → laboratory (courier, cold pack, 4 d) → assay.
- Assay date
- 13 Dec 2024
- Submitted to the index
- 07 Jan 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot SSA-2410-G6492 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020536 | SSA-2410-G6492 | PeptideMeter | 2024-Q4 | 98.42 | 10.19 | 98.3 | Buyer-sourced | 0 | FAIL |
| AX-2025-020537 | SSA-2410-G6492 | Medutest | 2024-Q4 | 97.87 | 9.87 | 98.5 | Buyer-sourced | 0 | FAIL |
| AX-2024-005059 | SSA-2410-G6492 | Janoshik | 2024-Q4 | 98.68 | 9.84 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005060 | SSA-2410-G6492 | Nordanalyt | 2024-Q4 | 99.26 | 9.65 | 97.1 | Supplier-supplied | 0 | PASS |
| AX-2024-005061 | SSA-2410-G6492 | PeptideMeter | 2024-Q4 | 98.97 | 9.39 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005062 | SSA-2410-G6492 | Janoshik | 2024-Q4 | 98.75 | 9.92 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005063 | SSA-2410-G6492 | Janoshik | 2024-Q4 | 98.75 | 10.14 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005064 | SSA-2410-G6492 | Janoshik | 2024-Q4 | 98.92 | 9.66 | 98.5 | Supplier-supplied | 0 | PASS |
| AX-2024-005065 | SSA-2410-G6492 | VendorInvestigate | 2024-Q4 | 98.44 | 10.16 | 96.9 | Buyer-sourced | 0 | FAIL |
Cross-sections
- All Semax records n=216
- All SSA records n=219
- All PeptideMeter records n=1116
- All 2024-Q4 records n=416
- Semax by supplier
- Semax impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042519 | Homopeptide | HOMO-2605-S5227 | Medutest | 2026-Q3 | 99.75 | 5.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042517 | Homopeptide | HOMO-2605-S5227 | Janoshik | 2026-Q3 | 99.92 | 5.88 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042518 | Homopeptide | HOMO-2605-S5227 | Janoshik | 2026-Q3 | 99.76 | 5.61 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042524 | Homopeptide | HOMO-2605-S5227 | Janoshik | 2026-Q3 | 99.93 | 5.75 | 100.9 | Supplier-supplied | 0 | PASS |
| AX-2026-042516 | Homopeptide | HOMO-2605-S5227 | Janoshik | 2026-Q3 | 99.93 | 5.87 | 95.1 | Buyer-sourced | 0 | PASS |
| AX-2026-042522 | Homopeptide | HOMO-2605-S5227 | Nordanalyt | 2026-Q3 | 99.93 | 5.49 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042520 | Homopeptide | HOMO-2605-S5227 | Medutest | 2026-Q3 | 99.93 | 6.12 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042514 | Homopeptide | HOMO-2605-S5227 | Janoshik | 2026-Q3 | 99.59 | 5.48 | 97.0 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043135 | BPC-157 | SSA-2601-N6863 | Nordanalyt | 2026-Q2 | 98.16 | 4.66 | 92.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043160 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.01 | 4.02 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043157 | GHK-Cu | SSA-2604-V7731 | Medutest | 2026-Q2 | 99.19 | 5.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | BPC-157 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.06 | 4.06 | 94.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043154 | GHK-Cu | SSA-2604-V7731 | PeptideMeter | 2026-Q2 | 97.82 | 4.82 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043137 | BPC-157 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 98.17 | 4.14 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043162 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.50 | 4.36 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043134 | BPC-157 | SSA-2601-N6863 | Medutest | 2026-Q2 | 97.89 | 4.01 | — | Buyer-sourced | 1 | FAIL |