AX-2024-004424
Semax · 10 mg declared · GenScript Biotech Corporation · lot GSP-2404-P2784
- Report ID
- AX-2024-004424
- Compound
- Semax
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- GSP — GenScript Biotech Corporation
- Batch / lot
- GSP-2404-P2784
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 07 Jul 2024
- Submitted
- 27 Jul 2024
- Quarter
- 2024-Q3
- Submitter
- diode_array
- 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, 30 min gradient, 214 nm | 99.93 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.07 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-Met (−131 Da) | 0.05 | % 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 | 87.04 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.98 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.60 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.090 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 8.07 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.70 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.19 | % | — | 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 | Off-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 | 5.97 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 7.13 | min | 7.06 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.97 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 72,150 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.47 | — | 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 | 7.13 | 4,856,908 | 99.93 | — |
| 2 | des-Met (−131 Da) | 7.33 | 2,430 | 0.05 | -131.040 |
| 3 | diketopiperazine (−18 Da) | 7.29 | 972 | 0.02 | -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.
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 | 8.07 |
| Counter-ion (acetate) | ion chromatography | 4.70 |
| Residual solvent + inorganic residue | estimated | 0.19 |
| Total peptide content | by difference | 87.04 |
| 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) | 99.87 | 99.93 | divergence -0.06 pp vs batch median |
| Total impurities (% area) | 0.13 | 0.07 | |
| Largest single impurity (% area) | 0.08 | 0.05 | |
| Water (%) | not stated | 8.07 | |
| Counter-ion (%) | not stated | 4.70 | |
| Peptide content (%w/w) | not stated | 87.04 | |
| Endotoxin (EU/mg) | 0.50 | 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, 4 d since original receipt) → re-assay.
- Assay date
- 07 Jul 2024
- Submitted to the index
- 27 Jul 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations 2
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Related records
Same batch — lot GSP-2404-P2784 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004416 | GSP-2404-P2784 | Janoshik | 2024-Q3 | 99.93 | 8.00 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004417 | GSP-2404-P2784 | PeptideMeter | 2024-Q3 | 99.50 | 8.18 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004418 | GSP-2404-P2784 | Janoshik | 2024-Q3 | 99.69 | 7.60 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004419 | GSP-2404-P2784 | Janoshik | 2024-Q3 | 99.93 | 8.17 | — | Supplier-supplied | 0 | PASS |
| AX-2024-004420 | GSP-2404-P2784 | Medutest | 2024-Q3 | 99.93 | 7.98 | 88.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-004421 | GSP-2404-P2784 | PeptideMeter | 2024-Q3 | 99.93 | 9.04 | 97.0 | Laboratory-retained | 0 | PASS |
| AX-2024-004422 | GSP-2404-P2784 | Janoshik | 2024-Q3 | 99.88 | 8.98 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004423 | GSP-2404-P2784 | Medutest | 2024-Q3 | 99.85 | 8.20 | 104.6 | Buyer-sourced | 0 | PASS |
| AX-2024-004425 | GSP-2404-P2784 | Medutest | 2024-Q3 | 99.93 | 7.73 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2024-004426 | GSP-2404-P2784 | PeptideMeter | 2024-Q3 | 99.77 | 8.78 | 93.3 | Buyer-sourced | 0 | PASS |
| AX-2024-004427 | GSP-2404-P2784 | Janoshik | 2024-Q3 | 99.93 | 8.53 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004428 | GSP-2404-P2784 | Medutest | 2024-Q3 | 99.93 | 8.02 | 101.9 | Buyer-sourced | 0 | PASS |
Cross-sections
- All Semax records n=216
- All GSP records n=180
- All Janoshik records n=2989
- All 2024-Q3 records n=464
- 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-2026-041831 | Survodutide | GSP-2603-E3156 | Kestrel | 2026-Q3 | 99.91 | 5.50 | 93.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041836 | Survodutide | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.65 | 5.34 | 90.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041837 | Survodutide | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.33 | 5.37 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041833 | Survodutide | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.08 | 4.91 | 99.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041832 | Survodutide | GSP-2603-E3156 | VendorInvestigate | 2026-Q3 | 98.01 | 5.14 | 99.5 | Buyer-sourced | 0 | PASS |
| AX-2026-041835 | Survodutide | GSP-2603-E3156 | Nordanalyt | 2026-Q3 | 98.34 | 5.74 | 89.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041834 | Survodutide | GSP-2603-E3156 | VendorInvestigate | 2026-Q3 | 97.92 | 5.95 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041838 | Survodutide | GSP-2603-E3156 | PeptideMeter | 2026-Q3 | 98.30 | 5.01 | 102.4 | Buyer-sourced | 0 | PASS |