AX-2025-020438
Semax · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2502-H5248
- Report ID
- AX-2025-020438
- Compound
- Semax
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2502-H5248
- Declared label claim
- 10mg
- Laboratory
- VendorInvestigate
- Assay date
- 26 Jun 2025
- Submitted
- 08 Jul 2025
- Quarter
- 2025-Q2
- Submitter
- underfill_3to1
- 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, 32 min gradient, 214 nm | 98.29 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 1.71 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — Met1 sulfoxide (+16 Da) | 0.95 | % 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) | 813.3560 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +2.3 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.85 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.36 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.41 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 8.886 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 88.9 | % | 90.0 – 110.0 | FAIL |
| Water content | Karl Fischer, coulometric, duplicate | 5.84 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.84 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.47 | % | — | 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 | Clear after 90 s gentle swirling, no particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.03 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 7.52 | min | 7.49 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.10 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 56,738 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.32 | — | 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 | 7.52 | 4,777,199 | 98.29 | — |
| 2 | Met1 sulfoxide (+16 Da) | 7.14 | 46,173 | 0.95 | +15.995 |
| 3 | N-acetyl semax (+42 Da) | 7.97 | 23,329 | 0.48 | +42.011 |
| 4 | des-Met (−131 Da) | 7.73 | 9,235 | 0.19 | -131.040 |
| 5 | diketopiperazine (−18 Da) | 7.69 | 4,374 | 0.09 | -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 | 407.6853 | 0.0010 | 49.4 |
| 1+ | 814.3614 | 814.3633 | 0.0019 | 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 | 5.84 |
| Counter-ion (acetate) | ion chromatography | 6.84 |
| Residual solvent + inorganic residue | estimated | 0.47 |
| Total peptide content | by difference | 86.85 |
| 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) | 98.77 | 98.29 | divergence -0.06 pp vs batch median |
| Total impurities (% area) | 1.23 | 1.71 | |
| Largest single impurity (% area) | not stated | 0.95 | |
| Water (%) | not stated | 5.84 | |
| Counter-ion (%) | not stated | 6.84 | |
| Peptide content (%w/w) | 91.7 | 86.85 | |
| 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (ambient, 22 d) → laboratory (hand-carried, 4 d) → assay.
- Assay date
- 26 Jun 2025
- Submitted to the index
- 08 Jul 2025
- Laboratory
- VendorInvestigate, Riga, Latvia
- Method basis
- 32 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations 3
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 KP-2502-H5248 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020434 | KP-2502-H5248 | Janoshik | 2025-Q2 | 98.76 | 6.87 | — | Laboratory-retained | 0 | PASS |
| AX-2025-020435 | KP-2502-H5248 | PeptideMeter | 2025-Q2 | 98.80 | 5.96 | 91.3 | Buyer-sourced | 0 | PASS |
| AX-2025-020436 | KP-2502-H5248 | PeptideMeter | 2025-Q2 | 99.32 | 6.50 | — | Supplier-supplied | 0 | PASS |
| AX-2025-020437 | KP-2502-H5248 | Medutest | 2025-Q2 | 99.13 | 6.98 | — | Buyer-sourced | 0 | PASS |
| AX-2025-020439 | KP-2502-H5248 | VendorInvestigate | 2025-Q2 | 98.38 | 6.81 | 103.2 | Buyer-sourced | 0 | FAIL |
| AX-2025-020440 | KP-2502-H5248 | Janoshik | 2025-Q2 | 99.10 | 7.09 | — | Buyer-sourced | 0 | PASS |
| AX-2025-020441 | KP-2502-H5248 | PeptideMeter | 2025-Q2 | 98.86 | 5.90 | — | Laboratory-retained | 0 | PASS |
| AX-2025-020442 | KP-2502-H5248 | Janoshik | 2025-Q2 | 98.64 | 6.54 | — | Buyer-sourced | 0 | PASS |
| AX-2025-020443 | KP-2502-H5248 | Janoshik | 2025-Q2 | 99.04 | 6.59 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| 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-2026-043095 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 95.81 | 5.48 | 105.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043094 | Retatrutide | KP-2607-H5774 | PeptideMeter | 2026-Q3 | 96.32 | 6.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043096 | Retatrutide | KP-2607-H5774 | VendorInvestigate | 2026-Q3 | 96.48 | 6.05 | 104.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043090 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.46 | 5.81 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043091 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.13 | 5.94 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043077 | TB-500 | KP-2605-C5214 | Janoshik | 2026-Q2 | 99.61 | 5.64 | 90.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043093 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.54 | 5.54 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043092 | Retatrutide | KP-2607-H5774 | Medutest | 2026-Q3 | 96.64 | 6.12 | — | Buyer-sourced | 1 | FAIL |