AX-2026-042907
Semax · 20 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2512-B2992
- Report ID
- AX-2026-042907
- Compound
- Semax
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- MKM — Xi'an Mokemei Biotechnology Co., Ltd.
- Batch / lot
- MKM-2512-B2992
- Declared label claim
- 20mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 02 May 2026
- Submitted
- 10 May 2026
- Quarter
- 2026-Q2
- Submitter
- l.rahimi
- 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, 15 min gradient, 214 nm | 99.35 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.65 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — Met1 sulfoxide (+16 Da) | 0.46 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 813.3541 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 813.3591 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +6.1 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.47 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.91 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 21.14 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 18.161 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.61 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.98 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.94 | % | — | 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 | 5.21 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 3.61 | min | 3.81 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.04 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 76,786 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.50 | — | 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 | 3.61 | 4,828,718 | 99.35 | — |
| 2 | Met1 sulfoxide (+16 Da) | 3.43 | 22,357 | 0.46 | +15.995 |
| 3 | diketopiperazine (−18 Da) | 3.69 | 5,832 | 0.12 | -18.011 |
| 4 | N-acetyl semax (+42 Da) | 3.82 | 1,944 | 0.04 | +42.011 |
| 5 | des-Met (−131 Da) | 3.71 | 1,458 | 0.03 | -131.040 |
| 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 | 407.6868 | 0.0025 | 57.9 |
| 1+ | 814.3614 | 814.3664 | 0.0050 | 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 | 6.61 |
| Counter-ion (acetate) | ion chromatography | 5.98 |
| Residual solvent + inorganic residue | estimated | 0.94 |
| Total peptide content | by difference | 86.47 |
| 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) | 99.07 | 99.35 | divergence +0.50 pp vs batch median |
| Total impurities (% area) | 0.93 | 0.65 | |
| Largest single impurity (% area) | 0.51 | 0.46 | |
| Water (%) | 5.2 | 6.61 | |
| Counter-ion (%) | 6.7 | 5.98 | |
| Peptide content (%w/w) | 98.3 | 86.47 | |
| 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
- 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
- 02 May 2026
- Submitted to the index
- 10 May 2026
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 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 MKM-2512-B2992 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042898 | MKM-2512-B2992 | PeptideMeter | 2026-Q2 | 98.48 | 6.39 | 104.4 | Supplier-supplied | 1 | FAIL |
| AX-2026-042899 | MKM-2512-B2992 | Janoshik | 2026-Q2 | 98.52 | 6.55 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042900 | MKM-2512-B2992 | PeptideMeter | 2026-Q2 | 98.39 | 7.12 | 102.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-042901 | MKM-2512-B2992 | Janoshik | 2026-Q2 | 99.03 | 7.24 | 99.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042902 | MKM-2512-B2992 | PeptideMeter | 2026-Q2 | 99.35 | 7.26 | 107.2 | Supplier-supplied | 2 | FAIL |
| AX-2026-042903 | MKM-2512-B2992 | Janoshik | 2026-Q2 | 98.61 | 6.89 | 99.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042904 | MKM-2512-B2992 | Janoshik | 2026-Q2 | 98.53 | 7.16 | 91.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042905 | MKM-2512-B2992 | Janoshik | 2026-Q2 | 99.04 | 6.55 | 98.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042906 | MKM-2512-B2992 | Janoshik | 2026-Q2 | 98.43 | 6.67 | — | Buyer-sourced | 1 | FAIL |
Cross-sections
- All Semax records n=160
- All MKM records n=272
- All Kestrel records n=404
- All 2026-Q2 records n=1009
- Semax by supplier
- Semax impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042368 | HJ | HJ-2603-V4363 | Nordanalyt | 2026-Q3 | 99.17 | 7.26 | 106.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042367 | HJ | HJ-2603-V4363 | Kestrel | 2026-Q3 | 99.10 | 6.78 | 93.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042260 | Homopeptide | HOMO-2605-S1342 | Medutest | 2026-Q3 | 99.44 | 6.06 | 92.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-042370 | HJ | HJ-2603-V4363 | Janoshik | 2026-Q3 | 98.94 | 7.16 | 104.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042369 | HJ | HJ-2603-V4363 | Janoshik | 2026-Q3 | 99.26 | 7.67 | 95.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041947 | TFC | TFC-2602-F4591 | Nordanalyt | 2026-Q2 | 99.29 | 8.98 | 92.3 | Supplier-supplied | 0 | PASS |
| AX-2026-041940 | TFC | TFC-2602-F4591 | Janoshik | 2026-Q2 | 99.06 | 8.38 | 98.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043141 | SSA | SSA-2604-L7628 | Kestrel | 2026-Q2 | 98.84 | 8.58 | 93.2 | Supplier-supplied | 2 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042943 | Adipotide | MKM-2606-K4013 | Janoshik | 2026-Q3 | 97.92 | 6.31 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042891 | CJC-1295 (no DAC) | MKM-2603-V2347 | Janoshik | 2026-Q3 | 99.28 | 3.63 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042942 | Adipotide | MKM-2606-K4013 | VendorInvestigate | 2026-Q3 | 97.04 | 5.56 | 94.6 | Buyer-sourced | 1 | FAIL |
| AX-2026-042914 | Gonadorelin | MKM-2604-A2596 | Janoshik | 2026-Q2 | 99.93 | 5.19 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042884 | BPC-157 | MKM-2605-X2575 | Nordanalyt | 2026-Q2 | 98.12 | 2.89 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-042946 | Tirzepatide | MKM-2601-L3752 | Medutest | 2026-Q2 | 97.71 | 8.10 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-042911 | Gonadorelin | MKM-2604-A2596 | Medutest | 2026-Q2 | 99.08 | 5.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042932 | L-Glutathione (reduced) | MKM-2511-F2902 | Janoshik | 2026-Q2 | 98.57 | 8.41 | 92.9 | Supplier-supplied | 1 | MARGINAL |