AX-2024-005407
Semax · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2402-W3946
- Report ID
- AX-2024-005407
- Compound
- Semax
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2402-W3946
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 15 Jun 2024
- Submitted
- 09 Jul 2024
- Quarter
- 2024-Q2
- Submitter
- am.hartmann
- 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 | 98.64 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.36 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — diketopiperazine (−18 Da) | 0.90 | % 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) | 813.3548 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.75 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.56 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.50 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.761 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.80 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.14 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.31 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.04 | EU/mg | ≤ 5.0 | PASS |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White cake, partial shrinkage from vial wall | — | 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 | 4.93 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 5.86 | min | 5.98 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.07 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 83,265 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.60 | — | 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 | 5.86 | 4,794,210 | 98.64 | — |
| 2 | diketopiperazine (−18 Da) | 5.99 | 43,743 | 0.90 | -18.011 |
| 3 | N-acetyl semax (+42 Da) | 6.21 | 10,693 | 0.22 | +42.011 |
| 4 | Met1 sulfoxide (+16 Da) | 5.56 | 5,832 | 0.12 | +15.995 |
| 5 | des-Met (−131 Da) | 6.03 | 5,832 | 0.12 | -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 | 407.6847 | 0.0004 | 57.2 |
| 1+ | 814.3614 | 814.3621 | 0.0007 | 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 | 6.80 |
| Counter-ion (acetate) | ion chromatography | 5.14 |
| Residual solvent + inorganic residue | estimated | 0.31 |
| Total peptide content | by difference | 87.75 |
| 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 | 98.64 | divergence +0.23 pp vs batch median |
| Total impurities (% area) | not stated | 1.36 | |
| Largest single impurity (% area) | not stated | 0.90 | |
| Water (%) | 4.5 | 6.80 | |
| Counter-ion (%) | not stated | 5.14 | |
| Peptide content (%w/w) | 90.7 | 87.75 | |
| Endotoxin (EU/mg) | not stated | 1.04 | |
| 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, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 15 Jun 2024
- Submitted to the index
- 09 Jul 2024
- 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 WXT-2402-W3946 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005401 | WXT-2402-W3946 | Kestrel | 2024-Q2 | 98.09 | 6.85 | — | Supplier-supplied | 0 | FAIL |
| AX-2024-005402 | WXT-2402-W3946 | Kestrel | 2024-Q2 | 98.50 | 6.45 | 89.4 | Laboratory-retained | 1 | MARGINAL |
| AX-2024-005403 | WXT-2402-W3946 | Kestrel | 2024-Q2 | 98.79 | 6.61 | 93.4 | Supplier-supplied | 0 | PASS |
| AX-2024-005404 | WXT-2402-W3946 | Medutest | 2024-Q2 | 98.20 | 6.77 | 92.6 | Supplier-supplied | 0 | FAIL |
| AX-2024-005405 | WXT-2402-W3946 | Medutest | 2024-Q2 | 98.50 | 6.59 | 103.2 | Laboratory-retained | 1 | MARGINAL |
| AX-2024-005406 | WXT-2402-W3946 | Medutest | 2024-Q2 | 98.61 | 7.19 | — | Supplier-supplied | 1 | FAIL |
| AX-2024-005408 | WXT-2402-W3946 | Janoshik | 2024-Q2 | 98.99 | 6.60 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005409 | WXT-2402-W3946 | Nordanalyt | 2024-Q2 | 98.34 | 6.76 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005410 | WXT-2402-W3946 | Medutest | 2024-Q2 | 99.17 | 6.77 | — | Supplier-supplied | 0 | PASS |
| AX-2024-005411 | WXT-2402-W3946 | Medutest | 2024-Q2 | 98.28 | 6.72 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005412 | WXT-2402-W3946 | Nordanalyt | 2024-Q2 | 98.84 | 6.52 | 105.8 | Supplier-supplied | 0 | PASS |
| AX-2024-005413 | WXT-2402-W3946 | Medutest | 2024-Q2 | 98.20 | 6.68 | — | Supplier-supplied | 0 | FAIL |
Cross-sections
- All Semax records n=160
- All WXT records n=353
- All Medutest records n=940
- All 2024-Q2 records n=349
- 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-2026-043488 | Pramlintide | WXT-2603-D6052 | Janoshik | 2026-Q3 | 97.87 | 4.37 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043406 | Semaglutide | WXT-2604-C4728 | Janoshik | 2026-Q3 | 97.24 | 4.65 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043421 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.15 | 3.09 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043420 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.62 | 3.07 | 96.4 | Supplier-supplied | 0 | PASS |
| AX-2026-043423 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.28 | 3.86 | 98.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043401 | Semaglutide | WXT-2604-C4728 | Medutest | 2026-Q3 | 97.70 | 4.78 | 91.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043400 | Semaglutide | WXT-2604-C4728 | Nordanalyt | 2026-Q3 | 96.86 | 4.11 | 106.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-043422 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.35 | 3.59 | — | Supplier-supplied | 1 | MARGINAL |