AX-2024-005432
Selank · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2406-W5390
- Report ID
- AX-2024-005432
- Compound
- Selank
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2406-W5390
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 28 Aug 2024
- Submitted
- 12 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- a.chowdhury
- 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 | 99.35 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.65 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — diketopiperazine (−18 Da) | 0.27 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 751.4402 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 751.4505 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +13.7 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 84.20 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.65 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.48 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.603 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 96.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 9.64 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.62 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.54 | % | — | 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 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 | 4.24 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 5.44 | min | 5.44 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.03 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 49,739 | — | ≥ 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 | Selank — main peak | 5.44 | 4,828,718 | 99.35 | — |
| 2 | diketopiperazine (−18 Da) | 5.59 | 13,123 | 0.27 | -18.011 |
| 3 | des-Thr (−101 Da) | 5.22 | 8,749 | 0.18 | -101.048 |
| 4 | tuftsin fragment (−417 Da) | 4.92 | 6,318 | 0.13 | -417.235 |
| 5 | acetyl adduct (+42 Da) | 5.72 | 3,402 | 0.07 | +42.011 |
| 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 751.4402 Da, computed from C33H57N11O9. 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+ | 376.7274 | 376.7325 | 0.0051 | 54.1 |
| 1+ | 752.4475 | 752.4578 | 0.0103 | 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 | 9.64 |
| Counter-ion (acetate) | ion chromatography | 5.62 |
| Residual solvent + inorganic residue | estimated | 0.54 |
| Total peptide content | by difference | 84.20 |
| 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) | 99.64 | 99.35 | divergence +0.63 pp vs batch median |
| Total impurities (% area) | 0.36 | 0.65 | |
| Largest single impurity (% area) | 0.22 | 0.27 | |
| Water (%) | 8.6 | 9.64 | |
| Counter-ion (%) | not stated | 5.62 | |
| Peptide content (%w/w) | not stated | 84.20 | |
| Endotoxin (EU/mg) | 0.24 | 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, 4 d) → assay. Submitter did not handle the vial.
- Assay date
- 28 Aug 2024
- Submitted to the index
- 12 Sep 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-2406-W5390 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005428 | WXT-2406-W5390 | Janoshik | 2024-Q3 | 98.87 | 9.68 | — | Supplier-supplied | 0 | FAIL |
| AX-2024-005429 | WXT-2406-W5390 | Janoshik | 2024-Q3 | 98.97 | 9.91 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005430 | WXT-2406-W5390 | Janoshik | 2024-Q3 | 98.54 | 9.53 | 101.1 | Supplier-supplied | 0 | FAIL |
| AX-2024-005431 | WXT-2406-W5390 | Janoshik | 2024-Q3 | 99.61 | 9.90 | 92.2 | Supplier-supplied | 0 | PASS |
| AX-2024-005433 | WXT-2406-W5390 | Janoshik | 2024-Q3 | 99.65 | 8.74 | 99.1 | Supplier-supplied | 0 | PASS |
| AX-2024-005434 | WXT-2406-W5390 | Medutest | 2024-Q3 | 99.05 | 9.66 | 94.8 | Buyer-sourced | 0 | PASS |
| AX-2024-005435 | WXT-2406-W5390 | Janoshik | 2024-Q3 | 99.07 | 9.06 | 104.1 | Supplier-supplied | 0 | PASS |
| AX-2024-005436 | WXT-2406-W5390 | VendorInvestigate | 2024-Q3 | 98.60 | 9.32 | 98.6 | Buyer-sourced | 0 | FAIL |
| AX-2024-005437 | WXT-2406-W5390 | VendorInvestigate | 2024-Q3 | 98.60 | 9.34 | — | Buyer-sourced | 0 | FAIL |
Cross-sections
- All Selank records n=112
- All WXT records n=353
- All Medutest records n=940
- All 2024-Q3 records n=522
- Selank by supplier
- Selank impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042737 | GGPeps | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | GGPeps | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | GGPeps | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | GGPeps | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | GGPeps | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042797 | GGPeps | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042743 | GGPeps | GGPE-2603-J9708 | Medutest | 2026-Q3 | 99.59 | 9.37 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042799 | GGPeps | GGPE-2602-G2056 | Nordanalyt | 2026-Q3 | 98.77 | 8.33 | — | Supplier-supplied | 0 | FAIL |
| 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 |