AX-2024-005036
Selank · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2405-H5953
- Report ID
- AX-2024-005036
- Compound
- Selank
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2405-H5953
- Declared label claim
- 10mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 09 Jul 2024
- Submitted
- 02 Aug 2024
- Quarter
- 2024-Q3
- Submitter
- an.silva
- 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, 15 min gradient, 214 nm | 98.00 | % area | ≥ 99.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.00 | % area | ≤ 1.0 | FAIL |
| Largest single impurity | RP-HPLC — des-Thr (−101 Da) | 1.00 | % 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) | 751.4483 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +10.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 84.71 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.02 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 12.60 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.461 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.29 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 7.69 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.31 | % | — | 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 | 5.86 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 3.34 | min | 3.47 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.15 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 52,577 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.51 | — | 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 | 3.34 | 4,763,104 | 98.00 | — |
| 2 | des-Thr (−101 Da) | 3.21 | 48,603 | 1.00 | -101.048 |
| 3 | acetyl adduct (+42 Da) | 3.51 | 22,357 | 0.46 | +42.011 |
| 4 | tuftsin fragment (−417 Da) | 3.03 | 16,525 | 0.34 | -417.235 |
| 5 | diketopiperazine (−18 Da) | 3.43 | 9,721 | 0.20 | -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 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 | 376.7314 | 0.0040 | 53.3 |
| 1+ | 752.4475 | 752.4556 | 0.0081 | 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 | 7.29 |
| Counter-ion (acetate) | ion chromatography | 7.69 |
| Residual solvent + inorganic residue | estimated | 0.31 |
| Total peptide content | by difference | 84.71 |
| 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) | 97.93 | 98.00 | divergence +0.12 pp vs batch median |
| Total impurities (% area) | 2.07 | 2.00 | |
| Largest single impurity (% area) | 1.51 | 1.00 | |
| Water (%) | not stated | 7.29 | |
| Counter-ion (%) | 5.5 | 7.69 | |
| Peptide content (%w/w) | 97.7 | 84.71 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (−20 °C, 30 d) → laboratory (courier, dry ice, 2 d) → assay.
- Assay date
- 09 Jul 2024
- Submitted to the index
- 02 Aug 2024
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
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-2405-H5953 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005035 | KP-2405-H5953 | Janoshik | 2024-Q3 | 97.62 | 7.83 | — | Buyer-sourced | 0 | FAIL |
Cross-sections
- All Selank records n=102
- All KP records n=223
- All Kestrel records n=407
- All 2024-Q3 records n=464
- Selank by supplier
- Selank impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042858 | GGPeps | GGPE-2603-J2447 | VendorInvestigate | 2026-Q3 | 98.87 | 8.85 | 99.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042859 | GGPeps | GGPE-2603-J2447 | PeptideMeter | 2026-Q3 | 98.92 | 9.48 | 103.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-041759 | TFS | TFS-{CAT}-1712 | Janoshik | 2026-Q2 | 99.93 | 8.13 | 102.2 | Buyer-sourced | 0 | PASS |
| AX-2026-042912 | GGPeps | GGPE-2601-J3130 | Janoshik | 2026-Q2 | 99.75 | 9.44 | 89.7 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041760 | TFS | TFS-{CAT}-1712 | Janoshik | 2026-Q2 | 99.82 | 7.70 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041752 | TFS | TFS-{CAT}-1712 | Medutest | 2026-Q2 | 99.63 | 7.43 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042915 | GGPeps | GGPE-2601-J3130 | PeptideMeter | 2026-Q2 | 99.53 | 10.03 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042910 | GGPeps | GGPE-2601-J3130 | VendorInvestigate | 2026-Q2 | 99.62 | 9.21 | 105.0 | 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 |