AX-2026-041641
Selank · 20 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2601-N8430
- Report ID
- AX-2026-041641
- Compound
- Selank
- Compound class
- Neuroactive and cognitive peptides
- Supplier
- QSC — Qingdao Sigma Chemical Co., Ltd.
- Batch / lot
- QSC-2601-N8430
- Declared label claim
- 20mg
- Laboratory
- Janoshik Analytical
- Assay date
- 24 Jan 2026
- Submitted
- 06 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- r.kirchner
- 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, 30 min gradient, 214 nm | 99.93 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.07 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — tuftsin fragment (−417 Da) | 0.05 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 87.10 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.04 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 22.87 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 19.906 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.31 | % | ≤ 12.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.65 | % | ≤ 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 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 | 4.96 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 6.29 | min | 6.42 ± 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 | 49,177 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs diketopiperazine (−18 Da) | 1.55 | — | 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 | 6.29 | 4,856,908 | 99.93 | — |
| 2 | tuftsin fragment (−417 Da) | 5.67 | 2,430 | 0.05 | -417.235 |
| 3 | diketopiperazine (−18 Da) | 6.47 | 972 | 0.02 | -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.
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 | 6.31 |
| Counter-ion (acetate) | ion chromatography | 5.65 |
| Residual solvent + inorganic residue | estimated | 0.94 |
| Total peptide content | by difference | 87.10 |
| 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) | 99.90 | 99.93 | divergence -0.03 pp vs batch median |
| Total impurities (% area) | not stated | 0.07 | |
| Largest single impurity (% area) | not stated | 0.05 | |
| Water (%) | not stated | 6.31 | |
| Counter-ion (%) | 6.6 | 5.65 | |
| Peptide content (%w/w) | 89.3 | 87.10 | |
| 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, 2 d) → assay. Submitter did not handle the vial.
- Assay date
- 24 Jan 2026
- Submitted to the index
- 06 Feb 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot QSC-2601-N8430 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041639 | QSC-2601-N8430 | Janoshik | 2026-Q1 | 99.81 | 6.37 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041640 | QSC-2601-N8430 | Janoshik | 2026-Q1 | 99.93 | 6.96 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041642 | QSC-2601-N8430 | PeptideMeter | 2026-Q1 | 99.77 | 7.17 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041643 | QSC-2601-N8430 | PeptideMeter | 2026-Q1 | 99.90 | 6.68 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041644 | QSC-2601-N8430 | Janoshik | 2026-Q1 | 99.39 | 6.80 | 106.8 | Supplier-supplied | 0 | PASS |
| AX-2026-041645 | QSC-2601-N8430 | Janoshik | 2026-Q1 | 99.93 | 6.62 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041646 | QSC-2601-N8430 | Janoshik | 2026-Q1 | 99.93 | 5.61 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041647 | QSC-2601-N8430 | Janoshik | 2026-Q1 | 99.93 | 6.22 | — | Supplier-supplied | 0 | PASS |
Cross-sections
- All Selank records n=112
- All QSC records n=495
- All Janoshik records n=3159
- All 2026-Q1 records n=832
- 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-2026-041683 | CJC-1295 (no DAC) | QSC-2606-V8637 | Janoshik | 2026-Q3 | 99.93 | 3.63 | 97.1 | Supplier-supplied | 1 | FAIL |
| AX-2026-041727 | CJC-1295 with DAC | QSC-2602-E9474 | Janoshik | 2026-Q3 | 98.88 | 6.62 | 105.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041728 | CJC-1295 with DAC | QSC-2602-E9474 | VendorInvestigate | 2026-Q3 | 98.42 | 7.04 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041734 | CJC-1295 with DAC | QSC-2602-E9474 | Medutest | 2026-Q3 | 99.43 | 7.17 | 105.5 | Supplier-supplied | 2 | FAIL |
| AX-2026-041652 | Liraglutide | QSC-2605-W8602 | Nordanalyt | 2026-Q3 | 99.33 | 6.55 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041730 | CJC-1295 with DAC | QSC-2602-E9474 | PeptideMeter | 2026-Q3 | 98.79 | 6.93 | 95.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041686 | CJC-1295 (no DAC) | QSC-2606-V8637 | Janoshik | 2026-Q3 | 99.93 | 4.04 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041653 | Liraglutide | QSC-2605-W8602 | VendorInvestigate | 2026-Q3 | 98.82 | 5.95 | — | Buyer-sourced | 0 | PASS |