AX-2025-018814
Kisspeptin-10 · 10 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2412-W8004
- Report ID
- AX-2025-018814
- Compound
- Kisspeptin-10
- Compound class
- Melanocortin-receptor peptides
- Supplier
- QSC — Qingdao Sigma Chemical Co., Ltd.
- Batch / lot
- QSC-2412-W8004
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 12 Jan 2025
- Submitted
- 03 Feb 2025
- Quarter
- 2025-Q1
- Submitter
- so.moreau
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the melanocortin-receptor 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 | 99.57 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.43 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-Tyr (−163 Da) | 0.20 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1301.6300 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1301.6336 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +2.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.92 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 90.53 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.81 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.786 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.47 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 2.94 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.67 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.41 | 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 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 | 5.50 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.22 | min | 9.14 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.05 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 42,909 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 0.66 | — | 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 | Kisspeptin-10 — main peak | 9.22 | 4,839,411 | 99.57 | — |
| 2 | des-Tyr (−163 Da) | 8.66 | 9,721 | 0.20 | -163.063 |
| 3 | oxidised Trp (+16 Da) | 8.88 | 6,804 | 0.14 | +15.995 |
| 4 | C-terminal free acid (+1 Da) | 9.40 | 2,430 | 0.05 | +0.984 |
| 5 | [D-Trp]-epimer | 9.10 | 1,944 | 0.04 | 0.000 |
| 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 1301.6300 Da, computed from C63H83N17O14. 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 (%) |
|---|---|---|---|---|
| 3+ | 434.8839 | 434.8851 | 0.0012 | 8.2 |
| 2+ | 651.8223 | 651.8241 | 0.0018 | 57.3 |
| 1+ | 1302.6373 | 1302.6409 | 0.0036 | 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 | 5.47 |
| Counter-ion (acetate) | ion chromatography | 2.94 |
| Residual solvent + inorganic residue | estimated | 0.67 |
| Total peptide content | by difference | 90.92 |
| 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 | 99.57 | divergence +0.33 pp vs batch median |
| Total impurities (% area) | not stated | 0.43 | |
| Largest single impurity (% area) | not stated | 0.20 | |
| Water (%) | not stated | 5.47 | |
| Counter-ion (%) | not stated | 2.94 | |
| Peptide content (%w/w) | 91.7 | 90.92 | |
| Endotoxin (EU/mg) | 0.32 | 0.41 | |
| 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
- 12 Jan 2025
- Submitted to the index
- 03 Feb 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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-2412-W8004 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018810 | QSC-2412-W8004 | Janoshik | 2025-Q1 | 99.76 | 5.21 | 90.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018811 | QSC-2412-W8004 | VendorInvestigate | 2025-Q1 | 99.09 | 5.35 | 101.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-018812 | QSC-2412-W8004 | PeptideMeter | 2025-Q1 | 99.85 | 5.96 | — | Supplier-supplied | 0 | PASS |
| AX-2025-018813 | QSC-2412-W8004 | PeptideMeter | 2025-Q1 | 99.29 | 5.21 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018815 | QSC-2412-W8004 | PeptideMeter | 2025-Q1 | 99.81 | 5.70 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018816 | QSC-2412-W8004 | Nordanalyt | 2025-Q1 | 99.53 | 5.48 | 92.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018817 | QSC-2412-W8004 | Nordanalyt | 2025-Q1 | 99.93 | 5.89 | 98.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018818 | QSC-2412-W8004 | Nordanalyt | 2025-Q1 | 99.57 | 6.16 | 98.8 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042461 | SWB | SWB-2603-D6238 | Janoshik | 2026-Q3 | 98.35 | 4.65 | 96.5 | Supplier-supplied | 3 | FAIL |
| AX-2026-043176 | GL Biochem | GLBI-2608-N8085 | Medutest | 2026-Q3 | 98.22 | 3.30 | 92.5 | Buyer-sourced | 2 | FAIL |
| AX-2026-043180 | GL Biochem | GLBI-2608-N8085 | Janoshik | 2026-Q3 | 98.69 | 3.37 | 103.8 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042460 | SWB | SWB-2603-D6238 | Kestrel | 2026-Q3 | 99.55 | 4.21 | 90.8 | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042458 | SWB | SWB-2603-D6238 | Kestrel | 2026-Q3 | 98.51 | 4.71 | 102.4 | Supplier-supplied | 3 | MARGINAL |
| AX-2026-043178 | GL Biochem | GLBI-2608-N8085 | Janoshik | 2026-Q3 | 98.24 | 4.44 | 96.0 | Supplier-supplied | 2 | FAIL |
| AX-2026-042463 | SWB | SWB-2603-D6238 | Nordanalyt | 2026-Q3 | 98.35 | 4.93 | 98.6 | Supplier-supplied | 3 | FAIL |
| AX-2026-042465 | SWB | SWB-2603-D6238 | Kestrel | 2026-Q3 | 99.03 | 4.83 | 96.4 | Supplier-supplied | 3 | MARGINAL |
| 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 |