AX-2024-004407
Kisspeptin-10 · 10 mg declared · Asymchem Laboratories (Tianjin) Co., Ltd. · lot ASY-{CAT}-2919
- Report ID
- AX-2024-004407
- Compound
- Kisspeptin-10
- Compound class
- Melanocortin-receptor peptides
- Supplier
- ASY — Asymchem Laboratories (Tianjin) Co., Ltd.
- Batch / lot
- ASY-{CAT}-2919
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 16 Dec 2024
- Submitted
- 26 Dec 2024
- Quarter
- 2024-Q4
- Submitter
- v.novak
- Sample provenance
- Buyer-sourced
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 | 99.18 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.82 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 0.45 | % 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 | 90.76 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 90.02 | %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 | 9.731 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.17 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.47 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.60 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.84 | 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 | 5.12 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.10 | min | 9.14 ± 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 | 57,718 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 0.77 | — | 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 | 9.10 | 4,820,455 | 99.18 | — |
| 2 | oxidised Trp (+16 Da) | 8.76 | 21,871 | 0.45 | +15.995 |
| 3 | C-terminal free acid (+1 Da) | 9.28 | 7,776 | 0.16 | +0.984 |
| 4 | des-Tyr (−163 Da) | 8.54 | 5,346 | 0.11 | -163.063 |
| 5 | [D-Trp]-epimer | 8.98 | 4,860 | 0.10 | 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.
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 | 5.17 |
| Counter-ion (acetate) | ion chromatography | 3.47 |
| Residual solvent + inorganic residue | estimated | 0.60 |
| Total peptide content | by difference | 90.76 |
| 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) | 99.88 | 99.18 | divergence +0.22 pp vs batch median |
| Total impurities (% area) | 0.12 | 0.82 | |
| Largest single impurity (% area) | not stated | 0.45 | |
| Water (%) | 4.7 | 5.17 | |
| Counter-ion (%) | not stated | 3.47 | |
| Peptide content (%w/w) | 90.5 | 90.76 | |
| Endotoxin (EU/mg) | not stated | 0.84 | |
| 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 → third-party forwarder (14 d) → laboratory (courier, cold pack, 10 d) → assay.
- Assay date
- 16 Dec 2024
- Submitted to the index
- 26 Dec 2024
- 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 ASY-{CAT}-2919 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004406 | ASY-{CAT}-2919 | Janoshik | 2024-Q4 | 99.32 | 5.40 | 92.4 | Buyer-sourced | 0 | PASS |
| AX-2024-004408 | ASY-{CAT}-2919 | Nordanalyt | 2024-Q4 | 99.46 | 5.49 | 91.3 | Buyer-sourced | 0 | PASS |
| AX-2024-004409 | ASY-{CAT}-2919 | Medutest | 2024-Q4 | 99.10 | 5.07 | 100.9 | Buyer-sourced | 0 | PASS |
| AX-2024-004410 | ASY-{CAT}-2919 | Janoshik | 2024-Q4 | 99.66 | 5.47 | 92.3 | Buyer-sourced | 0 | PASS |
| AX-2025-019056 | ASY-{CAT}-2919 | Medutest | 2024-Q4 | 99.93 | 5.85 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004411 | ASY-{CAT}-2919 | Nordanalyt | 2024-Q4 | 99.56 | 5.72 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004412 | ASY-{CAT}-2919 | Medutest | 2024-Q4 | 99.93 | 4.88 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004413 | ASY-{CAT}-2919 | VendorInvestigate | 2024-Q4 | 99.78 | 5.55 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004414 | ASY-{CAT}-2919 | Kestrel | 2024-Q4 | 99.93 | 4.83 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004415 | ASY-{CAT}-2919 | Medutest | 2024-Q4 | 99.93 | 5.56 | 106.8 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043179 | GL Biochem | GLBI-2608-N7715 | Medutest | 2026-Q3 | 98.97 | 4.37 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043178 | GL Biochem | GLBI-2608-N7715 | Janoshik | 2026-Q3 | 98.50 | 4.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043184 | GL Biochem | GLBI-2608-N7715 | Janoshik | 2026-Q3 | 98.99 | 3.63 | 100.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043185 | GL Biochem | GLBI-2608-N7715 | Medutest | 2026-Q3 | 98.71 | 3.71 | 107.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043182 | GL Biochem | GLBI-2608-N7715 | Janoshik | 2026-Q3 | 98.93 | 3.86 | 95.7 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043183 | GL Biochem | GLBI-2608-N7715 | PeptideMeter | 2026-Q3 | 98.54 | 4.17 | 102.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043186 | GL Biochem | GLBI-2608-N7715 | Janoshik | 2026-Q3 | 98.56 | 3.60 | 96.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043181 | GL Biochem | GLBI-2608-N7715 | Janoshik | 2026-Q3 | 98.77 | 4.06 | 95.2 | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041776 | TB-500 | ASY-{CAT}-2167 | Janoshik | 2026-Q3 | 99.92 | 4.61 | 98.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041777 | TB-500 | ASY-{CAT}-2167 | PeptideMeter | 2026-Q3 | 99.78 | 4.09 | 92.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041786 | Retatrutide | ASY-{CAT}-2288 | VendorInvestigate | 2026-Q3 | 98.78 | 6.59 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041782 | TB-500 | ASY-{CAT}-2167 | Nordanalyt | 2026-Q3 | 99.93 | 3.94 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041793 | Retatrutide | ASY-{CAT}-2288 | Nordanalyt | 2026-Q3 | 98.34 | 6.16 | 104.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041784 | Retatrutide | ASY-{CAT}-2288 | PeptideMeter | 2026-Q3 | 98.15 | 6.26 | 91.9 | Buyer-sourced | 0 | PASS |
| AX-2026-041774 | TB-500 | ASY-{CAT}-2167 | PeptideMeter | 2026-Q3 | 99.93 | 4.41 | 96.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041780 | TB-500 | ASY-{CAT}-2167 | Janoshik | 2026-Q3 | 99.93 | 3.48 | 102.5 | Buyer-sourced | 1 | FAIL |