AX-2026-042707
Melanotan II · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2509-H8939
- Report ID
- AX-2026-042707
- Compound
- Melanotan II
- Compound class
- Melanocortin-receptor peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2509-H8939
- Declared label claim
- 10mg
- Laboratory
- VendorInvestigate
- Assay date
- 18 Feb 2026
- Submitted
- 26 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- c.batista
- 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, 32 min gradient, 214 nm | 98.36 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 1.64 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — [L-Phe7]-diastereomer | 0.61 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1023.5402 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1023.5446 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +4.3 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.40 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.95 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.57 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.191 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.40 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.89 | % | ≤ 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 cake, partially collapsed | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Slow dissolution, >5 min to clarity | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.40 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 10.50 | min | 10.44 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.96 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 73,666 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [L-Phe7]-diastereomer | 1.08 | — | 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 | Melanotan II — main peak | 10.50 | 4,780,601 | 98.36 | — |
| 2 | [L-Phe7]-diastereomer | 10.33 | 29,648 | 0.61 | 0.000 |
| 3 | linear (open-lactam) precursor (+18 Da) | 9.71 | 22,843 | 0.47 | +18.011 |
| 4 | MT-II dimer (head-to-tail) | 13.01 | 18,955 | 0.39 | +1023.540 |
| 5 | des-acetyl MT-II (−42 Da) | 9.99 | 5,346 | 0.11 | -42.011 |
| 6 | oxidised Trp (+16 Da) | 10.12 | 2,916 | 0.06 | +15.995 |
| 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 1023.5402 Da, computed from C50H69N15O9. 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+ | 342.1873 | 342.1888 | 0.0015 | 7.7 |
| 2+ | 512.7774 | 512.7796 | 0.0022 | 55.0 |
| 1+ | 1024.5475 | 1024.5519 | 0.0044 | 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 | 5.40 |
| Counter-ion (acetate) | ion chromatography | 5.89 |
| Residual solvent + inorganic residue | estimated | 0.31 |
| Total peptide content | by difference | 88.40 |
| 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) | 99.17 | 98.36 | divergence +0.63 pp vs batch median |
| Total impurities (% area) | 0.83 | 1.64 | |
| Largest single impurity (% area) | not stated | 0.61 | |
| Water (%) | 3.8 | 5.40 | |
| Counter-ion (%) | not stated | 5.89 | |
| Peptide content (%w/w) | 91.4 | 88.40 | |
| 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 (2–8 °C, 32 d) → laboratory (courier, ambient, 3 d) → assay.
- Assay date
- 18 Feb 2026
- Submitted to the index
- 26 Feb 2026
- Laboratory
- VendorInvestigate, Riga, Latvia
- Method basis
- 32 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 GGPE-2509-H8939 n=8
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042704 | GGPE-2509-H8939 | Janoshik | 2026-Q1 | 98.60 | 5.51 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042705 | GGPE-2509-H8939 | VendorInvestigate | 2026-Q1 | 98.33 | 5.92 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042706 | GGPE-2509-H8939 | Medutest | 2026-Q1 | 99.52 | 5.18 | 97.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042708 | GGPE-2509-H8939 | Medutest | 2026-Q1 | 98.70 | 4.73 | 105.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042709 | GGPE-2509-H8939 | PeptideMeter | 2026-Q1 | 99.41 | 6.06 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042710 | GGPE-2509-H8939 | Nordanalyt | 2026-Q1 | 98.47 | 5.20 | 96.4 | Buyer-sourced | 1 | FAIL |
| AX-2026-042711 | GGPE-2509-H8939 | PeptideMeter | 2026-Q1 | 98.39 | 5.47 | 93.9 | Laboratory-retained | 1 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042648 | GGPeps | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042479 | SWB | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.16 | 3.67 | 94.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042481 | SWB | SWB-2603-A5707 | Medutest | 2026-Q3 | 98.95 | 3.37 | 90.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042650 | GGPeps | GGPE-2603-P8735 | Medutest | 2026-Q3 | 99.86 | 6.49 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042483 | SWB | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.38 | 3.73 | 107.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042651 | GGPeps | GGPE-2603-P8735 | PeptideMeter | 2026-Q3 | 99.53 | 7.04 | 90.7 | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042478 | SWB | SWB-2603-A5707 | VendorInvestigate | 2026-Q3 | 98.73 | 4.34 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042482 | SWB | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.22 | 4.66 | — | Supplier-supplied | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |