AX-2026-042755
Melanotan II · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2603-P1474
- Report ID
- AX-2026-042755
- Compound
- Melanotan II
- Compound class
- Melanocortin-receptor peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2603-P1474
- Declared label claim
- 10mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 20 Aug 2026
- Submitted
- 22 Aug 2026
- Quarter
- 2026-Q3
- Submitter
- b.abubakar
- 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, 35 min gradient, 214 nm | 99.25 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.75 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — linear (open-lactam) precursor (+18 Da) | 0.45 | % 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) | 1023.5418 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +1.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.28 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.61 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.20 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.038 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.58 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.90 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.24 | % | — | 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, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| 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 | 5.37 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 11.33 | min | 11.35 ± 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 | 57,608 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [L-Phe7]-diastereomer | 0.96 | — | 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 | 11.33 | 4,823,858 | 99.25 | — |
| 2 | linear (open-lactam) precursor (+18 Da) | 10.47 | 21,871 | 0.45 | +18.011 |
| 3 | des-acetyl MT-II (−42 Da) | 10.77 | 8,263 | 0.17 | -42.011 |
| 4 | [L-Phe7]-diastereomer | 11.14 | 3,888 | 0.08 | 0.000 |
| 5 | oxidised Trp (+16 Da) | 10.91 | 1,458 | 0.03 | +15.995 |
| 6 | MT-II dimer (head-to-tail) | 14.07 | 972 | 0.02 | +1023.540 |
| 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 | 342.1879 | 0.0006 | 7.7 |
| 2+ | 512.7774 | 512.7782 | 0.0008 | 55.6 |
| 1+ | 1024.5475 | 1024.5491 | 0.0016 | 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 | 6.58 |
| Counter-ion (acetate) | ion chromatography | 3.90 |
| Residual solvent + inorganic residue | estimated | 0.24 |
| Total peptide content | by difference | 89.28 |
| 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) | 99.10 | 99.25 | divergence -0.14 pp vs batch median |
| Total impurities (% area) | 0.90 | 0.75 | |
| Largest single impurity (% area) | 0.42 | 0.45 | |
| Water (%) | 6.6 | 6.58 | |
| Counter-ion (%) | not stated | 3.90 | |
| Peptide content (%w/w) | not stated | 89.28 | |
| 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (ambient, 15 d) → laboratory (hand-carried, 3 d) → assay.
- Assay date
- 20 Aug 2026
- Submitted to the index
- 22 Aug 2026
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 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-2603-P1474 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042756 | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042757 | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042758 | GGPE-2603-P1474 | PeptideMeter | 2026-Q3 | 99.23 | 6.96 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042759 | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.15 | 6.71 | 105.1 | Buyer-sourced | 0 | PASS |
| AX-2026-042760 | GGPE-2603-P1474 | Medutest | 2026-Q3 | 99.43 | 7.02 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042757 | GGPeps | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042756 | GGPeps | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042760 | GGPeps | GGPE-2603-P1474 | Medutest | 2026-Q3 | 99.43 | 7.02 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042758 | GGPeps | GGPE-2603-P1474 | PeptideMeter | 2026-Q3 | 99.23 | 6.96 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042759 | GGPeps | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.15 | 6.71 | 105.1 | Buyer-sourced | 0 | PASS |
| AX-2026-042168 | JEEP | JEEP-2604-R9103 | Nordanalyt | 2026-Q2 | 99.40 | 5.71 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042164 | JEEP | JEEP-2604-R9103 | Janoshik | 2026-Q2 | 99.54 | 5.23 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042171 | JEEP | JEEP-2604-R9103 | Kestrel | 2026-Q2 | 99.59 | 5.11 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042784 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Medutest | 2026-Q3 | 98.27 | 4.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042786 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 3.77 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042858 | Selank | GGPE-2603-J2447 | VendorInvestigate | 2026-Q3 | 98.87 | 8.85 | 99.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042783 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 4.45 | 90.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042757 | Melanotan II | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042785 | CJC-1295 (no DAC) | GGPE-2606-E1234 | PeptideMeter | 2026-Q3 | 97.70 | 4.64 | 91.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042756 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042782 | CJC-1295 (no DAC) | GGPE-2606-E1234 | PeptideMeter | 2026-Q3 | 98.06 | 4.59 | — | Buyer-sourced | 0 | PASS |