AX-2026-042651
Melanotan II · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2603-P8735
- Report ID
- AX-2026-042651
- Compound
- Melanotan II
- Compound class
- Melanocortin-receptor peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2603-P8735
- Declared label claim
- 10mg
- Laboratory
- PeptideMeter
- Assay date
- 10 Sep 2026
- Submitted
- 19 Sep 2026
- Quarter
- 2026-Q3
- Submitter
- gradient_25
- 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, 28 min gradient, 214 nm | 99.53 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.47 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — linear (open-lactam) precursor (+18 Da) | 0.30 | % 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) | 1023.5408 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.05 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.64 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.47 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.071 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.04 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.50 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.41 | % | — | 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 | Off-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, 28 min gradient | 9.06 | min | 9.24 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.20 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 83,014 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [L-Phe7]-diastereomer | 1.16 | — | 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 | 9.06 | 4,837,467 | 99.53 | — |
| 2 | linear (open-lactam) precursor (+18 Da) | 8.37 | 14,581 | 0.30 | +18.011 |
| 3 | des-acetyl MT-II (−42 Da) | 8.61 | 4,860 | 0.10 | -42.011 |
| 4 | [L-Phe7]-diastereomer | 8.91 | 1,944 | 0.04 | 0.000 |
| 5 | oxidised Trp (+16 Da) | 8.72 | 1,458 | 0.03 | +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 | 342.1875 | 0.0002 | 8.2 |
| 2+ | 512.7774 | 512.7777 | 0.0003 | 57.4 |
| 1+ | 1024.5475 | 1024.5481 | 0.0006 | 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 | 7.04 |
| Counter-ion (acetate) | ion chromatography | 5.50 |
| Residual solvent + inorganic residue | estimated | 0.41 |
| Total peptide content | by difference | 87.05 |
| 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) | 99.74 | 99.53 | divergence +0.23 pp vs batch median |
| Total impurities (% area) | -0.42 | 0.47 | |
| Largest single impurity (% area) | -0.21 | 0.30 | |
| Water (%) | 6.2 | 7.04 | |
| Counter-ion (%) | not stated | 5.50 | |
| Peptide content (%w/w) | not stated | 87.05 | |
| 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, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 10 Sep 2026
- Submitted to the index
- 19 Sep 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 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-P8735 n=8
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042645 | GGPE-2603-P8735 | VendorInvestigate | 2026-Q3 | 98.32 | 7.12 | — | Buyer-sourced | 3 | FAIL |
| AX-2026-042646 | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.80 | 7.04 | 97.3 | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042647 | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.48 | 7.06 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042648 | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042649 | GGPE-2603-P8735 | PeptideMeter | 2026-Q3 | 99.53 | 7.32 | 105.6 | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042650 | GGPE-2603-P8735 | Medutest | 2026-Q3 | 99.86 | 6.49 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042652 | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.36 | 6.96 | — | Supplier-supplied | 4 | MARGINAL |
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-2026-042478 | 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 |
| AX-2026-042652 | GGPeps | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.36 | 6.96 | — | Supplier-supplied | 4 | 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 |