AX-2026-042477
Melanotan II · 10 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2603-A5707
- Report ID
- AX-2026-042477
- Compound
- Melanotan II
- Compound class
- Melanocortin-receptor peptides
- Supplier
- SWB — Shanghai Wibson Biotechnology Co., Ltd.
- Batch / lot
- SWB-2603-A5707
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 18 Jul 2026
- Submitted
- 22 Jul 2026
- Quarter
- 2026-Q3
- Submitter
- s.nilsen
- 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, 25 min gradient, 214 nm | 98.87 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.13 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-acetyl MT-II (−42 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, unit resolution (single quadrupole) | 1023.5410 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 91.43 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 90.40 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.46 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.360 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 103.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.52 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.73 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.32 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.50 | 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 powder, no defined cake (melt-back) | — | 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 | 5.73 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 8.32 | min | 8.33 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.92 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 59,053 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [L-Phe7]-diastereomer | 0.95 | — | 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 | 8.32 | 4,805,388 | 98.87 | — |
| 2 | des-acetyl MT-II (−42 Da) | 7.92 | 21,871 | 0.45 | -42.011 |
| 3 | linear (open-lactam) precursor (+18 Da) | 7.70 | 19,927 | 0.41 | +18.011 |
| 4 | MT-II dimer (head-to-tail) | 10.28 | 6,804 | 0.14 | +1023.540 |
| 5 | [L-Phe7]-diastereomer | 8.19 | 3,402 | 0.07 | 0.000 |
| 6 | oxidised Trp (+16 Da) | 8.02 | 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 | 342.1876 | 0.0003 | 8.2 |
| 2+ | 512.7774 | 512.7778 | 0.0004 | 52.0 |
| 1+ | 1024.5475 | 1024.5483 | 0.0008 | 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 | 4.52 |
| Counter-ion (acetate) | ion chromatography | 3.73 |
| Residual solvent + inorganic residue | estimated | 0.32 |
| Total peptide content | by difference | 91.43 |
| 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) | 99.71 | 98.87 | divergence +0.55 pp vs batch median |
| Total impurities (% area) | 0.29 | 1.13 | |
| Largest single impurity (% area) | 0.12 | 0.45 | |
| Water (%) | 3.0 | 4.52 | |
| Counter-ion (%) | 9.3 | 3.73 | |
| Peptide content (%w/w) | 87.1 | 91.43 | |
| Endotoxin (EU/mg) | not stated | 1.50 | |
| 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, 25 d) → laboratory (hand-carried, 12 d) → assay.
- Assay date
- 18 Jul 2026
- Submitted to the index
- 22 Jul 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot SWB-2603-A5707 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042472 | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.55 | 4.28 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042473 | SWB-2603-A5707 | PeptideMeter | 2026-Q3 | 99.37 | 3.75 | 96.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042474 | SWB-2603-A5707 | Medutest | 2026-Q3 | 99.35 | 4.29 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042475 | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.42 | 4.21 | 105.7 | Supplier-supplied | 0 | PASS |
| AX-2026-042476 | SWB-2603-A5707 | VendorInvestigate | 2026-Q3 | 98.25 | 3.86 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042478 | SWB-2603-A5707 | VendorInvestigate | 2026-Q3 | 98.73 | 4.34 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042479 | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.16 | 3.67 | 94.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042480 | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.03 | 4.05 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042481 | SWB-2603-A5707 | Medutest | 2026-Q3 | 98.95 | 3.37 | 90.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042482 | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.22 | 4.66 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042483 | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.38 | 3.73 | 107.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042484 | SWB-2603-A5707 | PeptideMeter | 2026-Q3 | 98.90 | 3.53 | 101.5 | Buyer-sourced | 1 | 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-2026-042651 | 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-2026-042461 | Kisspeptin-10 | SWB-2603-D6238 | Janoshik | 2026-Q3 | 98.35 | 4.65 | 96.5 | Supplier-supplied | 3 | FAIL |
| AX-2026-042479 | Melanotan II | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.16 | 3.67 | 94.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042481 | Melanotan II | SWB-2603-A5707 | Medutest | 2026-Q3 | 98.95 | 3.37 | 90.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042460 | Kisspeptin-10 | SWB-2603-D6238 | Kestrel | 2026-Q3 | 99.55 | 4.21 | 90.8 | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042483 | Melanotan II | SWB-2603-A5707 | Janoshik | 2026-Q3 | 99.38 | 3.73 | 107.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042398 | Semaglutide | SWB-2602-X5278 | Nordanalyt | 2026-Q3 | 99.08 | 4.48 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042399 | Semaglutide | SWB-2602-X5278 | Janoshik | 2026-Q3 | 98.56 | 3.82 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042499 | BPC-157 | SWB-2607-Y5787 | Kestrel | 2026-Q3 | 99.93 | 4.25 | 94.4 | Supplier-supplied | 0 | PASS |