AX-2026-043599
Melanotan II · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2511-P5567
- Report ID
- AX-2026-043599
- Compound
- Melanotan II
- Compound class
- Melanocortin-receptor peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2511-P5567
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 25 Feb 2026
- Submitted
- 26 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- n.okonkwo
- 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 | 99.13 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.87 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — [L-Phe7]-diastereomer | 0.48 | % 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) | 1023.5428 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +2.5 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.60 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.81 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.15 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.014 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.10 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.93 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.37 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.40 | 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 | 4.96 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.91 | min | 9.84 ± 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 | 36,118 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [L-Phe7]-diastereomer | 0.75 | — | 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 | 9.91 | 4,818,025 | 99.13 | — |
| 2 | [L-Phe7]-diastereomer | 9.75 | 23,329 | 0.48 | 0.000 |
| 3 | linear (open-lactam) precursor (+18 Da) | 9.17 | 9,235 | 0.19 | +18.011 |
| 4 | oxidised Trp (+16 Da) | 9.55 | 5,346 | 0.11 | +15.995 |
| 5 | des-acetyl MT-II (−42 Da) | 9.43 | 2,430 | 0.05 | -42.011 |
| 6 | MT-II dimer (head-to-tail) | 12.26 | 1,944 | 0.04 | +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 | 342.1882 | 0.0009 | 8.3 |
| 2+ | 512.7774 | 512.7787 | 0.0013 | 53.2 |
| 1+ | 1024.5475 | 1024.5501 | 0.0026 | 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 | 4.10 |
| Counter-ion (acetate) | ion chromatography | 4.93 |
| Residual solvent + inorganic residue | estimated | 0.37 |
| Total peptide content | by difference | 90.60 |
| 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) | 99.33 | 99.13 | divergence -0.13 pp vs batch median |
| Total impurities (% area) | -0.16 | 0.87 | |
| Largest single impurity (% area) | not stated | 0.48 | |
| Water (%) | not stated | 4.10 | |
| Counter-ion (%) | not stated | 4.93 | |
| Peptide content (%w/w) | 91.7 | 90.60 | |
| Endotoxin (EU/mg) | not stated | 0.40 | |
| 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 → third-party forwarder (3 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 25 Feb 2026
- Submitted to the index
- 26 Feb 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations 2
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Related records
Same batch — lot WXT-2511-P5567 n=8
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043594 | WXT-2511-P5567 | Janoshik | 2026-Q1 | 99.38 | 4.20 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043595 | WXT-2511-P5567 | Janoshik | 2026-Q1 | 99.93 | 4.05 | 100.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043596 | WXT-2511-P5567 | Janoshik | 2026-Q1 | 99.54 | 4.20 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-043597 | WXT-2511-P5567 | Nordanalyt | 2026-Q1 | 99.28 | 4.15 | 88.8 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043598 | WXT-2511-P5567 | Kestrel | 2026-Q1 | 99.93 | 4.29 | 91.7 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043600 | WXT-2511-P5567 | Janoshik | 2026-Q1 | 99.45 | 4.41 | 98.7 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043601 | WXT-2511-P5567 | Nordanalyt | 2026-Q1 | 99.46 | 3.63 | — | Laboratory-retained | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042691 | SWB | SWB-2603-A7409 | Kestrel | 2026-Q3 | 99.60 | 4.39 | 90.5 | Laboratory-retained | 0 | PASS |
| AX-2026-042692 | SWB | SWB-2603-A7409 | Janoshik | 2026-Q3 | 99.73 | 3.66 | 94.9 | Supplier-supplied | 0 | PASS |
| AX-2026-042687 | SWB | SWB-2603-A7409 | Nordanalyt | 2026-Q3 | 99.05 | 4.33 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042693 | SWB | SWB-2603-A7409 | Janoshik | 2026-Q3 | 99.93 | 4.63 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042686 | SWB | SWB-2603-A7409 | PeptideMeter | 2026-Q3 | 99.69 | 4.52 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042685 | SWB | SWB-2603-A7409 | Janoshik | 2026-Q3 | 99.03 | 4.35 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042694 | SWB | SWB-2603-A7409 | PeptideMeter | 2026-Q3 | 99.21 | 3.84 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042684 | SWB | SWB-2603-A7409 | Janoshik | 2026-Q3 | 99.01 | 3.41 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043651 | Pramlintide | WXT-2603-D6459 | PeptideMeter | 2026-Q3 | 98.21 | 4.97 | 101.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043531 | Leuprolide | WXT-2604-K4483 | Medutest | 2026-Q3 | 99.00 | 5.03 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043561 | Semaglutide | WXT-2604-C5135 | Janoshik | 2026-Q3 | 96.96 | 4.22 | 91.3 | Buyer-sourced | 0 | FAIL |
| AX-2026-043627 | L-Glutathione (reduced) | WXT-2605-B5720 | Janoshik | 2026-Q3 | 97.96 | 6.08 | 92.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043564 | Semaglutide | WXT-2604-C5135 | Janoshik | 2026-Q3 | 97.15 | 4.44 | 104.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043533 | Leuprolide | WXT-2604-K4483 | PeptideMeter | 2026-Q3 | 99.89 | 4.94 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043624 | L-Glutathione (reduced) | WXT-2605-B5720 | Nordanalyt | 2026-Q3 | 98.18 | 6.95 | 105.3 | Buyer-sourced | 2 | FAIL |
| AX-2026-043556 | Semaglutide | WXT-2604-C5135 | PeptideMeter | 2026-Q3 | 97.56 | 4.35 | 89.6 | Buyer-sourced | 1 | MARGINAL |