AX-2026-042475
PT-141 (Bremelanotide) · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2512-V4503
- Report ID
- AX-2026-042475
- Compound
- PT-141 (Bremelanotide)
- Compound class
- Melanocortin-receptor peptides
- Supplier
- Homopeptide — Hunan Aslsen Technology Co., Ltd.
- Batch / lot
- HOMO-2512-V4503
- Declared label claim
- 10mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 04 Mar 2026
- Submitted
- 07 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- f.grimaldi
- 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, 15 min gradient, 214 nm | 99.93 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.07 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-acetyl (−42 Da) | 0.04 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 90.91 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 90.85 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.42 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.375 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 103.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.52 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.05 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.52 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.27 | 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 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 | 5.48 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 5.23 | min | 5.14 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.19 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 72,590 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs des-acetyl (−42 Da) | 2.89 | — | 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 | PT-141 (Bremelanotide) — main peak | 5.23 | 4,856,908 | 99.93 | — |
| 2 | des-acetyl (−42 Da) | 5.00 | 1,944 | 0.04 | -42.011 |
| 3 | linear precursor (+18 Da) | 4.88 | 1,458 | 0.03 | +18.011 |
| 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.
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 | 4.05 |
| Residual solvent + inorganic residue | estimated | 0.52 |
| Total peptide content | by difference | 90.91 |
| 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) | 99.90 | 99.93 | divergence -0.03 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.07 | |
| Largest single impurity (% area) | 0.04 | 0.04 | |
| Water (%) | 3.8 | 4.52 | |
| Counter-ion (%) | not stated | 4.05 | |
| Peptide content (%w/w) | not stated | 90.91 | |
| Endotoxin (EU/mg) | 0.26 | 0.27 | |
| 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 (−20 °C, 31 d) → laboratory (courier, dry ice, 8 d) → assay.
- Assay date
- 04 Mar 2026
- Submitted to the index
- 07 Mar 2026
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- METHOD LIMITED
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 HOMO-2512-V4503 n=1
This is the only report on this lot. One report is not a batch characterisation.
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041471 | QYB | QYB-2607-L4875 | Janoshik | 2026-Q3 | 99.72 | 3.75 | 101.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041473 | QYB | QYB-2607-L4875 | PeptideMeter | 2026-Q3 | 99.58 | 3.74 | 94.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041472 | QYB | QYB-2607-L4875 | PeptideMeter | 2026-Q3 | 99.93 | 3.94 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041474 | QYB | QYB-2607-L4875 | VendorInvestigate | 2026-Q3 | 99.16 | 3.78 | 95.6 | Buyer-sourced | 0 | PASS |
| AX-2026-041470 | QYB | QYB-2607-L4875 | Janoshik | 2026-Q3 | 99.77 | 4.10 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042139 | JEEP | JEEP-2601-K8195 | VendorInvestigate | 2026-Q2 | 98.32 | 4.29 | 99.4 | Buyer-sourced | 1 | FAIL |
| AX-2026-041964 | AMB | AMB-2601-M5602 | Janoshik | 2026-Q2 | 99.93 | 3.20 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041664 | FGP | FGP-2602-Y8741 | Janoshik | 2026-Q2 | 99.90 | 4.48 | 106.5 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042437 | Retatrutide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042424 | Semaglutide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042503 | IGF-1 LR3 | HOMO-2607-P5131 | Janoshik | 2026-Q3 | 99.36 | 5.99 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042492 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Medutest | 2026-Q3 | 99.93 | 2.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042491 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 3.24 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042473 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.01 | 5.00 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042441 | Retatrutide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042474 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.18 | 5.44 | — | Buyer-sourced | 0 | PASS |