AX-2025-018839
PT-141 (Bremelanotide) · 10 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2505-K8288
- Report ID
- AX-2025-018839
- Compound
- PT-141 (Bremelanotide)
- Compound class
- Melanocortin-receptor peptides
- Supplier
- FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
- Batch / lot
- FGP-2505-K8288
- Declared label claim
- 10mg
- Laboratory
- PeptideMeter
- Assay date
- 20 Nov 2025
- Submitted
- 13 Dec 2025
- Quarter
- 2025-Q4
- Submitter
- Contributor #V-2091
- 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, 28 min gradient, 214 nm | 98.77 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.23 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — linear precursor (+18 Da) | 0.65 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1024.5242 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1024.5240 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.2 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.37 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.26 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 9.97 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 8.899 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 89.0 | % | 90.0 – 110.0 | FAIL |
| Water content | Karl Fischer, coulometric, duplicate | 3.70 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.33 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.60 | % | — | 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 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 | 5.11 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 9.00 | min | 8.94 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.98 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 57,925 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs melanotan II (C-terminal amide, −1 Da) | 1.95 | — | 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 | PT-141 (Bremelanotide) — main peak | 9.00 | 4,800,528 | 98.77 | — |
| 2 | linear precursor (+18 Da) | 8.35 | 31,592 | 0.65 | +18.011 |
| 3 | des-acetyl (−42 Da) | 8.57 | 11,665 | 0.24 | -42.011 |
| 4 | melanotan II (C-terminal amide, −1 Da) | 9.30 | 9,235 | 0.19 | -0.984 |
| 5 | oxidised Trp (+16 Da) | 8.68 | 7,290 | 0.15 | +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 1024.5242 Da, computed from C50H68N14O10. 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+ | 342.5153 | 342.5153 | -0.0000 | 8.9 |
| 2+ | 513.2694 | 513.2693 | -0.0001 | 54.9 |
| 1+ | 1025.5315 | 1025.5313 | -0.0002 | 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 | 3.70 |
| Counter-ion (acetate) | ion chromatography | 5.33 |
| Residual solvent + inorganic residue | estimated | 0.60 |
| Total peptide content | by difference | 90.37 |
| 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) | 98.29 | 98.77 | divergence -0.49 pp vs batch median |
| Total impurities (% area) | 1.71 | 1.23 | |
| Largest single impurity (% area) | not stated | 0.65 | |
| Water (%) | 3.1 | 3.70 | |
| Counter-ion (%) | 3.0 | 5.33 | |
| Peptide content (%w/w) | 93.3 | 90.37 | |
| 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, 13 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 20 Nov 2025
- Submitted to the index
- 13 Dec 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations 3
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 FGP-2505-K8288 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041650 | FGP-2505-K8288 | VendorInvestigate | 2025-Q4 | 98.78 | 3.84 | — | Buyer-sourced | 0 | PASS |
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-2026-041643 | Semaglutide | FGP-2602-M8547 | Janoshik | 2026-Q3 | 99.31 | 2.79 | 100.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041638 | Semaglutide | FGP-2602-M8547 | Janoshik | 2026-Q3 | 99.40 | 2.75 | 105.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041641 | Semaglutide | FGP-2602-M8547 | PeptideMeter | 2026-Q3 | 98.98 | 2.38 | 105.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041610 | Tirzepatide | FGP-2603-L7753 | Janoshik | 2026-Q3 | 98.81 | 2.45 | 101.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041637 | Semaglutide | FGP-2602-M8547 | PeptideMeter | 2026-Q3 | 99.40 | 2.83 | — | Laboratory-retained | 0 | PASS |
| AX-2026-041642 | Semaglutide | FGP-2602-M8547 | PeptideMeter | 2026-Q3 | 98.78 | 2.24 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041609 | Tirzepatide | FGP-2603-L7753 | Janoshik | 2026-Q3 | 98.52 | 2.00 | 98.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041636 | Semaglutide | FGP-2602-M8547 | Nordanalyt | 2026-Q3 | 99.39 | 2.17 | — | Buyer-sourced | 0 | PASS |