AX-2026-041919
PT-141 (Bremelanotide) · 10 mg declared · Guangzhou JEEP Biotechnology Co., Ltd. · lot JEEP-2603-G4602
- Report ID
- AX-2026-041919
- Compound
- PT-141 (Bremelanotide)
- Compound class
- Melanocortin-receptor peptides
- Supplier
- JEEP — Guangzhou JEEP Biotechnology Co., Ltd.
- Batch / lot
- JEEP-2603-G4602
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 05 Apr 2026
- Submitted
- 24 Apr 2026
- Quarter
- 2026-Q2
- Submitter
- c.ekstrom
- 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, 30 min gradient, 214 nm | 99.28 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.72 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — linear precursor (+18 Da) | 0.47 | % 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) | 1024.5298 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.5 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.55 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.91 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.96 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.514 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.31 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.63 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.51 | % | — | 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 | 5.23 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.54 | min | 9.52 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.14 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 59,476 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs melanotan II (C-terminal amide, −1 Da) | 2.00 | — | 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 | 9.54 | 4,825,316 | 99.28 | — |
| 2 | linear precursor (+18 Da) | 8.84 | 22,843 | 0.47 | +18.011 |
| 3 | oxidised Trp (+16 Da) | 9.20 | 7,290 | 0.15 | +15.995 |
| 4 | des-acetyl (−42 Da) | 9.08 | 2,916 | 0.06 | -42.011 |
| 5 | melanotan II (C-terminal amide, −1 Da) | 9.86 | 1,944 | 0.04 | -0.984 |
| 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 | 342.5172 | 0.0019 | 8.3 |
| 2+ | 513.2694 | 513.2722 | 0.0028 | 52.6 |
| 1+ | 1025.5315 | 1025.5371 | 0.0056 | 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 | 5.31 |
| Counter-ion (acetate) | ion chromatography | 5.63 |
| Residual solvent + inorganic residue | estimated | 0.51 |
| Total peptide content | by difference | 88.55 |
| 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 | 99.28 | divergence +0.38 pp vs batch median |
| Total impurities (% area) | not stated | 0.72 | |
| Largest single impurity (% area) | not stated | 0.47 | |
| Water (%) | not stated | 5.31 | |
| Counter-ion (%) | not stated | 5.63 | |
| Peptide content (%w/w) | 91.7 | 88.55 | |
| Endotoxin (EU/mg) | 0.28 | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 5 d) → assay. Submitter did not handle the vial.
- Assay date
- 05 Apr 2026
- Submitted to the index
- 24 Apr 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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 JEEP-2603-G4602 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041920 | JEEP-2603-G4602 | Nordanalyt | 2026-Q2 | 99.75 | 5.75 | 100.5 | Supplier-supplied | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041488 | QYB | QYB-2607-L5615 | Janoshik | 2026-Q3 | 99.93 | 3.79 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041483 | QYB | QYB-2607-L5615 | Janoshik | 2026-Q3 | 99.93 | 3.87 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041482 | QYB | QYB-2607-L5615 | PeptideMeter | 2026-Q3 | 99.41 | 3.97 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041489 | QYB | QYB-2607-L5615 | PeptideMeter | 2026-Q3 | 99.40 | 4.39 | 90.1 | Supplier-supplied | 0 | PASS |
| AX-2026-041480 | QYB | QYB-2607-L5615 | Medutest | 2026-Q3 | 99.93 | 4.32 | 100.5 | Supplier-supplied | 0 | PASS |
| AX-2026-041481 | QYB | QYB-2607-L5615 | Kestrel | 2026-Q3 | 99.93 | 3.63 | 100.5 | Supplier-supplied | 0 | PASS |
| AX-2026-041487 | QYB | QYB-2607-L5615 | Nordanalyt | 2026-Q3 | 99.43 | 4.03 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041486 | QYB | QYB-2607-L5615 | Nordanalyt | 2026-Q3 | 99.62 | 3.82 | 104.9 | Supplier-supplied | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041847 | TB-500 | JEEP-2602-V3434 | Nordanalyt | 2026-Q3 | 99.72 | 3.85 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041886 | Semaglutide | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.19 | 4.03 | 96.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041882 | Semaglutide | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.17 | 4.52 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041845 | TB-500 | JEEP-2602-V3434 | Janoshik | 2026-Q3 | 99.72 | 4.04 | 102.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041921 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.90 | 1.76 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041922 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.41 | 2.60 | 95.7 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041928 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.88 | 1.84 | 92.8 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041849 | TB-500 | JEEP-2602-V3434 | VendorInvestigate | 2026-Q3 | 99.73 | 3.60 | 88.6 | Buyer-sourced | 2 | MARGINAL |