AX-2026-041410
PT-141 (Bremelanotide) · 10 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2509-A4716
- Report ID
- AX-2026-041410
- Compound
- PT-141 (Bremelanotide)
- Compound class
- Melanocortin-receptor peptides
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2509-A4716
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 20 Jan 2026
- Submitted
- 26 Jan 2026
- Quarter
- 2026-Q1
- Submitter
- quarter_over_quarter
- 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, 25 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 — oxidised Trp (+16 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 | 87.70 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.64 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.62 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.307 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 93.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.54 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.21 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.55 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.26 | 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 | Off-white lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Visible particulates, did not clear | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.88 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 7.95 | min | 8.06 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.01 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 78,578 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs oxidised Trp (+16 Da) | 2.44 | — | 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 | 7.95 | 4,856,908 | 99.93 | — |
| 2 | oxidised Trp (+16 Da) | 7.67 | 1,944 | 0.04 | +15.995 |
| 3 | linear precursor (+18 Da) | 7.37 | 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 | 5.54 |
| Counter-ion (acetate) | ion chromatography | 6.21 |
| Residual solvent + inorganic residue | estimated | 0.55 |
| Total peptide content | by difference | 87.70 |
| 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) | not stated | 0.04 | |
| Water (%) | not stated | 5.54 | |
| Counter-ion (%) | 3.7 | 6.21 | |
| Peptide content (%w/w) | 92.2 | 87.70 | |
| Endotoxin (EU/mg) | not stated | 0.26 | |
| 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
- 20 Jan 2026
- Submitted to the index
- 26 Jan 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot WWB-2509-A4716 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041407 | WWB-2509-A4716 | PeptideMeter | 2026-Q1 | 99.93 | 5.02 | 88.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041408 | WWB-2509-A4716 | Janoshik | 2026-Q1 | 99.93 | 4.83 | 89.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041409 | WWB-2509-A4716 | Medutest | 2026-Q1 | 99.90 | 4.83 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-041411 | WWB-2509-A4716 | Medutest | 2026-Q1 | 99.93 | 5.33 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041412 | WWB-2509-A4716 | Medutest | 2026-Q1 | 99.93 | 4.11 | 102.2 | Laboratory-retained | 0 | PASS |
| AX-2026-041413 | WWB-2509-A4716 | Medutest | 2026-Q1 | 99.76 | 5.27 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041414 | WWB-2509-A4716 | Janoshik | 2026-Q1 | 99.70 | 4.70 | 104.6 | Supplier-supplied | 0 | PASS |
| AX-2026-041415 | WWB-2509-A4716 | PeptideMeter | 2026-Q1 | 99.49 | 5.76 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041416 | WWB-2509-A4716 | Janoshik | 2026-Q1 | 99.93 | 4.77 | 88.6 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-041417 | WWB-2509-A4716 | Janoshik | 2026-Q1 | 99.93 | 4.57 | 97.6 | 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-2026-041275 | Liraglutide | WWB-2607-X2189 | Nordanalyt | 2026-Q3 | 99.61 | 5.03 | 97.3 | Supplier-supplied | 0 | PASS |
| AX-2026-041387 | BPC-157 | WWB-2606-H3906 | Janoshik | 2026-Q3 | 98.95 | 4.64 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-041334 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.83 | 5.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041337 | Semaglutide | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 98.96 | 4.81 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041385 | BPC-157 | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.31 | 4.31 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041390 | BPC-157 | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.47 | 4.84 | 99.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041386 | BPC-157 | WWB-2606-H3906 | VendorInvestigate | 2026-Q3 | 99.32 | 4.88 | 99.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041335 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 99.55 | 4.55 | 100.5 | Supplier-supplied | 1 | MARGINAL |