AX-2025-018563
Retatrutide · 12 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2412-N4087
- Report ID
- AX-2025-018563
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2412-N4087
- Declared label claim
- 12mg
- Laboratory
- Medutest
- Assay date
- 14 Jan 2025
- Submitted
- 04 Feb 2025
- Quarter
- 2025-Q1
- Submitter
- Contributor #F-2358
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the incretin analogues and co-agonists 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 | 99.17 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.83 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — truncated (5-39) | 0.49 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 4728.5089 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +4.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.59 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.85 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 13.68 | mg | 12 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 12.155 | mg | 12 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 101.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.74 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.08 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.59 | % | — | 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 cake, partially collapsed | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.45 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 17.64 | min | 17.53 ± 0.50 (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 | 37,545 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.49 | — | 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 | Retatrutide — main peak | 17.64 | 4,819,969 | 99.17 | — |
| 2 | truncated (5-39) | 16.04 | 23,816 | 0.49 | -428.201 |
| 3 | [D-Aib2]-diastereomer | 17.46 | 7,290 | 0.15 | 0.000 |
| 4 | retatrutide dimer | 21.07 | 4,374 | 0.09 | +4728.487 |
| 5 | aspartimide (−18 Da) | 18.23 | 2,916 | 0.06 | -18.011 |
| 6 | oxidised Trp (+16 Da) | 17.09 | 1,944 | 0.04 | +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 4728.4871 Da, computed from C221H342N46O68. 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 (%) |
|---|---|---|---|---|
| 7+ | 676.5054 | 676.5085 | 0.0031 | 7.8 |
| 6+ | 789.0885 | 789.0921 | 0.0036 | 49.4 |
| 5+ | 946.7047 | 946.7091 | 0.0044 | 100.0 |
| 4+ | 1183.1291 | 1183.1345 | 0.0054 | 55.2 |
| 3+ | 1577.1696 | 1577.1769 | 0.0073 | 8.0 |
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 | 3.74 |
| Counter-ion (TFA) | ion chromatography | 6.08 |
| Residual solvent + inorganic residue | estimated | 0.59 |
| Total peptide content | by difference | 89.59 |
| 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 | 99.17 | divergence +0.64 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.83 | |
| Largest single impurity (% area) | not stated | 0.49 | |
| Water (%) | 1.5 | 3.74 | |
| Counter-ion (%) | not stated | 6.08 | |
| Peptide content (%w/w) | not stated | 89.59 | |
| Endotoxin (EU/mg) | 0.21 | 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 14 Jan 2025
- Submitted to the index
- 04 Feb 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
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-2412-N4087 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018564 | WWB-2412-N4087 | PeptideMeter | 2025-Q1 | 99.32 | 3.57 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018565 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.12 | 3.07 | 94.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018566 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.93 | 3.38 | 91.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018567 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.16 | 3.64 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018568 | WWB-2412-N4087 | Kestrel | 2025-Q1 | 99.86 | 3.25 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-018569 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.76 | 3.00 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018570 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.15 | 3.36 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018571 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.19 | 3.57 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2025-018572 | WWB-2412-N4087 | Janoshik | 2025-Q1 | 99.93 | 3.66 | 91.6 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043029 | KP | KP-2607-H5219 | Medutest | 2026-Q3 | 95.45 | 5.71 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043030 | KP | KP-2607-H5219 | Kestrel | 2026-Q3 | 95.97 | 6.95 | 97.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-041453 | QYB | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 98.02 | 2.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041454 | QYB | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.84 | 2.77 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041538 | QYB | QYB-2602-G6308 | Medutest | 2026-Q3 | 98.50 | 2.85 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041456 | QYB | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.23 | 3.24 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041452 | QYB | QYB-2604-B5660 | Nordanalyt | 2026-Q3 | 98.50 | 3.36 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043039 | KP | KP-2607-H5219 | Janoshik | 2026-Q3 | 96.14 | 5.62 | — | Supplier-supplied | 2 | FAIL |
| 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 |