AX-2026-041243
Retatrutide · 30 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2510-H1662
- Report ID
- AX-2026-041243
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2510-H1662
- Declared label claim
- 30mg
- Laboratory
- Janoshik Analytical
- Assay date
- 09 Jan 2026
- Submitted
- 23 Jan 2026
- Quarter
- 2026-Q1
- Submitter
- k.petrescu
- Sample provenance
- Buyer-sourced
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, 30 min gradient, 214 nm | 99.05 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.95 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — des-Aib20 analogue | 0.41 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4728.5107 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.0 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.25 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.41 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 36.05 | mg | 30 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 31.511 | mg | 30 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.77 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.01 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.97 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.71 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| 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 | Slow dissolution, >5 min to clarity | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.56 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 19.89 | min | 20.71 ± 0.50 (normalised) | FAIL |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.95 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 68,013 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.70 | — | 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 | 19.89 | 4,814,137 | 99.05 | — |
| 2 | des-Aib20 analogue | 19.45 | 19,927 | 0.41 | -85.053 |
| 3 | [D-Aib2]-diastereomer | 19.67 | 13,609 | 0.28 | 0.000 |
| 4 | truncated (5-39) | 17.97 | 7,776 | 0.16 | -428.201 |
| 5 | oxidised Trp (+16 Da) | 19.23 | 2,430 | 0.05 | +15.995 |
| 6 | retatrutide dimer | 24.01 | 2,430 | 0.05 | +4728.487 |
| 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 | 676.5088 | 0.0034 | 9.2 |
| 6+ | 789.0885 | 789.0924 | 0.0039 | 53.2 |
| 5+ | 946.7047 | 946.7094 | 0.0047 | 100.0 |
| 4+ | 1183.1291 | 1183.1350 | 0.0059 | 56.2 |
| 3+ | 1577.1696 | 1577.1775 | 0.0079 | 8.6 |
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 | 4.77 |
| Counter-ion (TFA) | ion chromatography | 6.01 |
| Residual solvent + inorganic residue | estimated | 0.97 |
| Total peptide content | by difference | 88.25 |
| 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) | 99.34 | 99.05 | divergence +0.07 pp vs batch median |
| Total impurities (% area) | not stated | 0.95 | |
| Largest single impurity (% area) | not stated | 0.41 | |
| Water (%) | 4.2 | 4.77 | |
| Counter-ion (%) | not stated | 6.01 | |
| Peptide content (%w/w) | not stated | 88.25 | |
| Endotoxin (EU/mg) | 1.09 | 0.71 | |
| 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, 19 d) → laboratory (hand-carried, 10 d) → assay.
- Assay date
- 09 Jan 2026
- Submitted to the index
- 23 Jan 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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 WWB-2510-H1662 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041234 | WWB-2510-H1662 | PeptideMeter | 2026-Q1 | 99.50 | 4.46 | 99.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041235 | WWB-2510-H1662 | Janoshik | 2026-Q1 | 99.13 | 4.71 | 98.6 | Buyer-sourced | 0 | PASS |
| AX-2026-041236 | WWB-2510-H1662 | Janoshik | 2026-Q1 | 99.36 | 5.05 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041237 | WWB-2510-H1662 | Janoshik | 2026-Q1 | 99.45 | 4.60 | 107.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041238 | WWB-2510-H1662 | PeptideMeter | 2026-Q1 | 99.27 | 4.62 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041239 | WWB-2510-H1662 | Janoshik | 2026-Q1 | 99.68 | 5.00 | 103.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041240 | WWB-2510-H1662 | PeptideMeter | 2026-Q1 | 98.96 | 4.70 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041241 | WWB-2510-H1662 | Janoshik | 2026-Q1 | 99.10 | 4.83 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041242 | WWB-2510-H1662 | Kestrel | 2026-Q1 | 99.93 | 4.97 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041244 | WWB-2510-H1662 | Janoshik | 2026-Q1 | 99.14 | 4.83 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042437 | Homopeptide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043095 | KP | KP-2607-H5774 | Janoshik | 2026-Q3 | 95.81 | 5.48 | 105.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-042282 | TFC | TFC-2608-J1156 | Janoshik | 2026-Q3 | 98.54 | 4.27 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043094 | KP | KP-2607-H5774 | PeptideMeter | 2026-Q3 | 96.32 | 6.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042441 | Homopeptide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041427 | QYB | QYB-2604-B4920 | PeptideMeter | 2026-Q3 | 97.93 | 2.45 | 101.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041786 | ASY | ASY-{CAT}-2288 | VendorInvestigate | 2026-Q3 | 98.78 | 6.59 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041428 | QYB | QYB-2604-B4920 | Janoshik | 2026-Q3 | 98.35 | 3.20 | — | Laboratory-retained | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041275 | Liraglutide | WWB-2607-X2189 | Nordanalyt | 2026-Q3 | 99.33 | 4.39 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041334 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.93 | 4.62 | 99.9 | Buyer-sourced | 0 | PASS |
| AX-2026-041337 | Semaglutide | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 99.52 | 3.92 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041335 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 99.15 | 4.27 | 98.9 | Buyer-sourced | 0 | PASS |
| AX-2026-041271 | Liraglutide | WWB-2607-X2189 | Medutest | 2026-Q3 | 99.52 | 4.57 | 97.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041328 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.99 | 4.47 | 106.1 | Buyer-sourced | 0 | PASS |
| AX-2026-041333 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 99.18 | 4.51 | 90.4 | Laboratory-retained | 0 | PASS |
| AX-2026-041273 | Liraglutide | WWB-2607-X2189 | Janoshik | 2026-Q3 | 99.31 | 5.52 | 104.8 | Buyer-sourced | 1 | MARGINAL |