AX-2026-041254
Survodutide · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2510-R2141
- Report ID
- AX-2026-041254
- Compound
- Survodutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2510-R2141
- Declared label claim
- 5mg
- Laboratory
- VendorInvestigate
- Assay date
- 30 Jan 2026
- Submitted
- 15 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- h.batista
- 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, 32 min gradient, 214 nm | 99.06 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.94 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — [D-Ser2]-diastereomer | 0.35 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4764.5121 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4764.5102 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.4 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 84.07 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.28 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 6.42 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.347 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 106.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.79 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.61 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.53 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | White powder, no defined cake (melt-back) | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear after 90 s gentle swirling, no particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.73 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 21.40 | min | 21.38 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.07 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 60,866 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Ser2]-diastereomer | 0.78 | — | 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 | Survodutide — main peak | 21.40 | 4,814,623 | 99.06 | — |
| 2 | [D-Ser2]-diastereomer | 21.12 | 17,011 | 0.35 | 0.000 |
| 3 | truncated (2-39) | 19.95 | 14,581 | 0.30 | -137.059 |
| 4 | des-γGlu linker (−129 Da) | 20.39 | 8,263 | 0.17 | -129.043 |
| 5 | aspartimide (−18 Da) | 22.06 | 3,402 | 0.07 | -18.011 |
| 6 | C18 diacid mono-ester | 22.94 | 2,430 | 0.05 | +14.016 |
| 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 4764.5121 Da, computed from C220H340N50O67. 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+ | 681.6519 | 681.6516 | -0.0003 | 7.8 |
| 6+ | 795.0926 | 795.0923 | -0.0003 | 55.6 |
| 5+ | 953.9097 | 953.9093 | -0.0004 | 100.0 |
| 4+ | 1192.1353 | 1192.1348 | -0.0005 | 49.6 |
| 3+ | 1589.1780 | 1589.1773 | -0.0007 | 8.7 |
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 | 5.79 |
| Counter-ion (TFA) | ion chromatography | 9.61 |
| Residual solvent + inorganic residue | estimated | 0.53 |
| Total peptide content | by difference | 84.07 |
| 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) | 99.33 | 99.06 | divergence +0.49 pp vs batch median |
| Total impurities (% area) | 0.67 | 0.94 | |
| Largest single impurity (% area) | 0.25 | 0.35 | |
| Water (%) | 5.1 | 5.79 | |
| Counter-ion (%) | not stated | 9.61 | |
| Peptide content (%w/w) | not stated | 84.07 | |
| Endotoxin (EU/mg) | 0.28 | 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 → third-party forwarder (30 d) → laboratory (courier, cold pack, 7 d) → assay.
- Assay date
- 30 Jan 2026
- Submitted to the index
- 15 Feb 2026
- Laboratory
- VendorInvestigate, Riga, Latvia
- Method basis
- 32 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 WWB-2510-R2141 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041255 | WWB-2510-R2141 | Janoshik | 2026-Q1 | 98.61 | 5.74 | 91.2 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042547 | ERP | ERP-2605-E7682 | PeptideMeter | 2026-Q3 | 98.25 | 5.44 | 93.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042548 | ERP | ERP-2605-E7682 | Janoshik | 2026-Q3 | 97.92 | 5.96 | 92.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042546 | ERP | ERP-2605-E7682 | Janoshik | 2026-Q3 | 98.01 | 5.78 | 105.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042549 | ERP | ERP-2605-E7682 | Janoshik | 2026-Q3 | 98.73 | 5.51 | 91.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042728 | GGPeps | GGPE-2512-Y9921 | PeptideMeter | 2026-Q2 | 97.83 | 4.12 | 98.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042730 | GGPeps | GGPE-2512-Y9921 | PeptideMeter | 2026-Q2 | 97.74 | 3.68 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042729 | GGPeps | GGPE-2512-Y9921 | Janoshik | 2026-Q2 | 97.37 | 3.51 | 99.0 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-042727 | GGPeps | GGPE-2512-Y9921 | Nordanalyt | 2026-Q2 | 97.45 | 3.38 | — | Supplier-supplied | 1 | MARGINAL |
| 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 |