AX-2026-041359
Semaglutide · 10 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2508-S3298
- Report ID
- AX-2026-041359
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2508-S3298
- Declared label claim
- 10mg
- Laboratory
- VendorInvestigate
- Assay date
- 14 Mar 2026
- Submitted
- 20 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- g.zielinski
- 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 | 98.71 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.29 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — deamidated (Asn→Asp, +1 Da) | 0.64 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4111.0524 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4111.0392 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -3.2 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.75 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.64 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.72 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.920 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.29 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.47 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.49 | % | — | 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 | Slow dissolution, >5 min to clarity | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.23 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 19.50 | min | 19.55 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.27 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 64,338 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.81 | — | 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 | Semaglutide — main peak | 19.50 | 4,797,612 | 98.71 | — |
| 2 | deamidated (Asn→Asp, +1 Da) | 18.96 | 31,106 | 0.64 | +0.984 |
| 3 | [D-Aib8]-diastereomer | 19.24 | 17,497 | 0.36 | 0.000 |
| 4 | des-AEEA semaglutide (−145 Da) | 18.63 | 9,235 | 0.19 | -145.074 |
| 5 | Met(O) sulfoxide (+16 Da) | 18.77 | 2,916 | 0.06 | +15.995 |
| 6 | C18 diacid mono-ester | 20.95 | 972 | 0.02 | +14.016 |
| 7 | semaglutide dimer | 23.46 | 972 | 0.02 | +4111.052 |
| 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 4111.0524 Da, computed from C187H291N45O59. 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 (%) |
|---|---|---|---|---|
| 6+ | 686.1827 | 686.1805 | -0.0022 | 8.4 |
| 5+ | 823.2178 | 823.2151 | -0.0027 | 54.4 |
| 4+ | 1028.7704 | 1028.7671 | -0.0033 | 100.0 |
| 3+ | 1371.3581 | 1371.3537 | -0.0044 | 50.9 |
| 2+ | 2056.5335 | 2056.5269 | -0.0066 | 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 | 4.29 |
| Counter-ion (TFA) | ion chromatography | 9.47 |
| Residual solvent + inorganic residue | estimated | 0.49 |
| Total peptide content | by difference | 85.75 |
| 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 | 98.71 | divergence +0.89 pp vs batch median |
| Total impurities (% area) | not stated | 1.29 | |
| Largest single impurity (% area) | not stated | 0.64 | |
| Water (%) | 3.6 | 4.29 | |
| Counter-ion (%) | not stated | 9.47 | |
| Peptide content (%w/w) | not stated | 85.75 | |
| Endotoxin (EU/mg) | 0.21 | 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (−20 °C, 4 d) → laboratory (courier, dry ice, 9 d) → assay.
- Assay date
- 14 Mar 2026
- Submitted to the index
- 20 Mar 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-2508-S3298 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041356 | WWB-2508-S3298 | VendorInvestigate | 2026-Q1 | 99.11 | 4.56 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041357 | WWB-2508-S3298 | Janoshik | 2026-Q1 | 98.90 | 4.86 | 103.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041358 | WWB-2508-S3298 | Janoshik | 2026-Q1 | 99.41 | 5.01 | 103.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041360 | WWB-2508-S3298 | PeptideMeter | 2026-Q1 | 99.77 | 4.50 | 90.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041361 | WWB-2508-S3298 | VendorInvestigate | 2026-Q1 | 98.49 | 4.90 | 90.4 | Buyer-sourced | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041334 | WWB | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.83 | 5.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041932 | TFC | TFC-2604-X4301 | Janoshik | 2026-Q3 | 98.88 | 4.31 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042347 | HJ | HJ-2608-C3931 | VendorInvestigate | 2026-Q3 | 98.80 | 3.41 | 100.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041886 | JEEP | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.19 | 4.03 | 96.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041337 | WWB | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 98.96 | 4.81 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042172 | Homopeptide | HOMO-2604-X8921 | Janoshik | 2026-Q3 | 99.64 | 5.16 | 91.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041767 | FGP | FGP-2602-M1508 | PeptideMeter | 2026-Q3 | 98.65 | 2.54 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-041882 | JEEP | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.17 | 4.52 | — | 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 |