AX-2025-021130
Semaglutide · 3 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2509-A5382
MARGINALPURITY ONLY
- Report ID
- AX-2025-021130
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2509-A5382
- Declared label claim
- 3mg
- Laboratory
- Medutest
- Assay date
- 05 Oct 2025
- Submitted
- 07 Oct 2025
- Quarter
- 2025-Q4
- Submitter
- h.yilmaz
- Sample provenance
- Supplier-supplied
Section 1
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 | 99.06 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.94 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — des-His1 truncate (−137 Da) | 0.51 | % 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 | 85.01 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.21 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 3.60 | mg | 3 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 3.032 | mg | 3 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 101.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.06 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 8.76 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.17 | % | — | 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 | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.82 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 15.78 | min | 15.60 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.37 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 57,435 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.74 | — | no index criterion | REPORTED |
Section 2
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 | 15.78 | 4,814,623 | 99.06 | — |
| 2 | des-His1 truncate (−137 Da) | 14.83 | 24,788 | 0.51 | -137.059 |
| 3 | C18 diacid mono-ester | 16.91 | 9,721 | 0.20 | +14.016 |
| 4 | Met(O) sulfoxide (+16 Da) | 15.21 | 7,776 | 0.16 | +15.995 |
| 5 | deamidated (Asn→Asp, +1 Da) | 15.35 | 2,430 | 0.05 | +0.984 |
| 6 | [D-Aib8]-diastereomer | 15.58 | 972 | 0.02 | 0.000 |
| 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.
Section 4
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 | 6.06 |
| Counter-ion (TFA) | ion chromatography | 8.76 |
| Residual solvent + inorganic residue | estimated | 0.17 |
| Total peptide content | by difference | 85.01 |
| 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) | 98.37 | 99.06 | divergence +0.32 pp vs batch median |
| Total impurities (% area) | 1.63 | 0.94 | |
| Largest single impurity (% area) | 1.17 | 0.51 | |
| Water (%) | 4.8 | 6.06 | |
| Counter-ion (%) | not stated | 8.76 | |
| Peptide content (%w/w) | not stated | 85.01 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
Section 5
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, 3 d) → assay. Submitter did not handle the vial.
- Assay date
- 05 Oct 2025
- Submitted to the index
- 07 Oct 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot WXT-2509-A5382 n=16
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021122 | WXT-2509-A5382 | PeptideMeter | 2025-Q4 | 97.33 | 6.32 | 107.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043462 | WXT-2509-A5382 | PeptideMeter | 2025-Q4 | 98.74 | 6.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021123 | WXT-2509-A5382 | VendorInvestigate | 2025-Q4 | 97.94 | 6.64 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043463 | WXT-2509-A5382 | Kestrel | 2025-Q4 | 99.29 | 6.83 | 94.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021124 | WXT-2509-A5382 | Kestrel | 2025-Q4 | 99.17 | 6.76 | — | Buyer-sourced | 2 | FAIL |
| AX-2025-021125 | WXT-2509-A5382 | Janoshik | 2025-Q4 | 98.03 | 6.11 | 93.3 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021126 | WXT-2509-A5382 | Medutest | 2025-Q4 | 97.82 | 6.09 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021127 | WXT-2509-A5382 | VendorInvestigate | 2025-Q4 | 97.58 | 6.52 | 96.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021128 | WXT-2509-A5382 | Janoshik | 2025-Q4 | 97.87 | 6.61 | 104.1 | Laboratory-retained | 1 | MARGINAL |
| AX-2025-021129 | WXT-2509-A5382 | Janoshik | 2025-Q4 | 98.07 | 6.86 | 95.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021131 | WXT-2509-A5382 | Janoshik | 2025-Q4 | 98.41 | 6.17 | 102.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021132 | WXT-2509-A5382 | Janoshik | 2025-Q4 | 98.22 | 5.85 | 105.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021133 | WXT-2509-A5382 | Medutest | 2025-Q4 | 98.01 | 6.29 | 104.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-021134 | WXT-2509-A5382 | VendorInvestigate | 2025-Q4 | 97.37 | 5.55 | 96.3 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021135 | WXT-2509-A5382 | Janoshik | 2025-Q4 | 98.16 | 6.77 | 104.4 | Supplier-supplied | 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-2026-043488 | Pramlintide | WXT-2603-D6052 | Janoshik | 2026-Q3 | 97.87 | 4.37 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043406 | Semaglutide | WXT-2604-C4728 | Janoshik | 2026-Q3 | 97.24 | 4.65 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043421 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.15 | 3.09 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043420 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.62 | 3.07 | 96.4 | Supplier-supplied | 0 | PASS |
| AX-2026-043423 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.28 | 3.86 | 98.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043401 | Semaglutide | WXT-2604-C4728 | Medutest | 2026-Q3 | 97.70 | 4.78 | 91.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043400 | Semaglutide | WXT-2604-C4728 | Nordanalyt | 2026-Q3 | 96.86 | 4.11 | 106.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-043422 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.35 | 3.59 | — | Supplier-supplied | 1 | MARGINAL |