AX-2025-020634
Semaglutide · 2 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2510-C7247
MARGINALVERIFIED
- Report ID
- AX-2025-020634
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2510-C7247
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 25 Nov 2025
- Submitted
- 28 Nov 2025
- Quarter
- 2025-Q4
- Submitter
- a.marchand
- Sample provenance
- Buyer-sourced
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, 30 min gradient, 214 nm | 98.26 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.74 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid mono-ester | 0.90 | % 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) | 4111.0684 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +3.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 84.68 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.21 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.35 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.955 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.06 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 10.96 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.30 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.25 | EU/mg | ≤ 5.0 | PASS |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | Off-white lyophilised cake, intact | — | white to off-white intact cake | PASS |
| 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 | 4.17 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 18.50 | min | 18.42 ± 0.45 (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 | 44,570 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.67 | — | 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 | 18.50 | 4,775,741 | 98.26 | — |
| 2 | C18 diacid mono-ester | 19.86 | 43,743 | 0.90 | +14.016 |
| 3 | [D-Aib8]-diastereomer | 18.26 | 21,385 | 0.44 | 0.000 |
| 4 | deamidated (Asn→Asp, +1 Da) | 17.99 | 8,749 | 0.18 | +0.984 |
| 5 | Met(O) sulfoxide (+16 Da) | 17.82 | 6,318 | 0.13 | +15.995 |
| 6 | des-AEEA semaglutide (−145 Da) | 17.68 | 3,402 | 0.07 | -145.074 |
| 7 | des-His1 truncate (−137 Da) | 17.36 | 972 | 0.02 | -137.059 |
| 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 3
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 | 686.1853 | 0.0026 | 8.5 |
| 5+ | 823.2178 | 823.2210 | 0.0032 | 52.5 |
| 4+ | 1028.7704 | 1028.7744 | 0.0040 | 100.0 |
| 3+ | 1371.3581 | 1371.3634 | 0.0053 | 49.7 |
| 2+ | 2056.5335 | 2056.5415 | 0.0080 | 7.6 |
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 | 4.06 |
| Counter-ion (TFA) | ion chromatography | 10.96 |
| Residual solvent + inorganic residue | estimated | 0.30 |
| Total peptide content | by difference | 84.68 |
| 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) | 98.89 | 98.26 | divergence -0.02 pp vs batch median |
| Total impurities (% area) | 1.11 | 1.74 | |
| Largest single impurity (% area) | not stated | 0.90 | |
| Water (%) | not stated | 4.06 | |
| Counter-ion (%) | not stated | 10.96 | |
| Peptide content (%w/w) | 91.7 | 84.68 | |
| Endotoxin (EU/mg) | 0.22 | 0.25 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → third-party forwarder (21 d) → laboratory (courier, cold pack, 11 d) → assay.
- Assay date
- 25 Nov 2025
- Submitted to the index
- 28 Nov 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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 SSA-2510-C7247 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043147 | SSA-2510-C7247 | Medutest | 2025-Q4 | 99.42 | 3.73 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-020628 | SSA-2510-C7247 | Medutest | 2025-Q4 | 98.08 | 3.81 | 106.3 | Supplier-supplied | 2 | MARGINAL |
| AX-2025-020629 | SSA-2510-C7247 | Kestrel | 2025-Q4 | 99.71 | 4.01 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-020630 | SSA-2510-C7247 | Kestrel | 2025-Q4 | 99.04 | 3.67 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020631 | SSA-2510-C7247 | Janoshik | 2025-Q4 | 99.32 | 3.93 | 100.1 | Supplier-supplied | 2 | MARGINAL |
| AX-2025-020632 | SSA-2510-C7247 | Janoshik | 2025-Q4 | 98.77 | 3.68 | 94.8 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043148 | SSA-2510-C7247 | Medutest | 2025-Q4 | 98.08 | 3.87 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020633 | SSA-2510-C7247 | Janoshik | 2025-Q4 | 99.49 | 3.47 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-020635 | SSA-2510-C7247 | VendorInvestigate | 2025-Q4 | 98.13 | 3.64 | — | 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-2026-043144 | GHK-Cu | SSA-2604-V7620 | Janoshik | 2026-Q2 | 98.35 | 5.25 | 105.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | Semax | SSA-2604-L7628 | Kestrel | 2026-Q2 | 98.84 | 8.58 | 93.2 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043117 | Mazdutide | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.23 | 3.67 | 90.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043136 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 97.75 | 4.32 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043118 | Mazdutide | SSA-2605-G6781 | Medutest | 2026-Q2 | 98.29 | 2.65 | 88.7 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043138 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 98.00 | 4.30 | 101.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043137 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 97.41 | 4.36 | 104.5 | Laboratory-retained | 1 | FAIL |
| AX-2026-043146 | Enclomiphene citrate | SSA-2603-C6950 | Medutest | 2026-Q2 | 97.92 | 3.11 | 92.9 | Buyer-sourced | 2 | FAIL |