AX-2025-019224
Semaglutide · 3 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2502-L6365
PASSPURITY ONLY
- Report ID
- AX-2025-019224
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- TFC — Tianjin Finder Chemical Co., Ltd.
- Batch / lot
- TFC-2502-L6365
- Declared label claim
- 3mg
- Laboratory
- Janoshik Analytical
- Assay date
- 15 Jan 2025
- Submitted
- 06 Feb 2025
- Quarter
- 2025-Q1
- Submitter
- m.laurent
- 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, 30 min gradient, 214 nm | 98.16 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.84 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid mono-ester | 1.17 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 85.23 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.66 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 3.43 | mg | 3 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.870 | mg | 3 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.25 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 11.21 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.31 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.67 | 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 | 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 | 3.91 | — | 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 | 0.88 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 71,947 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs Met(O) sulfoxide (+16 Da) | 2.40 | — | 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 | 4,770,880 | 98.16 | — |
| 2 | C18 diacid mono-ester | 19.86 | 56,866 | 1.17 | +14.016 |
| 3 | Met(O) sulfoxide (+16 Da) | 17.82 | 17,983 | 0.37 | +15.995 |
| 4 | tBu-protected residual (+56 Da) | 20.55 | 10,207 | 0.21 | +56.063 |
| 5 | des-His1 truncate (−137 Da) | 17.36 | 2,916 | 0.06 | -137.059 |
| 6 | des-AEEA semaglutide (−145 Da) | 17.68 | 972 | 0.02 | -145.074 |
| 7 | semaglutide dimer | 22.21 | 486 | 0.01 | +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.
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 | 3.25 |
| Counter-ion (TFA) | ion chromatography | 11.21 |
| Residual solvent + inorganic residue | estimated | 0.31 |
| Total peptide content | by difference | 85.23 |
| 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) | 98.60 | 98.16 | divergence +0.44 pp vs batch median |
| Total impurities (% area) | not stated | 1.84 | |
| Largest single impurity (% area) | not stated | 1.17 | |
| Water (%) | not stated | 3.25 | |
| Counter-ion (%) | not stated | 11.21 | |
| Peptide content (%w/w) | not stated | 85.23 | |
| Endotoxin (EU/mg) | not stated | 0.67 | |
| 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, 7 d) → assay. Submitter did not handle the vial.
- Assay date
- 15 Jan 2025
- Submitted to the index
- 06 Feb 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-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 TFC-2502-L6365 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019220 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.24 | 3.77 | 95.0 | Buyer-sourced | 0 | PASS |
| AX-2025-019221 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.42 | 3.55 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019222 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.29 | 3.51 | — | Supplier-supplied | 0 | PASS |
| AX-2025-019223 | TFC-2502-L6365 | PeptideMeter | 2025-Q1 | 98.32 | 3.59 | 97.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019225 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.15 | 4.23 | 102.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019226 | TFC-2502-L6365 | Kestrel | 2025-Q1 | 99.61 | 3.54 | 93.7 | Supplier-supplied | 0 | PASS |
| AX-2025-019227 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.42 | 3.94 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-019228 | TFC-2502-L6365 | VendorInvestigate | 2025-Q1 | 97.35 | 4.07 | 104.5 | Buyer-sourced | 0 | PASS |
| AX-2025-019229 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.13 | 4.02 | 100.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019230 | TFC-2502-L6365 | Janoshik | 2025-Q1 | 98.11 | 3.43 | 103.9 | Supplier-supplied | 0 | PASS |
| AX-2025-019231 | TFC-2502-L6365 | Medutest | 2025-Q1 | 98.16 | 3.66 | 104.3 | Laboratory-retained | 1 | MARGINAL |
| AX-2025-019232 | TFC-2502-L6365 | Medutest | 2025-Q1 | 97.87 | 3.36 | 104.1 | Supplier-supplied | 0 | PASS |
| AX-2025-019233 | TFC-2502-L6365 | VendorInvestigate | 2025-Q1 | 97.88 | 3.93 | — | 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-2026-041932 | Semaglutide | TFC-2604-X4301 | Janoshik | 2026-Q3 | 98.88 | 4.31 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042067 | SS-31 (Elamipretide) | TFC-2604-Y7472 | Kestrel | 2026-Q3 | 98.66 | 4.44 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042057 | Sermorelin | TFC-2605-Y6440 | Janoshik | 2026-Q3 | 98.68 | 3.94 | 98.3 | Supplier-supplied | 0 | PASS |
| AX-2026-041936 | Semaglutide | TFC-2604-X4301 | PeptideMeter | 2026-Q3 | 98.62 | 4.30 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041973 | Humanin (HNG) | TFC-2605-U5564 | Janoshik | 2026-Q3 | 99.62 | 7.03 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-041980 | Humanin (HNG) | TFC-2605-U5564 | Janoshik | 2026-Q3 | 99.90 | 7.01 | 88.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041961 | Tirzepatide | TFC-2605-G5134 | Medutest | 2026-Q3 | 98.25 | 7.11 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042068 | SS-31 (Elamipretide) | TFC-2604-Y7472 | Medutest | 2026-Q3 | 98.71 | 3.63 | 92.9 | Supplier-supplied | 2 | MARGINAL |