AX-2024-005012
Semaglutide · 5 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2405-P2227
MARGINALPURITY ONLY
- Report ID
- AX-2024-005012
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2405-P2227
- Declared label claim
- 5mg
- Laboratory
- Janoshik Analytical
- Assay date
- 19 Jul 2024
- Submitted
- 26 Jul 2024
- Quarter
- 2024-Q3
- Submitter
- r.kirchner
- 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 | 98.14 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.86 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid mono-ester | 1.25 | % 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 | 85.98 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.38 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 6.14 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.181 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 103.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.92 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.33 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.77 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 2.18 | 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 cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| 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 | 2.91 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 18.43 | min | 18.42 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.00 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 64,376 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.81 | — | 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 | 18.43 | 4,769,908 | 98.14 | — |
| 2 | C18 diacid mono-ester | 19.79 | 60,754 | 1.25 | +14.016 |
| 3 | tBu-protected residual (+56 Da) | 20.48 | 19,441 | 0.40 | +56.063 |
| 4 | deamidated (Asn→Asp, +1 Da) | 17.92 | 4,860 | 0.10 | +0.984 |
| 5 | des-His1 truncate (−137 Da) | 17.29 | 2,430 | 0.05 | -137.059 |
| 6 | [D-Aib8]-diastereomer | 18.19 | 1,458 | 0.03 | 0.000 |
| 7 | des-AEEA semaglutide (−145 Da) | 17.61 | 1,458 | 0.03 | -145.074 |
| 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 | 3.92 |
| Counter-ion (TFA) | ion chromatography | 9.33 |
| Residual solvent + inorganic residue | estimated | 0.77 |
| Total peptide content | by difference | 85.98 |
| 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) | 98.30 | 98.14 | divergence +0.25 pp vs batch median |
| Total impurities (% area) | 1.70 | 1.86 | |
| Largest single impurity (% area) | not stated | 1.25 | |
| Water (%) | not stated | 3.92 | |
| Counter-ion (%) | 9.2 | 9.33 | |
| Peptide content (%w/w) | 86.7 | 85.98 | |
| Endotoxin (EU/mg) | 1.27 | 2.18 | |
| 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, 11 d) → assay. Submitter did not handle the vial.
- Assay date
- 19 Jul 2024
- Submitted to the index
- 26 Jul 2024
- 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 GGPE-2405-P2227 n=17
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005010 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.05 | 4.06 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005011 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.79 | 3.97 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005013 | GGPE-2405-P2227 | VendorInvestigate | 2024-Q3 | 97.94 | 3.59 | 107.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-005014 | GGPE-2405-P2227 | Nordanalyt | 2024-Q3 | 98.26 | 4.22 | 99.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005015 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.04 | 3.00 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005016 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 97.51 | 4.24 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2024-005017 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.87 | 3.66 | 103.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005018 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.00 | 2.91 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005019 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.02 | 4.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005020 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 97.97 | 3.66 | 102.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005021 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.78 | 3.57 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005022 | GGPE-2405-P2227 | Medutest | 2024-Q3 | 97.72 | 3.83 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005023 | GGPE-2405-P2227 | Medutest | 2024-Q3 | 98.28 | 3.37 | 97.2 | Supplier-supplied | 2 | FAIL |
| AX-2024-005024 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 98.43 | 3.73 | 104.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005025 | GGPE-2405-P2227 | Medutest | 2024-Q3 | 98.18 | 4.00 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2024-005026 | GGPE-2405-P2227 | Janoshik | 2024-Q3 | 97.81 | 3.49 | — | 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-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |