AX-2026-042817
Semaglutide · 2 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2604-L2151
- Report ID
- AX-2026-042817
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2604-L2151
- Declared label claim
- 2mg
- Laboratory
- PeptideMeter
- Assay date
- 01 May 2026
- Submitted
- 20 May 2026
- Quarter
- 2026-Q2
- Submitter
- c.danquah
- 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, 28 min gradient, 214 nm | 99.17 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.83 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — Met(O) sulfoxide (+16 Da) | 0.38 | % 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) | 4111.0561 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 83.64 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.95 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.28 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.891 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 94.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.00 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 11.07 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.29 | % | — | 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 | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.14 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 17.43 | min | 17.29 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.03 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 45,325 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (Asn→Asp, +1 Da) | 1.42 | — | 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 | 17.43 | 4,819,969 | 99.17 | — |
| 2 | Met(O) sulfoxide (+16 Da) | 16.80 | 18,469 | 0.38 | +15.995 |
| 3 | deamidated (Asn→Asp, +1 Da) | 16.95 | 12,637 | 0.26 | +0.984 |
| 4 | tBu-protected residual (+56 Da) | 19.34 | 4,374 | 0.09 | +56.063 |
| 5 | C18 diacid mono-ester | 18.70 | 2,916 | 0.06 | +14.016 |
| 6 | des-His1 truncate (−137 Da) | 16.37 | 1,944 | 0.04 | -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.
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 | 686.1833 | 0.0006 | 8.1 |
| 5+ | 823.2178 | 823.2185 | 0.0007 | 55.9 |
| 4+ | 1028.7704 | 1028.7713 | 0.0009 | 100.0 |
| 3+ | 1371.3581 | 1371.3593 | 0.0012 | 59.1 |
| 2+ | 2056.5335 | 2056.5353 | 0.0018 | 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 | 5.00 |
| Counter-ion (TFA) | ion chromatography | 11.07 |
| Residual solvent + inorganic residue | estimated | 0.29 |
| Total peptide content | by difference | 83.64 |
| 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) | 98.92 | 99.17 | divergence -0.08 pp vs batch median |
| Total impurities (% area) | 1.08 | 0.83 | |
| Largest single impurity (% area) | 0.44 | 0.38 | |
| Water (%) | 4.7 | 5.00 | |
| Counter-ion (%) | 8.4 | 11.07 | |
| Peptide content (%w/w) | 86.3 | 83.64 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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 (ambient, 6 d) → laboratory (hand-carried, 8 d) → assay.
- Assay date
- 01 May 2026
- Submitted to the index
- 20 May 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 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 GGPE-2604-L2151 n=4
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042814 | GGPE-2604-L2151 | Janoshik | 2026-Q2 | 99.08 | 5.39 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042815 | GGPE-2604-L2151 | Janoshik | 2026-Q2 | 98.91 | 5.49 | 99.4 | Buyer-sourced | 0 | PASS |
| AX-2026-042816 | GGPE-2604-L2151 | VendorInvestigate | 2026-Q2 | 98.38 | 5.14 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043376 | WXT | WXT-2604-C3248 | Janoshik | 2026-Q3 | 97.08 | 4.22 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042424 | Homopeptide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041643 | FGP | FGP-2602-M8547 | Janoshik | 2026-Q3 | 99.31 | 2.79 | 100.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041334 | WWB | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.93 | 4.62 | 99.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042002 | AMB | AMB-2607-N6274 | VendorInvestigate | 2026-Q3 | 98.23 | 6.37 | 97.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041337 | WWB | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 99.52 | 3.92 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042595 | HJ | HJ-2608-C7002 | Janoshik | 2026-Q3 | 99.50 | 3.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042217 | TFC | TFC-2604-X9037 | PeptideMeter | 2026-Q3 | 98.95 | 4.61 | 96.9 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042784 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Medutest | 2026-Q3 | 98.27 | 4.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042786 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 3.77 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042858 | Selank | GGPE-2603-J2447 | VendorInvestigate | 2026-Q3 | 98.87 | 8.85 | 99.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042783 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 4.45 | 90.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042757 | Melanotan II | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042785 | CJC-1295 (no DAC) | GGPE-2606-E1234 | PeptideMeter | 2026-Q3 | 97.70 | 4.64 | 91.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042756 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042755 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.25 | 6.58 | 90.4 | Buyer-sourced | 0 | PASS |