AX-2026-042840
Survodutide · 15 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2512-Y2660
- Report ID
- AX-2026-042840
- Compound
- Survodutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2512-Y2660
- Declared label claim
- 15mg
- Laboratory
- PeptideMeter
- Assay date
- 22 Jun 2026
- Submitted
- 14 Jul 2026
- Quarter
- 2026-Q2
- Submitter
- so.demir
- 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 | 97.67 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.33 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — truncated (2-39) | 0.86 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4764.5121 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4764.5116 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.1 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.80 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.75 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 17.81 | mg | 15 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 15.272 | mg | 15 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 101.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.80 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 7.96 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.44 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.69 | 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 | 3.45 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 18.85 | min | 18.90 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.26 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 75,550 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Ser2]-diastereomer | 0.86 | — | 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 | Survodutide — main peak | 18.85 | 4,747,065 | 97.67 | — |
| 2 | truncated (2-39) | 17.58 | 41,799 | 0.86 | -137.059 |
| 3 | [D-Ser2]-diastereomer | 18.61 | 40,341 | 0.83 | 0.000 |
| 4 | des-γGlu linker (−129 Da) | 17.96 | 12,637 | 0.26 | -129.043 |
| 5 | aspartimide (−18 Da) | 19.43 | 10,207 | 0.21 | -18.011 |
| 6 | C18 diacid mono-ester | 20.19 | 5,832 | 0.12 | +14.016 |
| 7 | survodutide dimer | 22.63 | 2,430 | 0.05 | +4764.512 |
| 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 4764.5121 Da, computed from C220H340N50O67. 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 (%) |
|---|---|---|---|---|
| 7+ | 681.6519 | 681.6518 | -0.0001 | 8.7 |
| 6+ | 795.0926 | 795.0925 | -0.0001 | 60.1 |
| 5+ | 953.9097 | 953.9096 | -0.0001 | 100.0 |
| 4+ | 1192.1353 | 1192.1352 | -0.0001 | 58.2 |
| 3+ | 1589.1780 | 1589.1778 | -0.0002 | 8.4 |
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 | 3.80 |
| Counter-ion (TFA) | ion chromatography | 7.96 |
| Residual solvent + inorganic residue | estimated | 0.44 |
| Total peptide content | by difference | 87.80 |
| 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) | 97.46 | 97.67 | divergence -0.20 pp vs batch median |
| Total impurities (% area) | 1.63 | 2.33 | |
| Largest single impurity (% area) | 2.54 | 0.86 | |
| Water (%) | not stated | 3.80 | |
| Counter-ion (%) | not stated | 7.96 | |
| Peptide content (%w/w) | 91.7 | 87.80 | |
| Endotoxin (EU/mg) | 0.72 | 0.69 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 21 d) → laboratory (courier, cold pack, 10 d) → assay.
- Assay date
- 22 Jun 2026
- Submitted to the index
- 14 Jul 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations 4
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Related records
Same batch — lot GGPE-2512-Y2660 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042831 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.68 | 3.56 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042832 | GGPE-2512-Y2660 | Kestrel | 2026-Q2 | 98.68 | 3.59 | 92.0 | Laboratory-retained | 3 | FAIL |
| AX-2026-042833 | GGPE-2512-Y2660 | PeptideMeter | 2026-Q2 | 97.44 | 3.46 | 93.3 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042834 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.65 | 3.87 | 88.9 | Buyer-sourced | 3 | MARGINAL |
| AX-2026-042835 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.77 | 4.16 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042836 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.60 | 2.83 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042837 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.63 | 3.04 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042838 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.69 | 3.50 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042839 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.37 | 3.92 | 95.0 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042841 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.71 | 3.99 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042842 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 97.63 | 4.13 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042843 | GGPE-2512-Y2660 | Nordanalyt | 2026-Q2 | 97.37 | 3.00 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042844 | GGPE-2512-Y2660 | Janoshik | 2026-Q2 | 98.41 | 4.02 | — | Supplier-supplied | 2 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041831 | GSP | GSP-2603-E3156 | Kestrel | 2026-Q3 | 99.91 | 5.50 | 93.2 | Buyer-sourced | 0 | PASS |
| AX-2026-042706 | ERP | ERP-2605-E9865 | PeptideMeter | 2026-Q3 | 98.38 | 5.33 | 103.5 | Buyer-sourced | 0 | PASS |
| AX-2026-041836 | GSP | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.65 | 5.34 | 90.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041837 | GSP | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.33 | 5.37 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041833 | GSP | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.08 | 4.91 | 99.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041832 | GSP | GSP-2603-E3156 | VendorInvestigate | 2026-Q3 | 98.01 | 5.14 | 99.5 | Buyer-sourced | 0 | PASS |
| AX-2026-041835 | GSP | GSP-2603-E3156 | Nordanalyt | 2026-Q3 | 98.34 | 5.74 | 89.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041834 | GSP | GSP-2603-E3156 | VendorInvestigate | 2026-Q3 | 97.92 | 5.95 | — | 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 |