Two instruments or it is not confirmed, and this record is one instrument. It is a good one instrument, and the index records it as confirmed rather than corroborated for that reason.
AX-2024-004756
Survodutide · 5 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2406-F5091
PASSIDENTITY CONSISTENT
- Report ID
- AX-2024-004756
- Compound
- Survodutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- Homopeptide — Hunan Aslsen Technology Co., Ltd.
- Batch / lot
- HOMO-2406-F5091
- Declared label claim
- 5mg
- Laboratory
- Janoshik Analytical
- Assay date
- 07 Dec 2024
- Submitted
- 23 Dec 2024
- Quarter
- 2024-Q4
- Submitter
- s.wikstrom
- 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 | 99.24 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.76 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — [D-Ser2]-diastereomer | 0.52 | % 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) | 4764.5145 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.5 | ppm | ± 15 | PASS |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 5.12 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.80 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.47 | % | — | 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 | Off-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 | 4.31 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 20.09 | min | 20.14 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.13 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 81,572 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Ser2]-diastereomer | 0.90 | — | 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 | Survodutide — main peak | 20.09 | 4,823,372 | 99.24 | — |
| 2 | [D-Ser2]-diastereomer | 19.83 | 25,274 | 0.52 | 0.000 |
| 3 | des-γGlu linker (−129 Da) | 19.14 | 6,804 | 0.14 | -129.043 |
| 4 | C18 diacid mono-ester | 21.53 | 2,430 | 0.05 | +14.016 |
| 5 | survodutide dimer | 24.14 | 1,458 | 0.03 | +4764.512 |
| 6 | truncated (2-39) | 18.73 | 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 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 | 681.6522 | 0.0003 | 8.1 |
| 6+ | 795.0926 | 795.0930 | 0.0004 | 55.7 |
| 5+ | 953.9097 | 953.9102 | 0.0005 | 100.0 |
| 4+ | 1192.1353 | 1192.1359 | 0.0006 | 53.0 |
| 3+ | 1589.1780 | 1589.1788 | 0.0008 | 7.8 |
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.
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) | 99.52 | 99.24 | divergence +0.17 pp vs batch median |
| Total impurities (% area) | not stated | 0.76 | |
| Largest single impurity (% area) | not stated | 0.52 | |
| Water (%) | 2.8 | 5.12 | |
| Counter-ion (%) | not stated | 6.80 | |
| Peptide content (%w/w) | 92.4 | not determined | |
| Endotoxin (EU/mg) | not stated | not determined | |
| 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 → submitter (ambient, 25 d) → laboratory (hand-carried, 7 d) → assay.
- Assay date
- 07 Dec 2024
- Submitted to the index
- 23 Dec 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- IDENTITY CONSISTENT
Section 6
Annotations 2
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.
Anyone can generate one of these. That is the argument the index makes on its submission page and it is the reason the dataset grows without any supplier's cooperation.
Section 7
Related records
Same batch — lot HOMO-2406-F5091 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004757 | HOMO-2406-F5091 | Janoshik | 2024-Q4 | 99.42 | 5.35 | 95.9 | Buyer-sourced | 0 | PASS |
| AX-2024-004758 | HOMO-2406-F5091 | Janoshik | 2024-Q4 | 99.39 | 4.83 | 98.4 | Buyer-sourced | 0 | PASS |
| AX-2024-004759 | HOMO-2406-F5091 | PeptideMeter | 2024-Q4 | 99.93 | 4.15 | 98.1 | Supplier-supplied | 0 | PASS |
| AX-2024-004760 | HOMO-2406-F5091 | PeptideMeter | 2024-Q4 | 99.09 | 4.41 | 100.4 | Buyer-sourced | 0 | PASS |
| AX-2024-004761 | HOMO-2406-F5091 | VendorInvestigate | 2024-Q4 | 99.19 | 4.48 | 91.3 | Buyer-sourced | 0 | PASS |
| AX-2024-004762 | HOMO-2406-F5091 | Medutest | 2024-Q4 | 99.44 | 5.10 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019832 | HOMO-2406-F5091 | Nordanalyt | 2024-Q4 | 99.14 | 4.78 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019833 | HOMO-2406-F5091 | PeptideMeter | 2024-Q4 | 99.32 | 5.17 | 99.3 | Buyer-sourced | 0 | PASS |
| AX-2024-004763 | HOMO-2406-F5091 | PeptideMeter | 2024-Q4 | 99.01 | 4.84 | 93.6 | Buyer-sourced | 0 | PASS |
| AX-2025-019834 | HOMO-2406-F5091 | Janoshik | 2024-Q4 | 99.70 | 4.86 | 96.5 | Buyer-sourced | 0 | PASS |
| AX-2024-004764 | HOMO-2406-F5091 | Janoshik | 2024-Q4 | 99.74 | 4.81 | 92.8 | Buyer-sourced | 0 | PASS |
| AX-2024-004765 | HOMO-2406-F5091 | Nordanalyt | 2024-Q4 | 99.47 | 4.88 | 95.2 | Buyer-sourced | 0 | PASS |
| AX-2024-004766 | HOMO-2406-F5091 | Medutest | 2024-Q4 | 99.17 | 4.78 | — | Buyer-sourced | 0 | PASS |
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-2026-042437 | Retatrutide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042424 | Semaglutide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042503 | IGF-1 LR3 | HOMO-2607-P5131 | Janoshik | 2026-Q3 | 99.36 | 5.99 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042492 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Medutest | 2026-Q3 | 99.93 | 2.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042491 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 3.24 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042473 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.01 | 5.00 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042441 | Retatrutide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042474 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.18 | 5.44 | — | Buyer-sourced | 0 | PASS |