AX-2026-043118
Mazdutide · 9 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2605-G6781
- Report ID
- AX-2026-043118
- Compound
- Mazdutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2605-G6781
- Declared label claim
- 9mg
- Laboratory
- Medutest
- Assay date
- 23 Jun 2026
- Submitted
- 02 Jul 2026
- Quarter
- 2026-Q2
- Submitter
- m.cabrera
- 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, 25 min gradient, 214 nm | 98.29 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.71 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — trifluoroacetyl adduct (+96 Da) | 0.96 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 87.42 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.93 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 9.29 | mg | 9 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 7.983 | mg | 9 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 88.7 | % | 90.0 – 110.0 | FAIL |
| Water content | Karl Fischer, coulometric, duplicate | 2.65 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.67 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.26 | % | — | 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 | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.64 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 16.55 | min | 16.44 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.49 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 33,797 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.47 | — | 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 | Mazdutide — main peak | 16.55 | 4,777,199 | 98.29 | — |
| 2 | trifluoroacetyl adduct (+96 Da) | 17.30 | 46,659 | 0.96 | +95.982 |
| 3 | [D-Aib2]-diastereomer | 16.38 | 19,927 | 0.41 | 0.000 |
| 4 | oxidised Met (+16 Da) | 15.97 | 11,179 | 0.23 | +15.995 |
| 5 | truncated (4-39) | 15.10 | 2,916 | 0.06 | -315.169 |
| 6 | des-Aib2 analogue | 16.23 | 2,430 | 0.05 | -85.053 |
| 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.
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 | 2.65 |
| Counter-ion (TFA) | ion chromatography | 9.67 |
| Residual solvent + inorganic residue | estimated | 0.26 |
| Total peptide content | by difference | 87.42 |
| 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) | 99.41 | 98.29 | divergence +0.67 pp vs batch median |
| Total impurities (% area) | 0.59 | 1.71 | |
| Largest single impurity (% area) | not stated | 0.96 | |
| Water (%) | 2.2 | 2.65 | |
| Counter-ion (%) | not stated | 9.67 | |
| Peptide content (%w/w) | not stated | 87.42 | |
| 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 → third-party forwarder (15 d) → laboratory (courier, cold pack, 10 d) → assay.
- Assay date
- 23 Jun 2026
- Submitted to the index
- 02 Jul 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot SSA-2605-G6781 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043113 | SSA-2605-G6781 | Janoshik | 2026-Q2 | 98.49 | 2.68 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043114 | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.02 | 3.41 | 101.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043115 | SSA-2605-G6781 | PeptideMeter | 2026-Q2 | 98.45 | 2.48 | 97.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043116 | SSA-2605-G6781 | Janoshik | 2026-Q2 | 98.65 | 2.63 | 104.6 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-043117 | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.23 | 3.67 | 90.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043119 | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.28 | 2.75 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043120 | SSA-2605-G6781 | PeptideMeter | 2026-Q2 | 98.74 | 3.24 | 104.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043121 | SSA-2605-G6781 | Medutest | 2026-Q2 | 98.79 | 2.52 | — | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042560 | ERP | ERP-2603-D7882 | VendorInvestigate | 2026-Q2 | 97.28 | 3.81 | 104.1 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043117 | SSA | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.23 | 3.67 | 90.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042562 | ERP | ERP-2603-D7882 | Janoshik | 2026-Q2 | 97.46 | 4.39 | 102.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042561 | ERP | ERP-2603-D7882 | PeptideMeter | 2026-Q2 | 97.94 | 4.04 | 97.5 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043115 | SSA | SSA-2605-G6781 | PeptideMeter | 2026-Q2 | 98.45 | 2.48 | 97.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043119 | SSA | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.28 | 2.75 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043120 | SSA | SSA-2605-G6781 | PeptideMeter | 2026-Q2 | 98.74 | 3.24 | 104.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043116 | SSA | SSA-2605-G6781 | Janoshik | 2026-Q2 | 98.65 | 2.63 | 104.6 | Laboratory-retained | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043144 | GHK-Cu | SSA-2604-V7620 | Janoshik | 2026-Q2 | 98.35 | 5.25 | 105.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | Semax | SSA-2604-L7628 | Kestrel | 2026-Q2 | 98.84 | 8.58 | 93.2 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043117 | Mazdutide | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.23 | 3.67 | 90.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043136 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 97.75 | 4.32 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043138 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 98.00 | 4.30 | 101.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043137 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 97.41 | 4.36 | 104.5 | Laboratory-retained | 1 | FAIL |
| AX-2026-043146 | Enclomiphene citrate | SSA-2603-C6950 | Medutest | 2026-Q2 | 97.92 | 3.11 | 92.9 | Buyer-sourced | 2 | FAIL |
| AX-2026-043142 | Semax | SSA-2604-L7628 | VendorInvestigate | 2026-Q2 | 98.30 | 8.24 | — | Buyer-sourced | 2 | FAIL |