AX-2026-043118
Mazdutide · 9 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2605-G6892
- 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-G6892
- Declared label claim
- 9mg
- Laboratory
- PeptideMeter
- Assay date
- 25 May 2026
- Submitted
- 03 Jun 2026
- Quarter
- 2026-Q2
- Submitter
- n.girard
- 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 | 98.96 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.04 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — trifluoroacetyl adduct (+96 Da) | 0.58 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4912.6408 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4912.6364 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.47 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.54 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.03 | mg | 9 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 8.881 | mg | 9 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 98.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.25 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.83 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.45 | % | — | 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 | 4.12 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 18.37 | min | 18.23 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.05 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 71,694 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.70 | — | 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 | 18.37 | 4,809,763 | 98.96 | — |
| 2 | trifluoroacetyl adduct (+96 Da) | 19.21 | 28,190 | 0.58 | +95.982 |
| 3 | [D-Aib2]-diastereomer | 18.17 | 12,151 | 0.25 | 0.000 |
| 4 | oxidised Met (+16 Da) | 17.72 | 6,804 | 0.14 | +15.995 |
| 5 | truncated (4-39) | 16.75 | 1,944 | 0.04 | -315.169 |
| 6 | des-Aib2 analogue | 18.01 | 1,458 | 0.03 | -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.
Mass spectrum and identity
Theoretical monoisotopic mass 4912.6408 Da, computed from C226H352N50O70. 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+ | 702.8131 | 702.8125 | -0.0006 | 7.9 |
| 6+ | 819.7807 | 819.7800 | -0.0007 | 54.1 |
| 5+ | 983.5354 | 983.5346 | -0.0008 | 100.0 |
| 4+ | 1229.1675 | 1229.1664 | -0.0011 | 56.7 |
| 3+ | 1638.5542 | 1638.5527 | -0.0015 | 8.7 |
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 | 3.25 |
| Counter-ion (TFA) | ion chromatography | 6.83 |
| Residual solvent + inorganic residue | estimated | 0.45 |
| Total peptide content | by difference | 89.47 |
| 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) | 98.87 | 98.96 | divergence -0.05 pp vs batch median |
| Total impurities (% area) | 1.13 | 1.04 | |
| Largest single impurity (% area) | 0.66 | 0.58 | |
| Water (%) | 1.5 | 3.25 | |
| Counter-ion (%) | not stated | 6.83 | |
| Peptide content (%w/w) | not stated | 89.47 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| 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 (−20 °C, 26 d) → laboratory (courier, dry ice, 12 d) → assay.
- Assay date
- 25 May 2026
- Submitted to the index
- 03 Jun 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations 1
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 SSA-2605-G6892 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043117 | SSA-2605-G6892 | Janoshik | 2026-Q2 | 98.87 | 3.02 | 99.6 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042930 | MKM | MKM-2511-N3837 | Janoshik | 2026-Q2 | 98.08 | 7.96 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042923 | MKM | MKM-2511-N3837 | Janoshik | 2026-Q2 | 98.46 | 6.72 | 97.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042928 | MKM | MKM-2511-N3837 | Janoshik | 2026-Q2 | 98.59 | 6.41 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042926 | MKM | MKM-2511-N3837 | Nordanalyt | 2026-Q2 | 98.67 | 6.63 | 93.6 | Buyer-sourced | 0 | PASS |
| AX-2026-041921 | SinoPep | SNP-2602-U4281 | Janoshik | 2026-Q2 | 98.21 | 4.18 | 92.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041920 | SinoPep | SNP-2602-U4281 | Janoshik | 2026-Q2 | 97.77 | 4.41 | 88.7 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042924 | MKM | MKM-2511-N3837 | Nordanalyt | 2026-Q2 | 98.78 | 7.43 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041919 | SinoPep | SNP-2602-U4281 | Nordanalyt | 2026-Q2 | 98.01 | 4.37 | 93.8 | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043135 | BPC-157 | SSA-2601-N6863 | Nordanalyt | 2026-Q2 | 98.16 | 4.66 | 92.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043160 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.01 | 4.02 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043157 | GHK-Cu | SSA-2604-V7731 | Medutest | 2026-Q2 | 99.19 | 5.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | BPC-157 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.06 | 4.06 | 94.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043154 | GHK-Cu | SSA-2604-V7731 | PeptideMeter | 2026-Q2 | 97.82 | 4.82 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043137 | BPC-157 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 98.17 | 4.14 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043162 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.50 | 4.36 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043134 | BPC-157 | SSA-2601-N6863 | Medutest | 2026-Q2 | 97.89 | 4.01 | — | Buyer-sourced | 1 | FAIL |