AX-2026-043164
Retatrutide · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2601-T7702
- Report ID
- AX-2026-043164
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2601-T7702
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 21 Feb 2026
- Submitted
- 13 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- j.ogunleye
- 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 | 97.76 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.24 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 1.59 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 84.99 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.09 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 12.92 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.735 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 107.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.11 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 8.53 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.37 | % | — | 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 cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear after 90 s gentle swirling, no particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.36 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 17.43 | min | 17.53 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.94 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 71,587 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.69 | — | 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 | Retatrutide — main peak | 17.43 | 4,751,439 | 97.76 | — |
| 2 | oxidised Trp (+16 Da) | 16.88 | 77,279 | 1.59 | +15.995 |
| 3 | [D-Aib2]-diastereomer | 17.25 | 20,413 | 0.42 | 0.000 |
| 4 | truncated (5-39) | 15.83 | 6,318 | 0.13 | -428.201 |
| 5 | incomplete Fmoc removal (+222 Da) | 19.44 | 3,402 | 0.07 | +222.068 |
| 6 | C18 diacid regioisomer | 17.91 | 972 | 0.02 | 0.000 |
| 7 | des-Aib20 analogue | 17.06 | 486 | 0.01 | -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 | 6.11 |
| Counter-ion (TFA) | ion chromatography | 8.53 |
| Residual solvent + inorganic residue | estimated | 0.37 |
| Total peptide content | by difference | 84.99 |
| 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) | 99.20 | 97.76 | divergence +0.40 pp vs batch median |
| Total impurities (% area) | 0.80 | 2.24 | |
| Largest single impurity (% area) | 0.47 | 1.59 | |
| Water (%) | not stated | 6.11 | |
| Counter-ion (%) | 8.9 | 8.53 | |
| Peptide content (%w/w) | 87.0 | 84.99 | |
| 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, 33 d) → laboratory (courier, dry ice, 4 d) → assay.
- Assay date
- 21 Feb 2026
- Submitted to the index
- 13 Mar 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-2601-T7702 n=8
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043158 | SSA-2601-T7702 | Medutest | 2026-Q1 | 98.96 | 5.07 | 96.2 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043159 | SSA-2601-T7702 | Janoshik | 2026-Q1 | 98.75 | 5.38 | 91.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043160 | SSA-2601-T7702 | Nordanalyt | 2026-Q1 | 99.04 | 5.37 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043161 | SSA-2601-T7702 | Janoshik | 2026-Q1 | 98.69 | 4.72 | 90.9 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043162 | SSA-2601-T7702 | Medutest | 2026-Q1 | 98.70 | 5.82 | 106.4 | Supplier-supplied | 3 | FAIL |
| AX-2026-043163 | SSA-2601-T7702 | Medutest | 2026-Q1 | 98.90 | 5.14 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043165 | SSA-2601-T7702 | Medutest | 2026-Q1 | 98.85 | 4.89 | 105.4 | Supplier-supplied | 2 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043029 | KP | KP-2607-H5219 | Medutest | 2026-Q3 | 95.45 | 5.71 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043030 | KP | KP-2607-H5219 | Kestrel | 2026-Q3 | 95.97 | 6.95 | 97.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-041453 | QYB | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 98.02 | 2.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041454 | QYB | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.84 | 2.77 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041538 | QYB | QYB-2602-G6308 | Medutest | 2026-Q3 | 98.50 | 2.85 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041456 | QYB | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.23 | 3.24 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041452 | QYB | QYB-2604-B5660 | Nordanalyt | 2026-Q3 | 98.50 | 3.36 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043039 | KP | KP-2607-H5219 | Janoshik | 2026-Q3 | 96.14 | 5.62 | — | Supplier-supplied | 2 | FAIL |
| 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-2026-043118 | Mazdutide | SSA-2605-G6781 | Medutest | 2026-Q2 | 98.29 | 2.65 | 88.7 | Buyer-sourced | 2 | MARGINAL |
| 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 |