AX-2026-041838
Retatrutide · 20 mg declared · Guangzhou JEEP Biotechnology Co., Ltd. · lot JEEP-2510-W2963
- Report ID
- AX-2026-041838
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- JEEP — Guangzhou JEEP Biotechnology Co., Ltd.
- Batch / lot
- JEEP-2510-W2963
- Declared label claim
- 20mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 26 Dec 2025
- Submitted
- 18 Jan 2026
- Quarter
- 2025-Q4
- Submitter
- b.bhattacharya
- Sample provenance
- Laboratory-retained
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, 15 min gradient, 214 nm | 99.28 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.72 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 0.45 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 4728.4644 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -4.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.60 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.98 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 23.66 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 20.106 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.54 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 7.38 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.48 | % | — | 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 with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.31 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 11.13 | min | 11.18 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.33 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 50,356 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.54 | — | 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 | 11.13 | 4,825,316 | 99.28 | — |
| 2 | oxidised Trp (+16 Da) | 10.80 | 21,871 | 0.45 | +15.995 |
| 3 | des-Aib20 analogue | 10.91 | 8,749 | 0.18 | -85.053 |
| 4 | [D-Aib2]-diastereomer | 11.02 | 2,916 | 0.06 | 0.000 |
| 5 | incomplete Fmoc removal (+222 Da) | 12.34 | 972 | 0.02 | +222.068 |
| 6 | aspartimide (−18 Da) | 11.49 | 486 | 0.01 | -18.011 |
| 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 4728.4871 Da, computed from C221H342N46O68. 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+ | 676.5054 | 676.5022 | -0.0032 | 8.4 |
| 6+ | 789.0885 | 789.0847 | -0.0038 | 50.0 |
| 5+ | 946.7047 | 946.7002 | -0.0045 | 100.0 |
| 4+ | 1183.1291 | 1183.1234 | -0.0057 | 52.1 |
| 3+ | 1577.1696 | 1577.1621 | -0.0075 | 8.3 |
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 | 6.54 |
| Counter-ion (TFA) | ion chromatography | 7.38 |
| Residual solvent + inorganic residue | estimated | 0.48 |
| Total peptide content | by difference | 85.60 |
| 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) | 99.03 | 99.28 | divergence -0.04 pp vs batch median |
| Total impurities (% area) | 0.97 | 0.72 | |
| Largest single impurity (% area) | not stated | 0.45 | |
| Water (%) | 5.2 | 6.54 | |
| Counter-ion (%) | not stated | 7.38 | |
| Peptide content (%w/w) | not stated | 85.60 | |
| 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
- Laboratory-retained
- Evidentiary weight
- Provenance documented, selection uncontrolled.
- Chain of custody
- Laboratory retained sample (−20 °C, 25 d since original receipt) → re-assay.
- Assay date
- 26 Dec 2025
- Submitted to the index
- 18 Jan 2026
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- METHOD LIMITED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot JEEP-2510-W2963 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019029 | JEEP-2510-W2963 | Janoshik | 2025-Q4 | 98.64 | 6.02 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019030 | JEEP-2510-W2963 | Janoshik | 2025-Q4 | 99.07 | 6.25 | 89.7 | 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-2026-041847 | TB-500 | JEEP-2602-V3434 | Nordanalyt | 2026-Q3 | 99.72 | 3.85 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041886 | Semaglutide | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.19 | 4.03 | 96.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041882 | Semaglutide | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.17 | 4.52 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041845 | TB-500 | JEEP-2602-V3434 | Janoshik | 2026-Q3 | 99.72 | 4.04 | 102.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041921 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.90 | 1.76 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041922 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.41 | 2.60 | 95.7 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041928 | TB-500 | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.88 | 1.84 | 92.8 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041849 | TB-500 | JEEP-2602-V3434 | VendorInvestigate | 2026-Q3 | 99.73 | 3.60 | 88.6 | Buyer-sourced | 2 | MARGINAL |