AX-2026-042976
Retatrutide · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2511-K4263
- Report ID
- AX-2026-042976
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2511-K4263
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 11 Feb 2026
- Submitted
- 13 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- c18_2p6
- Sample provenance
- Supplier-supplied
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 | 97.25 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.75 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — incomplete Fmoc removal (+222 Da) | 1.82 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 4728.5230 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +7.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.26 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.89 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.79 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.891 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 98.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.51 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.78 | % | ≤ 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 | 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 | 4.38 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 17.66 | min | 17.53 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.17 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 36,436 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.48 | — | 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 | 17.66 | 4,726,651 | 97.25 | — |
| 2 | incomplete Fmoc removal (+222 Da) | 19.67 | 88,458 | 1.82 | +222.068 |
| 3 | aspartimide (−18 Da) | 18.25 | 18,955 | 0.39 | -18.011 |
| 4 | truncated (5-39) | 16.06 | 17,983 | 0.37 | -428.201 |
| 5 | [D-Aib2]-diastereomer | 17.48 | 5,346 | 0.11 | 0.000 |
| 6 | des-Aib20 analogue | 17.29 | 1,458 | 0.03 | -85.053 |
| 7 | retatrutide dimer | 21.09 | 1,458 | 0.03 | +4728.487 |
| 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 | 676.5106 | 0.0052 | 8.5 |
| 6+ | 789.0885 | 789.0944 | 0.0059 | 55.0 |
| 5+ | 946.7047 | 946.7119 | 0.0072 | 100.0 |
| 4+ | 1183.1291 | 1183.1380 | 0.0089 | 61.7 |
| 3+ | 1577.1696 | 1577.1816 | 0.0120 | 9.4 |
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 3.51 |
| Counter-ion (TFA) | ion chromatography | 9.78 |
| Residual solvent + inorganic residue | estimated | 0.45 |
| Total peptide content | by difference | 86.26 |
| 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) | 97.46 | 97.25 | divergence +0.34 pp vs batch median |
| Total impurities (% area) | not stated | 2.75 | |
| Largest single impurity (% area) | not stated | 1.82 | |
| Water (%) | not stated | 3.51 | |
| Counter-ion (%) | not stated | 9.78 | |
| Peptide content (%w/w) | not stated | 86.26 | |
| Endotoxin (EU/mg) | 0.35 | 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
- Assay date
- 11 Feb 2026
- Submitted to the index
- 13 Feb 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot KP-2511-K4263 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042972 | KP-2511-K4263 | Janoshik | 2026-Q1 | 96.65 | 3.75 | 107.2 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042973 | KP-2511-K4263 | Nordanalyt | 2026-Q1 | 97.08 | 3.64 | 105.1 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042974 | KP-2511-K4263 | Janoshik | 2026-Q1 | 97.05 | 3.63 | 99.2 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042975 | KP-2511-K4263 | Janoshik | 2026-Q1 | 96.71 | 3.37 | 92.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042977 | KP-2511-K4263 | Janoshik | 2026-Q1 | 97.12 | 3.55 | 106.1 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042978 | KP-2511-K4263 | Nordanalyt | 2026-Q1 | 97.67 | 3.30 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042979 | KP-2511-K4263 | Medutest | 2026-Q1 | 97.28 | 3.97 | 98.5 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042980 | KP-2511-K4263 | Janoshik | 2026-Q1 | 97.23 | 4.39 | — | 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-2026-043029 | Retatrutide | KP-2607-H5219 | Medutest | 2026-Q3 | 95.45 | 5.71 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043030 | Retatrutide | KP-2607-H5219 | Kestrel | 2026-Q3 | 95.97 | 6.95 | 97.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-043106 | Tirzepatide | KP-2608-D5921 | PeptideMeter | 2026-Q3 | 98.90 | 5.45 | 105.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043108 | Tirzepatide | KP-2608-D5921 | Janoshik | 2026-Q3 | 99.70 | 5.45 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043039 | Retatrutide | KP-2607-H5219 | Janoshik | 2026-Q3 | 96.14 | 5.62 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043100 | Tirzepatide | KP-2608-D5921 | VendorInvestigate | 2026-Q3 | 98.27 | 5.31 | 94.4 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043090 | Ipamorelin | KP-2606-D5887 | Janoshik | 2026-Q3 | 98.18 | 3.07 | 101.2 | Laboratory-retained | 1 | FAIL |
| AX-2026-043028 | Retatrutide | KP-2607-H5219 | Janoshik | 2026-Q3 | 96.52 | 6.09 | — | Supplier-supplied | 2 | MARGINAL |