AX-2026-043055
Retatrutide · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2511-K4818
- Report ID
- AX-2026-043055
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2511-K4818
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 03 Feb 2026
- Submitted
- 04 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- v.yildiz
- 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 | 96.75 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 3.25 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — incomplete Fmoc removal (+222 Da) | 2.15 | % 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) | 4728.5401 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +11.2 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.39 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.45 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.47 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.031 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.47 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.00 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.14 | % | — | 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 | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.03 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 17.38 | min | 17.53 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.21 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 61,401 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.64 | — | 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 | 17.38 | 4,702,350 | 96.75 | — |
| 2 | incomplete Fmoc removal (+222 Da) | 19.39 | 104,497 | 2.15 | +222.068 |
| 3 | aspartimide (−18 Da) | 17.97 | 22,357 | 0.46 | -18.011 |
| 4 | truncated (5-39) | 15.78 | 20,899 | 0.43 | -428.201 |
| 5 | [D-Aib2]-diastereomer | 17.20 | 6,318 | 0.13 | 0.000 |
| 6 | des-Aib20 analogue | 17.01 | 1,944 | 0.04 | -85.053 |
| 7 | retatrutide dimer | 20.81 | 1,944 | 0.04 | +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 | 676.5130 | 0.0076 | 8.7 |
| 6+ | 789.0885 | 789.0973 | 0.0088 | 56.0 |
| 5+ | 946.7047 | 946.7153 | 0.0106 | 100.0 |
| 4+ | 1183.1291 | 1183.1423 | 0.0132 | 52.3 |
| 3+ | 1577.1696 | 1577.1873 | 0.0177 | 7.6 |
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 | 3.47 |
| Counter-ion (TFA) | ion chromatography | 6.00 |
| Residual solvent + inorganic residue | estimated | 0.14 |
| Total peptide content | by difference | 90.39 |
| 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) | 97.60 | 96.75 | divergence +0.41 pp vs batch median |
| Total impurities (% area) | 2.40 | 3.25 | |
| Largest single impurity (% area) | 1.35 | 2.15 | |
| Water (%) | not stated | 3.47 | |
| Counter-ion (%) | not stated | 6.00 | |
| Peptide content (%w/w) | not stated | 90.39 | |
| 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
- Domestic warehouse despatch → submitter (2–8 °C, 14 d) → laboratory (courier, cold pack, 4 d) → assay.
- Assay date
- 03 Feb 2026
- Submitted to the index
- 04 Feb 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
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 KP-2511-K4818 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043053 | KP-2511-K4818 | Janoshik | 2026-Q1 | 97.19 | 3.75 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043054 | KP-2511-K4818 | Medutest | 2026-Q1 | 97.76 | 3.94 | 93.6 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042437 | Homopeptide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043095 | KP | KP-2607-H5774 | Janoshik | 2026-Q3 | 95.81 | 5.48 | 105.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-042282 | TFC | TFC-2608-J1156 | Janoshik | 2026-Q3 | 98.54 | 4.27 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043094 | KP | KP-2607-H5774 | PeptideMeter | 2026-Q3 | 96.32 | 6.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042441 | Homopeptide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041427 | QYB | QYB-2604-B4920 | PeptideMeter | 2026-Q3 | 97.93 | 2.45 | 101.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041786 | ASY | ASY-{CAT}-2288 | VendorInvestigate | 2026-Q3 | 98.78 | 6.59 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041428 | QYB | QYB-2604-B4920 | Janoshik | 2026-Q3 | 98.35 | 3.20 | — | Laboratory-retained | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043095 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 95.81 | 5.48 | 105.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043094 | Retatrutide | KP-2607-H5774 | PeptideMeter | 2026-Q3 | 96.32 | 6.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043096 | Retatrutide | KP-2607-H5774 | VendorInvestigate | 2026-Q3 | 96.48 | 6.05 | 104.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043090 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.46 | 5.81 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043091 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.13 | 5.94 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043077 | TB-500 | KP-2605-C5214 | Janoshik | 2026-Q2 | 99.61 | 5.64 | 90.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043093 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.54 | 5.54 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043092 | Retatrutide | KP-2607-H5774 | Medutest | 2026-Q3 | 96.64 | 6.12 | — | Buyer-sourced | 1 | FAIL |