AX-2026-042042
Retatrutide · 20 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2509-W6465
- Report ID
- AX-2026-042042
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
- Batch / lot
- HYB-2509-W6465
- Declared label claim
- 20mg
- Laboratory
- Janoshik Analytical
- Assay date
- 07 Mar 2026
- Submitted
- 01 Apr 2026
- Quarter
- 2026-Q1
- Submitter
- m.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, 30 min gradient, 214 nm | 98.22 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.78 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — truncated (5-39) | 0.94 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 85.75 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.22 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 23.86 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 20.095 | 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 | 4.19 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.69 | % | ≤ 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, partially collapsed | — | white to off-white intact cake | FAIL |
| 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 | 3.68 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 20.93 | min | 20.71 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.11 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 45,314 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.55 | — | 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 | 20.93 | 4,773,796 | 98.22 | — |
| 2 | truncated (5-39) | 19.01 | 45,687 | 0.94 | -428.201 |
| 3 | oxidised Trp (+16 Da) | 20.27 | 27,704 | 0.57 | +15.995 |
| 4 | aspartimide (−18 Da) | 21.64 | 5,832 | 0.12 | -18.011 |
| 5 | incomplete Fmoc removal (+222 Da) | 23.34 | 4,374 | 0.09 | +222.068 |
| 6 | des-Aib20 analogue | 20.49 | 1,944 | 0.04 | -85.053 |
| 7 | [D-Aib2]-diastereomer | 20.71 | 972 | 0.02 | 0.000 |
| 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 | 4.19 |
| Counter-ion (TFA) | ion chromatography | 9.69 |
| Residual solvent + inorganic residue | estimated | 0.37 |
| Total peptide content | by difference | 85.75 |
| 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) | 98.25 | 98.22 | divergence +0.02 pp vs batch median |
| Total impurities (% area) | 1.75 | 1.78 | |
| Largest single impurity (% area) | not stated | 0.94 | |
| Water (%) | 1.6 | 4.19 | |
| Counter-ion (%) | not stated | 9.69 | |
| Peptide content (%w/w) | not stated | 85.75 | |
| 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
- Retail purchase → third-party forwarder (7 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 07 Mar 2026
- Submitted to the index
- 01 Apr 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-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 HYB-2509-W6465 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042043 | HYB-2509-W6465 | Janoshik | 2026-Q1 | 98.23 | 3.54 | 104.3 | Laboratory-retained | 0 | PASS |
| AX-2026-042044 | HYB-2509-W6465 | Medutest | 2026-Q1 | 97.95 | 4.25 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042045 | HYB-2509-W6465 | Janoshik | 2026-Q1 | 98.04 | 4.18 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042046 | HYB-2509-W6465 | Medutest | 2026-Q1 | 99.58 | 4.09 | 94.7 | Buyer-sourced | 0 | PASS |
| AX-2026-042047 | HYB-2509-W6465 | Janoshik | 2026-Q1 | 98.85 | 3.58 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042048 | HYB-2509-W6465 | Janoshik | 2026-Q1 | 98.56 | 4.07 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042049 | HYB-2509-W6465 | Nordanalyt | 2026-Q1 | 98.29 | 4.09 | 103.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042050 | HYB-2509-W6465 | Janoshik | 2026-Q1 | 98.08 | 4.29 | 100.1 | Buyer-sourced | 2 | FAIL |
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-2026-042083 | MOTS-c | HYB-2606-D7858 | Medutest | 2026-Q3 | 99.93 | 2.02 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042090 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.57 | 2.36 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042084 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.28 | 2.79 | 107.3 | Buyer-sourced | 0 | PASS |
| AX-2026-042087 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.54 | 3.05 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042085 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.51 | 2.31 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042088 | MOTS-c | HYB-2606-D7858 | PeptideMeter | 2026-Q3 | 99.22 | 2.21 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042086 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.93 | 3.02 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042091 | CJC-1295 with DAC | HYB-2608-E7391 | Janoshik | 2026-Q3 | 99.38 | 5.53 | — | Buyer-sourced | 0 | PASS |