AX-2025-019813
Retatrutide · 15 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2411-D4299
- Report ID
- AX-2025-019813
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- HJ — Hubei Jianxiang Bioscience Co., Ltd.
- Batch / lot
- HJ-2411-D4299
- Declared label claim
- 15mg
- Laboratory
- Janoshik Analytical
- Assay date
- 16 Feb 2025
- Submitted
- 09 Mar 2025
- Quarter
- 2025-Q1
- Submitter
- c.sobczak
- 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, 30 min gradient, 214 nm | 99.46 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.54 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — truncated (5-39) | 0.37 | % 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 | 86.62 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.15 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 18.14 | mg | 15 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 15.628 | mg | 15 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.49 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 7.34 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.55 | % | — | 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, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.03 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 20.76 | min | 20.71 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.30 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 45,732 | — | ≥ 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 | 20.76 | 4,834,064 | 99.46 | — |
| 2 | truncated (5-39) | 18.84 | 17,983 | 0.37 | -428.201 |
| 3 | C18 diacid regioisomer | 21.34 | 4,860 | 0.10 | 0.000 |
| 4 | des-Aib20 analogue | 20.32 | 1,944 | 0.04 | -85.053 |
| 5 | [D-Aib2]-diastereomer | 20.54 | 1,458 | 0.03 | 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 | 5.49 |
| Counter-ion (TFA) | ion chromatography | 7.34 |
| Residual solvent + inorganic residue | estimated | 0.55 |
| Total peptide content | by difference | 86.62 |
| 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) | 99.05 | 99.46 | divergence 0.00 pp vs batch median |
| Total impurities (% area) | 0.95 | 0.54 | |
| Largest single impurity (% area) | 0.68 | 0.37 | |
| Water (%) | 4.2 | 5.49 | |
| Counter-ion (%) | not stated | 7.34 | |
| Peptide content (%w/w) | 91.0 | 86.62 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 16 Feb 2025
- Submitted to the index
- 09 Mar 2025
- 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 HJ-2411-D4299 n=8
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019814 | HJ-2411-D4299 | Kestrel | 2025-Q1 | 98.99 | 5.53 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019815 | HJ-2411-D4299 | Medutest | 2025-Q1 | 99.84 | 5.20 | 107.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019816 | HJ-2411-D4299 | PeptideMeter | 2025-Q1 | 98.52 | 5.67 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2025-019817 | HJ-2411-D4299 | Medutest | 2025-Q1 | 98.97 | 5.52 | 107.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019818 | HJ-2411-D4299 | Medutest | 2025-Q1 | 98.88 | 5.74 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-019819 | HJ-2411-D4299 | Janoshik | 2025-Q1 | 99.17 | 5.65 | 105.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-019820 | HJ-2411-D4299 | Janoshik | 2025-Q1 | 99.11 | 4.94 | — | 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-2026-042368 | Semax | HJ-2603-V4363 | Nordanalyt | 2026-Q3 | 99.17 | 7.26 | 106.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042347 | Semaglutide | HJ-2608-C3931 | VendorInvestigate | 2026-Q3 | 98.80 | 3.41 | 100.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042367 | Semax | HJ-2603-V4363 | Kestrel | 2026-Q3 | 99.10 | 6.78 | 93.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042348 | Semaglutide | HJ-2608-C3931 | Nordanalyt | 2026-Q3 | 99.52 | 4.19 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042290 | GHRP-6 | HJ-2603-R2258 | Janoshik | 2026-Q3 | 99.71 | 3.05 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042287 | GHRP-6 | HJ-2603-R2258 | VendorInvestigate | 2026-Q3 | 98.79 | 2.43 | 90.9 | Buyer-sourced | 2 | FAIL |
| AX-2026-042288 | GHRP-6 | HJ-2603-R2258 | Kestrel | 2026-Q3 | 99.93 | 2.82 | 92.8 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042346 | Semaglutide | HJ-2608-C3931 | VendorInvestigate | 2026-Q3 | 99.40 | 3.48 | — | Buyer-sourced | 1 | MARGINAL |