AX-2024-004748
Retatrutide · 20 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2406-T4667
PASSVERIFIED
- Report ID
- AX-2024-004748
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- Homopeptide — Hunan Aslsen Technology Co., Ltd.
- Batch / lot
- HOMO-2406-T4667
- Declared label claim
- 20mg
- Laboratory
- Janoshik Analytical
- Assay date
- 23 Aug 2024
- Submitted
- 27 Aug 2024
- Quarter
- 2024-Q3
- Submitter
- j.ekstrom
- Sample provenance
- Buyer-sourced
Section 1
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 | 98.18 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.82 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — [D-Aib2]-diastereomer | 0.88 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4728.4729 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -3.0 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.34 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.75 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 23.19 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 19.885 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.74 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 5.94 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.98 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.35 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| 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 | 3.95 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 20.86 | min | 20.71 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.24 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 37,227 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.50 | — | no index criterion | REPORTED |
Section 2
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 | 20.86 | 4,771,852 | 98.18 | — |
| 2 | [D-Aib2]-diastereomer | 20.64 | 42,771 | 0.88 | 0.000 |
| 3 | aspartimide (−18 Da) | 21.57 | 19,441 | 0.40 | -18.011 |
| 4 | des-Aib20 analogue | 20.42 | 12,151 | 0.25 | -85.053 |
| 5 | truncated (5-39) | 18.94 | 8,749 | 0.18 | -428.201 |
| 6 | oxidised Trp (+16 Da) | 20.20 | 2,916 | 0.06 | +15.995 |
| 7 | C18 diacid regioisomer | 21.44 | 2,430 | 0.05 | 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.
Section 3
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 | 676.5034 | -0.0020 | 9.5 |
| 6+ | 789.0885 | 789.0861 | -0.0024 | 56.5 |
| 5+ | 946.7047 | 946.7019 | -0.0028 | 100.0 |
| 4+ | 1183.1291 | 1183.1255 | -0.0036 | 55.5 |
| 3+ | 1577.1696 | 1577.1649 | -0.0047 | 8.2 |
Section 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 | 5.74 |
| Counter-ion (TFA) | ion chromatography | 5.94 |
| Residual solvent + inorganic residue | estimated | 0.98 |
| Total peptide content | by difference | 87.34 |
| 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) | 98.05 | 98.18 | divergence -0.13 pp vs batch median |
| Total impurities (% area) | not stated | 1.82 | |
| Largest single impurity (% area) | not stated | 0.88 | |
| Water (%) | not stated | 5.74 | |
| Counter-ion (%) | not stated | 5.94 | |
| Peptide content (%w/w) | not stated | 87.34 | |
| Endotoxin (EU/mg) | 0.36 | 0.35 | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
Section 5
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 → submitter (2–8 °C, 28 d) → laboratory (courier, ambient, 9 d) → assay.
- Assay date
- 23 Aug 2024
- Submitted to the index
- 27 Aug 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot HOMO-2406-T4667 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004749 | HOMO-2406-T4667 | Janoshik | 2024-Q3 | 97.85 | 5.95 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004750 | HOMO-2406-T4667 | Janoshik | 2024-Q3 | 98.54 | 6.81 | — | 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-2026-042437 | Retatrutide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042424 | Semaglutide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042503 | IGF-1 LR3 | HOMO-2607-P5131 | Janoshik | 2026-Q3 | 99.36 | 5.99 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042492 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Medutest | 2026-Q3 | 99.93 | 2.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042491 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 3.24 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042473 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.01 | 5.00 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042441 | Retatrutide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042474 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.18 | 5.44 | — | Buyer-sourced | 0 | PASS |