AX-2024-004460
Retatrutide · 20 mg declared · SinoPep Biotechnology (Changzhou) Co., Ltd. · lot SNP-2405-T4694
- Report ID
- AX-2024-004460
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SinoPep — SinoPep Biotechnology (Changzhou) Co., Ltd.
- Batch / lot
- SNP-2405-T4694
- Declared label claim
- 20mg
- Laboratory
- Medutest
- Assay date
- 06 Nov 2024
- Submitted
- 23 Nov 2024
- Quarter
- 2024-Q4
- Submitter
- hplc_ola
- 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 | 98.06 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.94 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — incomplete Fmoc removal (+222 Da) | 0.91 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 4728.5145 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.72 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.02 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 24.82 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 21.350 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 106.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.26 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 7.29 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.73 | % | — | 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 | 3.27 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 17.46 | min | 17.53 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.31 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 73,847 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.70 | — | 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 | 17.46 | 4,766,020 | 98.06 | — |
| 2 | incomplete Fmoc removal (+222 Da) | 19.47 | 44,229 | 0.91 | +222.068 |
| 3 | [D-Aib2]-diastereomer | 17.28 | 32,564 | 0.67 | 0.000 |
| 4 | des-Aib20 analogue | 17.09 | 8,749 | 0.18 | -85.053 |
| 5 | oxidised Trp (+16 Da) | 16.91 | 3,402 | 0.07 | +15.995 |
| 6 | truncated (5-39) | 15.86 | 3,402 | 0.07 | -428.201 |
| 7 | retatrutide dimer | 20.89 | 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 | 676.5093 | 0.0039 | 8.1 |
| 6+ | 789.0885 | 789.0930 | 0.0045 | 56.4 |
| 5+ | 946.7047 | 946.7102 | 0.0055 | 100.0 |
| 4+ | 1183.1291 | 1183.1359 | 0.0068 | 49.6 |
| 3+ | 1577.1696 | 1577.1788 | 0.0092 | 8.8 |
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 | 4.26 |
| Counter-ion (TFA) | ion chromatography | 7.29 |
| Residual solvent + inorganic residue | estimated | 0.73 |
| Total peptide content | by difference | 87.72 |
| 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) | 97.48 | 98.06 | divergence -0.67 pp vs batch median |
| Total impurities (% area) | 2.52 | 1.94 | |
| Largest single impurity (% area) | not stated | 0.91 | |
| Water (%) | 2.8 | 4.26 | |
| Counter-ion (%) | not stated | 7.29 | |
| Peptide content (%w/w) | 92.4 | 87.72 | |
| 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, 26 d) → laboratory (courier, cold pack, 5 d) → assay.
- Assay date
- 06 Nov 2024
- Submitted to the index
- 23 Nov 2024
- 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 SNP-2405-T4694 n=5
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004461 | SNP-2405-T4694 | PeptideMeter | 2024-Q4 | 98.15 | 3.72 | 100.6 | Supplier-supplied | 0 | PASS |
| AX-2025-019218 | SNP-2405-T4694 | Kestrel | 2024-Q4 | 98.86 | 4.07 | 102.8 | Supplier-supplied | 0 | PASS |
| AX-2024-004462 | SNP-2405-T4694 | Janoshik | 2024-Q4 | 98.33 | 4.34 | 104.4 | Buyer-sourced | 0 | PASS |
| AX-2024-004463 | SNP-2405-T4694 | Janoshik | 2024-Q4 | 97.87 | 3.83 | — | 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-2026-041867 | CJC-1295 with DAC | SNP-2607-C3886 | Janoshik | 2026-Q3 | 99.24 | 5.12 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-041913 | Ipamorelin | SNP-2606-L4478 | PeptideMeter | 2026-Q3 | 98.88 | 5.28 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-041914 | Ipamorelin | SNP-2606-L4478 | Janoshik | 2026-Q3 | 99.14 | 5.49 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041909 | Ipamorelin | SNP-2606-L4478 | PeptideMeter | 2026-Q3 | 99.00 | 5.48 | 89.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041895 | Ipamorelin | SNP-2602-B3833 | Janoshik | 2026-Q3 | 99.93 | 4.72 | 105.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041930 | IGF-1 LR3 | SNP-2606-D4620 | Medutest | 2026-Q3 | 98.54 | 5.37 | 93.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041898 | Ipamorelin | SNP-2602-B3833 | Nordanalyt | 2026-Q3 | 99.93 | 4.54 | 96.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041931 | IGF-1 LR3 | SNP-2606-D4620 | PeptideMeter | 2026-Q3 | 97.93 | 5.19 | 93.4 | Buyer-sourced | 0 | PASS |