AX-2025-018624
Retatrutide · 5 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2502-D5359
- Report ID
- AX-2025-018624
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- QSC — Qingdao Sigma Chemical Co., Ltd.
- Batch / lot
- QSC-2502-D5359
- Declared label claim
- 5mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 26 Jul 2025
- Submitted
- 08 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- i.vestergaard
- 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, 15 min gradient, 214 nm | 99.03 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.97 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — truncated (5-39) | 0.46 | % 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) | 4728.4866 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.1 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.66 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 84.83 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 6.18 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.242 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.06 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.83 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.45 | % | — | 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 after 90 s gentle swirling, no particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.44 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 11.09 | min | 11.18 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.55 | — | 0.80 – 1.50 | FAIL |
| Plate count, main peak | N = 5.54 (t/w½)² | 40,499 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.49 | — | 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 | 11.09 | 4,813,165 | 99.03 | — |
| 2 | truncated (5-39) | 10.13 | 22,357 | 0.46 | -428.201 |
| 3 | des-Aib20 analogue | 10.87 | 12,637 | 0.26 | -85.053 |
| 4 | [D-Aib2]-diastereomer | 10.98 | 5,346 | 0.11 | 0.000 |
| 5 | C18 diacid regioisomer | 11.38 | 3,888 | 0.08 | 0.000 |
| 6 | oxidised Trp (+16 Da) | 10.76 | 2,916 | 0.06 | +15.995 |
| 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 | 676.5054 | -0.0000 | 8.4 |
| 6+ | 789.0885 | 789.0884 | -0.0001 | 54.8 |
| 5+ | 946.7047 | 946.7046 | -0.0001 | 100.0 |
| 4+ | 1183.1291 | 1183.1289 | -0.0002 | 53.2 |
| 3+ | 1577.1696 | 1577.1695 | -0.0001 | 8.4 |
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 | 7.06 |
| Counter-ion (TFA) | ion chromatography | 6.83 |
| Residual solvent + inorganic residue | estimated | 0.45 |
| Total peptide content | by difference | 85.66 |
| 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 | 99.03 | divergence -0.40 pp vs batch median |
| Total impurities (% area) | not stated | 0.97 | |
| Largest single impurity (% area) | not stated | 0.46 | |
| Water (%) | 6.0 | 7.06 | |
| Counter-ion (%) | not stated | 6.83 | |
| Peptide content (%w/w) | 89.2 | 85.66 | |
| 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 (21 d) → laboratory (courier, cold pack, 7 d) → assay.
- Assay date
- 26 Jul 2025
- Submitted to the index
- 08 Aug 2025
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- METHOD LIMITED
Annotations 2
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 QSC-2502-D5359 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018623 | QSC-2502-D5359 | Janoshik | 2025-Q3 | 97.94 | 6.75 | 95.3 | Buyer-sourced | 0 | PASS |
| AX-2025-018625 | QSC-2502-D5359 | Janoshik | 2025-Q3 | 98.00 | 7.48 | 89.2 | Buyer-sourced | 1 | MARGINAL |
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-2026-041599 | CJC-1295 (no DAC) | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 97.96 | 3.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-041601 | CJC-1295 (no DAC) | QSC-2606-V7416 | Kestrel | 2026-Q3 | 98.33 | 4.10 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041602 | CJC-1295 (no DAC) | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 98.36 | 3.38 | 101.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041477 | Triptorelin | QSC-2607-C5749 | Nordanalyt | 2026-Q3 | 99.53 | 3.42 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041600 | CJC-1295 (no DAC) | QSC-2606-V7416 | Nordanalyt | 2026-Q3 | 97.74 | 4.91 | 100.9 | Buyer-sourced | 1 | FAIL |
| AX-2026-041603 | CJC-1295 (no DAC) | QSC-2606-V7416 | PeptideMeter | 2026-Q3 | 98.43 | 4.20 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041606 | CJC-1295 (no DAC) | QSC-2606-V7416 | Janoshik | 2026-Q3 | 98.03 | 3.58 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041585 | Liraglutide | QSC-2605-W7381 | Medutest | 2026-Q3 | 99.59 | 5.09 | 92.8 | Laboratory-retained | 0 | PASS |