AX-2025-020033
Retatrutide · 10 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2506-C7220
- Report ID
- AX-2025-020033
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2506-C7220
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 31 Jul 2025
- Submitted
- 20 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- m.lindholm
- 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 | 98.55 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.45 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — des-Aib20 analogue | 0.72 | % 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) | 4728.4824 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -1.0 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.85 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.58 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.71 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.139 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 101.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.97 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.74 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.44 | % | — | 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 with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.88 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 20.79 | min | 20.71 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.06 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 64,223 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.65 | — | 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 | 20.79 | 4,789,836 | 98.55 | — |
| 2 | des-Aib20 analogue | 20.35 | 34,994 | 0.72 | -85.053 |
| 3 | aspartimide (−18 Da) | 21.50 | 18,469 | 0.38 | -18.011 |
| 4 | truncated (5-39) | 18.87 | 7,776 | 0.16 | -428.201 |
| 5 | [D-Aib2]-diastereomer | 20.57 | 6,318 | 0.13 | 0.000 |
| 6 | oxidised Trp (+16 Da) | 20.13 | 2,430 | 0.05 | +15.995 |
| 7 | retatrutide dimer | 24.91 | 486 | 0.01 | +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 | 676.5048 | -0.0006 | 7.9 |
| 6+ | 789.0885 | 789.0877 | -0.0008 | 53.0 |
| 5+ | 946.7047 | 946.7038 | -0.0009 | 100.0 |
| 4+ | 1183.1291 | 1183.1279 | -0.0012 | 51.6 |
| 3+ | 1577.1696 | 1577.1681 | -0.0015 | 8.6 |
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 | 4.97 |
| Counter-ion (TFA) | ion chromatography | 6.74 |
| Residual solvent + inorganic residue | estimated | 0.44 |
| Total peptide content | by difference | 87.85 |
| 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) | 99.0 | 98.55 | divergence +0.46 pp vs batch median |
| Total impurities (% area) | 1.00 | 1.45 | |
| Largest single impurity (% area) | 0.65 | 0.72 | |
| Water (%) | not stated | 4.97 | |
| Counter-ion (%) | not stated | 6.74 | |
| Peptide content (%w/w) | 91.7 | 87.85 | |
| Endotoxin (EU/mg) | 0.52 | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 3 d) → assay. Submitter did not handle the vial.
- Assay date
- 31 Jul 2025
- Submitted to the index
- 20 Aug 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot ERP-2506-C7220 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020034 | ERP-2506-C7220 | Janoshik | 2025-Q3 | 98.26 | 5.59 | 100.9 | Supplier-supplied | 3 | MARGINAL |
| AX-2025-020035 | ERP-2506-C7220 | Kestrel | 2025-Q3 | 98.54 | 4.95 | — | Buyer-sourced | 3 | FAIL |
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-2026-042574 | TB-500 | ERP-2605-S8022 | VendorInvestigate | 2026-Q3 | 99.54 | 2.91 | 96.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042535 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 99.19 | 3.89 | 92.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042577 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.51 | 3.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042542 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.54 | 4.58 | 103.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042547 | Survodutide | ERP-2605-E7682 | PeptideMeter | 2026-Q3 | 98.25 | 5.44 | 93.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042540 | Tesamorelin | ERP-2604-W7280 | Kestrel | 2026-Q3 | 99.72 | 3.47 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042575 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.93 | 3.36 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-042539 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.77 | 4.30 | 89.9 | Buyer-sourced | 2 | MARGINAL |