AX-2026-042811
Retatrutide · 20 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2603-M1446
- Report ID
- AX-2026-042811
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2603-M1446
- Declared label claim
- 20mg
- Laboratory
- Medutest
- Assay date
- 18 May 2026
- Submitted
- 21 May 2026
- Quarter
- 2026-Q2
- Submitter
- k.weiss
- 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 | 97.10 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.90 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 1.04 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 4728.4828 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 85.92 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.43 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 24.12 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 20.123 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.99 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.91 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.18 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.04 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | Growth detected at 6 d — Bacillus sp. | — | no growth | FAIL |
| 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 | 3.23 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 17.62 | min | 17.53 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.23 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 50,546 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.57 | — | 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 | 17.62 | 4,719,361 | 97.10 | — |
| 2 | oxidised Trp (+16 Da) | 17.07 | 50,547 | 1.04 | +15.995 |
| 3 | truncated (5-39) | 16.02 | 36,938 | 0.76 | -428.201 |
| 4 | incomplete Fmoc removal (+222 Da) | 19.63 | 31,592 | 0.65 | +222.068 |
| 5 | [D-Aib2]-diastereomer | 17.44 | 10,693 | 0.22 | 0.000 |
| 6 | C18 diacid regioisomer | 18.10 | 6,318 | 0.13 | 0.000 |
| 7 | aspartimide (−18 Da) | 18.21 | 4,860 | 0.10 | -18.011 |
| 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 | 8.0 |
| 6+ | 789.0885 | 789.0877 | -0.0008 | 49.5 |
| 5+ | 946.7047 | 946.7038 | -0.0009 | 100.0 |
| 4+ | 1183.1291 | 1183.1280 | -0.0011 | 56.5 |
| 3+ | 1577.1696 | 1577.1682 | -0.0014 | 8.5 |
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 | 3.99 |
| Counter-ion (TFA) | ion chromatography | 9.91 |
| Residual solvent + inorganic residue | estimated | 0.18 |
| Total peptide content | by difference | 85.92 |
| 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) | 98.26 | 97.10 | divergence +0.47 pp vs batch median |
| Total impurities (% area) | 1.74 | 2.90 | |
| Largest single impurity (% area) | 1.28 | 1.04 | |
| Water (%) | 3.7 | 3.99 | |
| Counter-ion (%) | not stated | 9.91 | |
| Peptide content (%w/w) | not stated | 85.92 | |
| Endotoxin (EU/mg) | not stated | 1.04 | |
| 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 (34 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 18 May 2026
- Submitted to the index
- 21 May 2026
- 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 GGPE-2603-M1446 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042807 | GGPE-2603-M1446 | Nordanalyt | 2026-Q2 | 97.89 | 4.00 | 96.0 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042808 | GGPE-2603-M1446 | Janoshik | 2026-Q2 | 98.19 | 4.08 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042809 | GGPE-2603-M1446 | VendorInvestigate | 2026-Q2 | 97.14 | 4.06 | 93.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042810 | GGPE-2603-M1446 | PeptideMeter | 2026-Q2 | 97.79 | 3.88 | 98.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042812 | GGPE-2603-M1446 | PeptideMeter | 2026-Q2 | 97.42 | 4.07 | 94.1 | Buyer-sourced | 2 | FAIL |
| AX-2026-042813 | GGPE-2603-M1446 | Medutest | 2026-Q2 | 98.52 | 4.12 | 106.4 | 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-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |