AX-2024-004995
Retatrutide · 12 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2404-K1160
- Report ID
- AX-2024-004995
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2404-K1160
- Declared label claim
- 12mg
- Laboratory
- PeptideMeter
- Assay date
- 27 Aug 2024
- Submitted
- 03 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- custom_synth
- 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, 28 min gradient, 214 nm | 97.76 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.24 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — incomplete Fmoc removal (+222 Da) | 1.61 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4728.4871 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4728.3840 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -21.8 | ppm | ± 15 | FAIL |
| Total peptide content | by difference from the gravimetric mass balance | 84.61 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.71 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 14.26 | mg | 12 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 11.794 | mg | 12 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 98.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.59 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.89 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.91 | % | — | 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 | 3.47 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 19.39 | min | 19.44 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.17 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 47,347 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.56 | — | 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 | 19.39 | 4,751,439 | 97.76 | — |
| 2 | incomplete Fmoc removal (+222 Da) | 21.64 | 78,251 | 1.61 | +222.068 |
| 3 | [D-Aib2]-diastereomer | 19.18 | 15,553 | 0.32 | 0.000 |
| 4 | C18 diacid regioisomer | 19.93 | 8,749 | 0.18 | 0.000 |
| 5 | aspartimide (−18 Da) | 20.05 | 4,374 | 0.09 | -18.011 |
| 6 | oxidised Trp (+16 Da) | 18.77 | 1,458 | 0.03 | +15.995 |
| 7 | des-Aib20 analogue | 18.98 | 486 | 0.01 | -85.053 |
| 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 | 676.4907 | -0.0147 | 9.0 |
| 6+ | 789.0885 | 789.0713 | -0.0172 | 57.5 |
| 5+ | 946.7047 | 946.6841 | -0.0206 | 100.0 |
| 4+ | 1183.1291 | 1183.1033 | -0.0258 | 56.3 |
| 3+ | 1577.1696 | 1577.1353 | -0.0343 | 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 | 4.59 |
| Counter-ion (TFA) | ion chromatography | 9.89 |
| Residual solvent + inorganic residue | estimated | 0.91 |
| Total peptide content | by difference | 84.61 |
| 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) | 98.61 | 97.76 | divergence +0.59 pp vs batch median |
| Total impurities (% area) | 1.39 | 2.24 | |
| Largest single impurity (% area) | 0.59 | 1.61 | |
| Water (%) | 3.8 | 4.59 | |
| Counter-ion (%) | not stated | 9.89 | |
| Peptide content (%w/w) | 91.4 | 84.61 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 11 d) → assay. Submitter did not handle the vial.
- Assay date
- 27 Aug 2024
- Submitted to the index
- 03 Sep 2024
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 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 GGPE-2404-K1160 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004989 | GGPE-2404-K1160 | Kestrel | 2024-Q3 | 99.20 | 5.05 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-004990 | GGPE-2404-K1160 | Janoshik | 2024-Q3 | 98.02 | 4.78 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-004991 | GGPE-2404-K1160 | Janoshik | 2024-Q3 | 98.03 | 4.58 | 103.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-004992 | GGPE-2404-K1160 | Janoshik | 2024-Q3 | 98.38 | 4.68 | 106.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-004993 | GGPE-2404-K1160 | Janoshik | 2024-Q3 | 98.31 | 4.50 | 106.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-004994 | GGPE-2404-K1160 | VendorInvestigate | 2024-Q3 | 97.70 | 5.47 | 101.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-004996 | GGPE-2404-K1160 | Janoshik | 2024-Q3 | 97.45 | 4.87 | 99.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-004997 | GGPE-2404-K1160 | PeptideMeter | 2024-Q3 | 97.50 | 4.92 | 106.0 | Supplier-supplied | 1 | 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 |