AX-2026-041519
Retatrutide · 20 mg declared · ChinaPeptides Co., Ltd. (QYAOBIO) · lot QYB-2602-R6263
- Report ID
- AX-2026-041519
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- QYB — ChinaPeptides Co., Ltd. (QYAOBIO)
- Batch / lot
- QYB-2602-R6263
- Declared label claim
- 20mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 05 Apr 2026
- Submitted
- 16 Apr 2026
- Quarter
- 2026-Q2
- Submitter
- me.hartmann
- 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, 15 min gradient, 214 nm | 99.34 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.66 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid regioisomer | 0.40 | % 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) | 4728.5098 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +4.8 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.89 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.31 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 21.42 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 18.702 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 93.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.33 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 5.45 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.33 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.22 | EU/mg | ≤ 5.0 | PASS |
| 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, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.32 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 11.23 | min | 11.18 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.12 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 60,956 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.59 | — | 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 | 11.23 | 4,828,232 | 99.34 | — |
| 2 | C18 diacid regioisomer | 11.52 | 19,441 | 0.40 | 0.000 |
| 3 | [D-Aib2]-diastereomer | 11.12 | 5,346 | 0.11 | 0.000 |
| 4 | des-Aib20 analogue | 11.01 | 2,916 | 0.06 | -85.053 |
| 5 | oxidised Trp (+16 Da) | 10.90 | 2,430 | 0.05 | +15.995 |
| 6 | incomplete Fmoc removal (+222 Da) | 12.44 | 1,944 | 0.04 | +222.068 |
| 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 | 676.5087 | 0.0033 | 8.7 |
| 6+ | 789.0885 | 789.0922 | 0.0037 | 60.9 |
| 5+ | 946.7047 | 946.7092 | 0.0045 | 100.0 |
| 4+ | 1183.1291 | 1183.1347 | 0.0056 | 61.1 |
| 3+ | 1577.1696 | 1577.1772 | 0.0076 | 8.1 |
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 | 6.33 |
| Counter-ion (TFA) | ion chromatography | 5.45 |
| Residual solvent + inorganic residue | estimated | 0.33 |
| Total peptide content | by difference | 87.89 |
| 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) | 98.60 | 99.34 | divergence +0.37 pp vs batch median |
| Total impurities (% area) | 1.40 | 0.66 | |
| Largest single impurity (% area) | 0.86 | 0.40 | |
| Water (%) | 3.9 | 6.33 | |
| Counter-ion (%) | 7.0 | 5.45 | |
| Peptide content (%w/w) | 88.5 | 87.89 | |
| Endotoxin (EU/mg) | 0.20 | 0.22 | |
| 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, 9 d) → assay. Submitter did not handle the vial.
- Assay date
- 05 Apr 2026
- Submitted to the index
- 16 Apr 2026
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- METHOD LIMITED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot QYB-2602-R6263 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041514 | QYB-2602-R6263 | Kestrel | 2026-Q2 | 98.93 | 5.27 | — | Supplier-supplied | 3 | FAIL |
| AX-2026-041515 | QYB-2602-R6263 | Janoshik | 2026-Q2 | 98.73 | 5.16 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041516 | QYB-2602-R6263 | PeptideMeter | 2026-Q2 | 97.91 | 5.52 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041517 | QYB-2602-R6263 | Janoshik | 2026-Q2 | 98.09 | 5.43 | 105.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041518 | QYB-2602-R6263 | Janoshik | 2026-Q2 | 97.87 | 5.72 | 101.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041520 | QYB-2602-R6263 | VendorInvestigate | 2026-Q2 | 97.53 | 5.39 | 100.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041521 | QYB-2602-R6263 | PeptideMeter | 2026-Q2 | 98.36 | 5.48 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041522 | QYB-2602-R6263 | PeptideMeter | 2026-Q2 | 97.87 | 5.49 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041523 | QYB-2602-R6263 | Janoshik | 2026-Q2 | 99.10 | 5.51 | 90.7 | 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-2026-041453 | Retatrutide | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 98.02 | 2.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041454 | Retatrutide | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.84 | 2.77 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041538 | Retatrutide | QYB-2602-G6308 | Medutest | 2026-Q3 | 98.50 | 2.85 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041456 | Retatrutide | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.23 | 3.24 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041452 | Retatrutide | QYB-2604-B5660 | Nordanalyt | 2026-Q3 | 98.50 | 3.36 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041427 | Ipamorelin | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 4.12 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041488 | PT-141 (Bremelanotide) | QYB-2607-L5615 | Janoshik | 2026-Q3 | 99.93 | 3.79 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041459 | Retatrutide | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 97.91 | 2.84 | 92.2 | Buyer-sourced | 1 | MARGINAL |