AX-2025-018554
Retatrutide · 12 mg declared · ChinaPeptides Co., Ltd. (QYAOBIO) · lot QYB-2507-R4727
- Report ID
- AX-2025-018554
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- QYB — ChinaPeptides Co., Ltd. (QYAOBIO)
- Batch / lot
- QYB-2507-R4727
- Declared label claim
- 12mg
- Laboratory
- PeptideMeter
- Assay date
- 23 Dec 2025
- Submitted
- 30 Dec 2025
- Quarter
- 2025-Q4
- Submitter
- mk677_standard
- 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, 28 min gradient, 214 nm | 98.23 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.77 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — [D-Aib2]-diastereomer | 0.69 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 89.92 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.33 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 14.27 | mg | 12 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 12.605 | mg | 12 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.72 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 5.96 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.40 | % | — | 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 | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.53 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 19.66 | min | 19.44 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.16 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 55,902 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.60 | — | 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 | 19.66 | 4,774,283 | 98.23 | — |
| 2 | [D-Aib2]-diastereomer | 19.45 | 33,536 | 0.69 | 0.000 |
| 3 | C18 diacid regioisomer | 20.20 | 31,592 | 0.65 | 0.000 |
| 4 | retatrutide dimer | 23.51 | 9,235 | 0.19 | +4728.487 |
| 5 | des-Aib20 analogue | 19.25 | 4,860 | 0.10 | -85.053 |
| 6 | truncated (5-39) | 17.87 | 3,888 | 0.08 | -428.201 |
| 7 | oxidised Trp (+16 Da) | 19.04 | 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.
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 | 3.72 |
| Counter-ion (TFA) | ion chromatography | 5.96 |
| Residual solvent + inorganic residue | estimated | 0.40 |
| Total peptide content | by difference | 89.92 |
| 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) | 98.79 | 98.23 | divergence +0.36 pp vs batch median |
| Total impurities (% area) | 1.21 | 1.77 | |
| Largest single impurity (% area) | not stated | 0.69 | |
| Water (%) | 2.4 | 3.72 | |
| Counter-ion (%) | not stated | 5.96 | |
| Peptide content (%w/w) | 92.8 | 89.92 | |
| 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 → submitter (ambient, 34 d) → laboratory (courier, cold pack, 10 d) → assay.
- Assay date
- 23 Dec 2025
- Submitted to the index
- 30 Dec 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
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-2507-R4727 n=15
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018549 | QYB-2507-R4727 | Medutest | 2025-Q4 | 98.65 | 4.61 | 101.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041413 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.35 | 4.68 | — | Buyer-sourced | 0 | PASS |
| AX-2025-018550 | QYB-2507-R4727 | Nordanalyt | 2025-Q4 | 98.49 | 3.85 | 89.7 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-018551 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.73 | 4.19 | 94.0 | Buyer-sourced | 0 | PASS |
| AX-2025-018552 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.47 | 4.11 | — | Buyer-sourced | 0 | PASS |
| AX-2025-018553 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.21 | 3.81 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041414 | QYB-2507-R4727 | Nordanalyt | 2025-Q4 | 98.48 | 4.59 | — | Buyer-sourced | 0 | PASS |
| AX-2025-018555 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 99.02 | 3.96 | 101.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041415 | QYB-2507-R4727 | PeptideMeter | 2025-Q4 | 98.29 | 4.02 | 102.2 | Buyer-sourced | 0 | PASS |
| AX-2025-018556 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.29 | 4.29 | 97.1 | Buyer-sourced | 0 | PASS |
| AX-2025-018557 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.34 | 4.18 | 106.1 | Buyer-sourced | 0 | PASS |
| AX-2025-018558 | QYB-2507-R4727 | Janoshik | 2025-Q4 | 98.80 | 4.63 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041416 | QYB-2507-R4727 | Kestrel | 2025-Q4 | 98.43 | 4.58 | 102.7 | Buyer-sourced | 0 | PASS |
| AX-2025-018559 | QYB-2507-R4727 | PeptideMeter | 2025-Q4 | 97.75 | 3.84 | — | Buyer-sourced | 0 | PASS |
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-2026-041471 | PT-141 (Bremelanotide) | QYB-2607-L4875 | Janoshik | 2026-Q3 | 99.72 | 3.75 | 101.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041377 | Ipamorelin | QYB-2605-H3558 | Nordanalyt | 2026-Q3 | 99.93 | 4.35 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041427 | Retatrutide | QYB-2604-B4920 | PeptideMeter | 2026-Q3 | 97.93 | 2.45 | 101.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041428 | Retatrutide | QYB-2604-B4920 | Janoshik | 2026-Q3 | 98.35 | 3.20 | — | Laboratory-retained | 0 | PASS |
| AX-2026-041473 | PT-141 (Bremelanotide) | QYB-2607-L4875 | PeptideMeter | 2026-Q3 | 99.58 | 3.74 | 94.4 | Buyer-sourced | 0 | PASS |
| AX-2026-041472 | PT-141 (Bremelanotide) | QYB-2607-L4875 | PeptideMeter | 2026-Q3 | 99.93 | 3.94 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041429 | Retatrutide | QYB-2604-B4920 | Medutest | 2026-Q3 | 98.53 | 2.69 | 99.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041431 | Retatrutide | QYB-2604-B4920 | Janoshik | 2026-Q3 | 98.63 | 2.32 | 94.2 | Buyer-sourced | 0 | PASS |