AX-2025-019311
Retatrutide · 15 mg declared · AmbioPharm, Inc. · lot AMB-2502-A6319
- Report ID
- AX-2025-019311
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- AMB — AmbioPharm, Inc.
- Batch / lot
- AMB-2502-A6319
- Declared label claim
- 15mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 16 Sep 2025
- Submitted
- 07 Oct 2025
- Quarter
- 2025-Q3
- Submitter
- f.ramos
- 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, 35 min gradient, 214 nm | 98.15 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.85 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid regioisomer | 1.17 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 88.63 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.99 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 18.23 | mg | 15 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 15.858 | mg | 15 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.87 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.14 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.36 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| 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 | 4.12 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 23.98 | min | 23.89 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.19 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 54,028 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib2]-diastereomer | 0.61 | — | 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 | 23.98 | 4,770,394 | 98.15 | — |
| 2 | C18 diacid regioisomer | 24.66 | 56,866 | 1.17 | 0.000 |
| 3 | aspartimide (−18 Da) | 24.81 | 16,039 | 0.33 | -18.011 |
| 4 | des-Aib20 analogue | 23.47 | 9,721 | 0.20 | -85.053 |
| 5 | [D-Aib2]-diastereomer | 23.72 | 3,402 | 0.07 | 0.000 |
| 6 | incomplete Fmoc removal (+222 Da) | 26.79 | 1,944 | 0.04 | +222.068 |
| 7 | truncated (5-39) | 21.74 | 1,944 | 0.04 | -428.201 |
| 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 | 4.87 |
| Counter-ion (TFA) | ion chromatography | 6.14 |
| Residual solvent + inorganic residue | estimated | 0.36 |
| Total peptide content | by difference | 88.63 |
| 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) | 98.06 | 98.15 | divergence -0.11 pp vs batch median |
| Total impurities (% area) | 1.94 | 1.85 | |
| Largest single impurity (% area) | 0.92 | 1.17 | |
| Water (%) | 2.4 | 4.87 | |
| Counter-ion (%) | 7.3 | 6.14 | |
| Peptide content (%w/w) | 89.7 | 88.63 | |
| 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
- Domestic warehouse despatch → submitter (2–8 °C, 13 d) → laboratory (courier, cold pack, 7 d) → assay.
- Assay date
- 16 Sep 2025
- Submitted to the index
- 07 Oct 2025
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations 2
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Related records
Same batch — lot AMB-2502-A6319 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019304 | AMB-2502-A6319 | Janoshik | 2025-Q3 | 98.67 | 4.31 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2025-019305 | AMB-2502-A6319 | Medutest | 2025-Q3 | 98.55 | 4.51 | 96.8 | Buyer-sourced | 0 | PASS |
| AX-2025-019306 | AMB-2502-A6319 | Janoshik | 2025-Q3 | 97.86 | 5.26 | 88.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-019307 | AMB-2502-A6319 | VendorInvestigate | 2025-Q3 | 98.16 | 4.61 | 89.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-019308 | AMB-2502-A6319 | Nordanalyt | 2025-Q3 | 98.26 | 4.87 | 104.6 | Buyer-sourced | 0 | PASS |
| AX-2025-019309 | AMB-2502-A6319 | PeptideMeter | 2025-Q3 | 98.02 | 4.49 | 90.0 | Buyer-sourced | 0 | PASS |
| AX-2025-019310 | AMB-2502-A6319 | PeptideMeter | 2025-Q3 | 98.18 | 4.72 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019312 | AMB-2502-A6319 | Janoshik | 2025-Q3 | 97.75 | 4.97 | 105.5 | Buyer-sourced | 0 | PASS |
| AX-2025-019313 | AMB-2502-A6319 | Janoshik | 2025-Q3 | 98.37 | 4.57 | — | 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-2026-042002 | Semaglutide | AMB-2607-N6274 | VendorInvestigate | 2026-Q3 | 98.23 | 6.37 | 97.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042012 | GHRP-6 | AMB-2603-S5667 | Janoshik | 2026-Q3 | 99.37 | 5.90 | 88.8 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-041974 | Tirzepatide | AMB-2603-C5112 | Nordanalyt | 2026-Q3 | 98.20 | 3.41 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041975 | Tirzepatide | AMB-2603-C5112 | Medutest | 2026-Q3 | 97.88 | 3.45 | 106.9 | Laboratory-retained | 0 | PASS |
| AX-2026-042005 | Semaglutide | AMB-2607-N6274 | PeptideMeter | 2026-Q3 | 98.09 | 6.48 | 98.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042008 | Epitalon | AMB-2602-Y6433 | Janoshik | 2026-Q3 | 99.30 | 8.75 | 105.1 | Buyer-sourced | 0 | PASS |
| AX-2026-042021 | TB-500 | AMB-2602-P5987 | VendorInvestigate | 2026-Q3 | 99.86 | 4.79 | 101.4 | Buyer-sourced | 0 | PASS |
| AX-2026-042015 | GHRP-6 | AMB-2603-S5667 | Janoshik | 2026-Q3 | 99.54 | 6.44 | 97.1 | Buyer-sourced | 0 | PASS |