AX-2025-021105
Retatrutide · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2412-Y5177
- Report ID
- AX-2025-021105
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2412-Y5177
- Declared label claim
- 5mg
- Laboratory
- PeptideMeter
- Assay date
- 09 Apr 2025
- Submitted
- 10 Apr 2025
- Quarter
- 2025-Q2
- Submitter
- s.baptista
- 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 | 97.02 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.98 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid regioisomer | 1.98 | % 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) | 4728.5089 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +4.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.10 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.44 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.94 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.135 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 102.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.01 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.39 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.50 | % | — | 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 cake, partially collapsed | — | white to off-white intact cake | FAIL |
| 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 | 3.29 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 19.55 | min | 19.44 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.18 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 54,783 | — | ≥ 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 | 19.55 | 4,715,473 | 97.02 | — |
| 2 | C18 diacid regioisomer | 20.09 | 96,234 | 1.98 | 0.000 |
| 3 | oxidised Trp (+16 Da) | 18.93 | 19,927 | 0.41 | +15.995 |
| 4 | [D-Aib2]-diastereomer | 19.34 | 15,067 | 0.31 | 0.000 |
| 5 | truncated (5-39) | 17.76 | 6,804 | 0.14 | -428.201 |
| 6 | des-Aib20 analogue | 19.14 | 3,888 | 0.08 | -85.053 |
| 7 | retatrutide dimer | 23.40 | 2,916 | 0.06 | +4728.487 |
| 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 | 676.5085 | 0.0031 | 7.6 |
| 6+ | 789.0885 | 789.0921 | 0.0036 | 49.5 |
| 5+ | 946.7047 | 946.7091 | 0.0044 | 100.0 |
| 4+ | 1183.1291 | 1183.1345 | 0.0054 | 52.7 |
| 3+ | 1577.1696 | 1577.1769 | 0.0073 | 8.8 |
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 | 4.01 |
| Counter-ion (TFA) | ion chromatography | 6.39 |
| Residual solvent + inorganic residue | estimated | 0.50 |
| Total peptide content | by difference | 89.10 |
| 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) | 97.16 | 97.02 | divergence +0.14 pp vs batch median |
| Total impurities (% area) | 2.84 | 2.98 | |
| Largest single impurity (% area) | 1.42 | 1.98 | |
| Water (%) | not stated | 4.01 | |
| Counter-ion (%) | 7.5 | 6.39 | |
| Peptide content (%w/w) | 88.4 | 89.10 | |
| 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, 9 d) → laboratory (courier, cold pack, 7 d) → assay.
- Assay date
- 09 Apr 2025
- Submitted to the index
- 10 Apr 2025
- 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 BCH-2412-Y5177 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021103 | BCH-2412-Y5177 | Kestrel | 2025-Q2 | 98.34 | 3.49 | 106.8 | Buyer-sourced | 0 | PASS |
| AX-2025-021104 | BCH-2412-Y5177 | PeptideMeter | 2025-Q2 | 96.81 | 3.75 | 104.5 | 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-2026-043445 | BPC-157 | BCH-2603-G4350 | Nordanalyt | 2026-Q3 | 98.42 | 4.87 | 93.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043440 | BPC-157 | BCH-2603-G4350 | VendorInvestigate | 2026-Q3 | 98.61 | 4.11 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043442 | BPC-157 | BCH-2603-G4350 | Janoshik | 2026-Q3 | 98.65 | 4.78 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043471 | CJC-1295 with DAC | BCH-2607-H5235 | Janoshik | 2026-Q3 | 97.46 | 5.48 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043477 | CJC-1295 with DAC | BCH-2607-H5235 | VendorInvestigate | 2026-Q3 | 97.62 | 5.32 | 99.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043449 | BPC-157 | BCH-2603-G4350 | Kestrel | 2026-Q3 | 99.74 | 4.92 | 91.3 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043448 | BPC-157 | BCH-2603-G4350 | Janoshik | 2026-Q3 | 98.55 | 4.69 | 106.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043470 | CJC-1295 with DAC | BCH-2607-H5235 | Janoshik | 2026-Q3 | 97.76 | 6.11 | 99.3 | Supplier-supplied | 1 | MARGINAL |