AX-2025-021321
Retatrutide · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2412-Y7471
- Report ID
- AX-2025-021321
- Compound
- Retatrutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2412-Y7471
- Declared label claim
- 5mg
- Laboratory
- Janoshik Analytical
- Assay date
- 14 Jun 2025
- Submitted
- 19 Jun 2025
- Quarter
- 2025-Q2
- Submitter
- a.fontaine
- 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, 30 min gradient, 214 nm | 96.97 | % area | ≥ 96.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 3.03 | % area | ≤ 3.5 | PASS |
| Largest single impurity | RP-HPLC — C18 diacid regioisomer | 1.55 | % 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) | 4728.4743 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -2.7 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.74 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.05 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.51 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.741 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 94.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.14 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.72 | % | ≤ 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 | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.07 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 20.65 | min | 20.71 ± 0.50 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.89 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 52,047 | — | ≥ 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 | 20.65 | 4,713,043 | 96.97 | — |
| 2 | C18 diacid regioisomer | 21.23 | 75,335 | 1.55 | 0.000 |
| 3 | des-Aib20 analogue | 20.21 | 34,022 | 0.70 | -85.053 |
| 4 | incomplete Fmoc removal (+222 Da) | 23.06 | 15,553 | 0.32 | +222.068 |
| 5 | truncated (5-39) | 18.73 | 12,151 | 0.25 | -428.201 |
| 6 | oxidised Trp (+16 Da) | 19.99 | 6,804 | 0.14 | +15.995 |
| 7 | [D-Aib2]-diastereomer | 20.43 | 3,402 | 0.07 | 0.000 |
| 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 | 676.5036 | -0.0018 | 8.3 |
| 6+ | 789.0885 | 789.0863 | -0.0022 | 51.7 |
| 5+ | 946.7047 | 946.7021 | -0.0026 | 100.0 |
| 4+ | 1183.1291 | 1183.1259 | -0.0032 | 53.7 |
| 3+ | 1577.1696 | 1577.1654 | -0.0042 | 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 | 4.14 |
| Counter-ion (TFA) | ion chromatography | 6.72 |
| Residual solvent + inorganic residue | estimated | 0.40 |
| Total peptide content | by difference | 88.74 |
| 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) | 96.92 | 96.97 | divergence -0.14 pp vs batch median |
| Total impurities (% area) | 3.08 | 3.03 | |
| Largest single impurity (% area) | not stated | 1.55 | |
| Water (%) | not stated | 4.14 | |
| Counter-ion (%) | not stated | 6.72 | |
| Peptide content (%w/w) | 91.7 | 88.74 | |
| 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 → third-party forwarder (18 d) → laboratory (courier, cold pack, 7 d) → assay.
- Assay date
- 14 Jun 2025
- Submitted to the index
- 19 Jun 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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-Y7471 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021316 | BCH-2412-Y7471 | PeptideMeter | 2025-Q2 | 97.05 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2025-021317 | BCH-2412-Y7471 | Janoshik | 2025-Q2 | 97.11 | 3.53 | — | Buyer-sourced | 0 | PASS |
| AX-2025-021318 | BCH-2412-Y7471 | Medutest | 2025-Q2 | 97.12 | 3.68 | 97.9 | Buyer-sourced | 0 | PASS |
| AX-2025-021319 | BCH-2412-Y7471 | Janoshik | 2025-Q2 | 97.06 | 3.67 | 95.0 | Buyer-sourced | 0 | PASS |
| AX-2025-021320 | BCH-2412-Y7471 | Medutest | 2025-Q2 | 96.76 | 2.99 | 102.1 | Buyer-sourced | 0 | PASS |
| AX-2025-021322 | BCH-2412-Y7471 | Janoshik | 2025-Q2 | 97.16 | 3.76 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042354 | Homopeptide | HOMO-2605-V2905 | Janoshik | 2026-Q3 | 98.76 | 3.48 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042167 | TFC | TFC-2608-J7751 | Janoshik | 2026-Q3 | 98.43 | 4.37 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041532 | QYB | QYB-2602-G6086 | Janoshik | 2026-Q3 | 98.35 | 2.54 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041538 | QYB | QYB-2602-G6086 | Janoshik | 2026-Q3 | 98.58 | 3.53 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041454 | QYB | QYB-2604-B5438 | Janoshik | 2026-Q3 | 98.24 | 2.33 | 89.3 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041539 | QYB | QYB-2602-G6086 | PeptideMeter | 2026-Q3 | 97.92 | 3.62 | 91.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041455 | QYB | QYB-2604-B5438 | PeptideMeter | 2026-Q3 | 98.57 | 2.40 | 105.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042164 | TFC | TFC-2608-J7751 | Janoshik | 2026-Q3 | 98.14 | 4.31 | 105.7 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043691 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 98.66 | 5.12 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043693 | BPC-157 | BCH-2603-L7768 | PeptideMeter | 2026-Q3 | 97.82 | 5.21 | 94.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043686 | BPC-157 | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.64 | 5.27 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043695 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.61 | 5.42 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043726 | N-Acetyl Semax Amide | BCH-2602-E8475 | Janoshik | 2026-Q3 | 97.89 | 9.67 | 104.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043688 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.94 | 5.56 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043658 | BPC-157 | BCH-2603-G6644 | Janoshik | 2026-Q3 | 98.45 | 4.37 | 101.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043692 | BPC-157 | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.60 | 5.61 | — | Buyer-sourced | 0 | FAIL |