AX-2025-021352
AOD-9604 · 2 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2504-B8271
- Report ID
- AX-2025-021352
- Compound
- AOD-9604
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2504-B8271
- Declared label claim
- 2mg
- Laboratory
- Medutest
- Assay date
- 15 Aug 2025
- Submitted
- 24 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- d.sorensen
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the metabolic and mitochondrial peptides 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, 25 min gradient, 214 nm | 99.19 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.81 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — open-chain (reduced disulfide, +2 Da) | 0.46 | % 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 | 93.07 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 92.32 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.02 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.865 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 93.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 2.26 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.86 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.81 | % | — | 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 | 5.41 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 9.57 | min | 9.55 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.02 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 69,822 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs Met sulfoxide (+16 Da) | 2.47 | — | 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 | AOD-9604 — main peak | 9.57 | 4,820,941 | 99.19 | — |
| 2 | open-chain (reduced disulfide, +2 Da) | 9.06 | 22,357 | 0.46 | +2.016 |
| 3 | des-Tyr AOD (−163 Da) | 8.87 | 10,207 | 0.21 | -163.063 |
| 4 | AOD dimer | 11.32 | 3,888 | 0.08 | +1813.852 |
| 5 | Met sulfoxide (+16 Da) | 9.20 | 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 | 2.26 |
| Counter-ion (acetate) | ion chromatography | 3.86 |
| Residual solvent + inorganic residue | estimated | 0.81 |
| Total peptide content | by difference | 93.07 |
| 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) | 98.02 | 99.19 | divergence -0.75 pp vs batch median |
| Total impurities (% area) | 1.98 | 0.81 | |
| Largest single impurity (% area) | not stated | 0.46 | |
| Water (%) | 0.9 | 2.26 | |
| Counter-ion (%) | not stated | 3.86 | |
| Peptide content (%w/w) | not stated | 93.07 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
- Assay date
- 15 Aug 2025
- Submitted to the index
- 24 Aug 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Annotations 1
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 BCH-2504-B8271 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021347 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 98.57 | 3.01 | 97.6 | Supplier-supplied | 0 | PASS |
| AX-2025-021348 | BCH-2504-B8271 | VendorInvestigate | 2025-Q3 | 97.76 | 2.70 | 105.1 | Buyer-sourced | 0 | FAIL |
| AX-2025-021349 | BCH-2504-B8271 | Medutest | 2025-Q3 | 98.89 | 2.91 | 97.7 | Buyer-sourced | 0 | PASS |
| AX-2025-021350 | BCH-2504-B8271 | PeptideMeter | 2025-Q3 | 98.72 | 3.08 | — | Laboratory-retained | 0 | PASS |
| AX-2025-021351 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 99.05 | 2.77 | 91.4 | Buyer-sourced | 0 | PASS |
| AX-2025-021353 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 98.81 | 2.77 | — | Supplier-supplied | 0 | PASS |
| AX-2025-021354 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 98.77 | 2.64 | 89.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021355 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 99.35 | 2.35 | 97.0 | Supplier-supplied | 0 | PASS |
| AX-2025-021356 | BCH-2504-B8271 | VendorInvestigate | 2025-Q3 | 98.57 | 3.13 | 90.7 | Buyer-sourced | 0 | PASS |
| AX-2025-021357 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 98.77 | 2.44 | — | Buyer-sourced | 0 | PASS |
| AX-2025-021358 | BCH-2504-B8271 | VendorInvestigate | 2025-Q3 | 98.56 | 2.61 | — | Buyer-sourced | 0 | PASS |
| AX-2025-021359 | BCH-2504-B8271 | Janoshik | 2025-Q3 | 98.64 | 2.68 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042460 | HJ | HJ-2601-N4296 | Janoshik | 2026-Q2 | 99.25 | 5.70 | 95.3 | Buyer-sourced | 0 | PASS |
| AX-2026-042462 | HJ | HJ-2601-N4296 | Kestrel | 2026-Q2 | 99.49 | 5.15 | 93.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042464 | HJ | HJ-2601-N4296 | Janoshik | 2026-Q2 | 99.04 | 5.21 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042458 | HJ | HJ-2601-N4296 | Janoshik | 2026-Q2 | 98.94 | 6.09 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042463 | HJ | HJ-2601-N4296 | VendorInvestigate | 2026-Q2 | 98.84 | 5.24 | 96.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042457 | HJ | HJ-2601-N4296 | Medutest | 2026-Q2 | 99.43 | 5.12 | 103.4 | Buyer-sourced | 0 | PASS |
| AX-2026-042461 | HJ | HJ-2601-N4296 | Medutest | 2026-Q2 | 98.98 | 5.22 | 107.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042466 | HJ | HJ-2601-N4296 | Nordanalyt | 2026-Q2 | 99.05 | 5.35 | 89.6 | Buyer-sourced | 1 | MARGINAL |
| 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 |