AX-2025-021298
AOD-9604 · 2 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2504-B8049
- Report ID
- AX-2025-021298
- Compound
- AOD-9604
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2504-B8049
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 16 Aug 2025
- Submitted
- 10 Sep 2025
- Quarter
- 2025-Q3
- Submitter
- lu.ndiaye
- 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, 30 min gradient, 214 nm | 98.75 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.25 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — open-chain (reduced disulfide, +2 Da) | 0.71 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1815.8672 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1815.8670 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.1 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.55 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.43 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.20 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.945 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 2.71 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.85 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.89 | % | — | 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 | 4.98 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 11.27 | min | 11.28 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.98 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 67,011 | — | ≥ 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 | 11.27 | 4,799,556 | 98.75 | — |
| 2 | open-chain (reduced disulfide, +2 Da) | 10.66 | 34,508 | 0.71 | +2.016 |
| 3 | des-Tyr AOD (−163 Da) | 10.43 | 15,553 | 0.32 | -163.063 |
| 4 | AOD dimer | 13.37 | 5,832 | 0.12 | +1813.852 |
| 5 | Met sulfoxide (+16 Da) | 10.83 | 4,860 | 0.10 | +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.
Mass spectrum and identity
Theoretical monoisotopic mass 1815.8672 Da, computed from C78H123N23O23S2. 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 (%) |
|---|---|---|---|---|
| 4+ | 454.9741 | 454.9740 | -0.0001 | 8.8 |
| 3+ | 606.2963 | 606.2963 | -0.0000 | 55.9 |
| 2+ | 908.9409 | 908.9408 | -0.0001 | 100.0 |
| 1+ | 1816.8745 | 1816.8743 | -0.0002 | 52.1 |
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 | 2.71 |
| Counter-ion (acetate) | ion chromatography | 6.85 |
| Residual solvent + inorganic residue | estimated | 0.89 |
| Total peptide content | by difference | 89.55 |
| 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) | 98.87 | 98.75 | divergence +0.02 pp vs batch median |
| Total impurities (% area) | 1.13 | 1.25 | |
| Largest single impurity (% area) | not stated | 0.71 | |
| Water (%) | 1.5 | 2.71 | |
| Counter-ion (%) | not stated | 6.85 | |
| Peptide content (%w/w) | 93.7 | 89.55 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 6 d) → assay. Submitter did not handle the vial.
- Assay date
- 16 Aug 2025
- Submitted to the index
- 10 Sep 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-2504-B8049 n=4
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021295 | BCH-2504-B8049 | Medutest | 2025-Q3 | 98.96 | 3.54 | — | Supplier-supplied | 0 | PASS |
| AX-2025-021296 | BCH-2504-B8049 | Janoshik | 2025-Q3 | 98.96 | 2.53 | 97.1 | Supplier-supplied | 0 | PASS |
| AX-2025-021297 | BCH-2504-B8049 | Janoshik | 2025-Q3 | 98.30 | 2.91 | 97.5 | Supplier-supplied | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042300 | HJ | HJ-2601-N2483 | Janoshik | 2026-Q2 | 98.77 | 5.32 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042297 | HJ | HJ-2601-N2483 | Medutest | 2026-Q2 | 99.00 | 4.72 | 99.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042299 | HJ | HJ-2601-N2483 | VendorInvestigate | 2026-Q2 | 98.14 | 5.21 | 103.7 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042296 | HJ | HJ-2601-N2483 | Janoshik | 2026-Q2 | 98.85 | 5.76 | 97.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042301 | HJ | HJ-2601-N2483 | VendorInvestigate | 2026-Q2 | 98.60 | 5.36 | 97.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042298 | HJ | HJ-2601-N2483 | Janoshik | 2026-Q2 | 99.02 | 5.14 | 96.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042295 | HJ | HJ-2601-N2483 | Medutest | 2026-Q2 | 98.88 | 5.80 | 93.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041474 | QYB | QYB-2508-E6017 | Janoshik | 2026-Q1 | 99.62 | 3.75 | — | Supplier-supplied | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043574 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.75 | 8.85 | 97.9 | Supplier-supplied | 1 | FAIL |
| AX-2026-043503 | BPC-157 | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.46 | 4.32 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043575 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.44 | 9.19 | 104.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043539 | CJC-1295 with DAC | BCH-2607-H7307 | Janoshik | 2026-Q3 | 98.12 | 5.78 | 100.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043504 | BPC-157 | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.38 | 4.45 | 95.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043502 | BPC-157 | BCH-2603-G6422 | PeptideMeter | 2026-Q3 | 97.72 | 4.86 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043501 | BPC-157 | BCH-2603-G6422 | PeptideMeter | 2026-Q3 | 98.37 | 4.75 | 100.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043573 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.47 | 8.59 | — | Supplier-supplied | 1 | FAIL |