AX-2025-021070
Hexarelin · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2501-B4807
- Report ID
- AX-2025-021070
- Compound
- Hexarelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2501-B4807
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 16 May 2025
- Submitted
- 17 May 2025
- Quarter
- 2025-Q2
- Submitter
- Contributor #B-5903
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the growth-hormone axis 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 | 98.47 | % area | ≥ 99.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 1.53 | % area | ≤ 1.0 | FAIL |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 0.78 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 886.4602 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 886.4600 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.2 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.92 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.56 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.25 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.851 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 98.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.52 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.63 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.93 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.44 | EU/mg | ≤ 5.0 | PASS |
| 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 | 4.90 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 8.98 | min | 8.92 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.87 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 83,492 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs C-terminal free acid (+1 Da) | 1.26 | — | 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 | Hexarelin — main peak | 8.98 | 4,785,947 | 98.47 | — |
| 2 | oxidised Trp (+16 Da) | 8.64 | 37,910 | 0.78 | +15.995 |
| 3 | C-terminal free acid (+1 Da) | 9.14 | 20,899 | 0.43 | +0.984 |
| 4 | des-methyl hexarelin (GHRP-6, −14 Da) | 8.50 | 10,207 | 0.21 | -14.016 |
| 5 | des-Lys (−128 Da) | 8.76 | 5,346 | 0.11 | -128.095 |
| 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 886.4602 Da, computed from C47H58N12O6. 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 (%) |
|---|---|---|---|---|
| 2+ | 444.2374 | 444.2373 | -0.0001 | 52.1 |
| 1+ | 887.4675 | 887.4673 | -0.0002 | 100.0 |
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 | 5.52 |
| Counter-ion (acetate) | ion chromatography | 4.63 |
| Residual solvent + inorganic residue | estimated | 0.93 |
| Total peptide content | by difference | 88.92 |
| 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) | 98.31 | 98.47 | divergence +0.34 pp vs batch median |
| Total impurities (% area) | 1.69 | 1.53 | |
| Largest single impurity (% area) | 0.62 | 0.78 | |
| Water (%) | not stated | 5.52 | |
| Counter-ion (%) | not stated | 4.63 | |
| Peptide content (%w/w) | not stated | 88.92 | |
| Endotoxin (EU/mg) | not stated | 0.44 | |
| 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, 9 d) → assay. Submitter did not handle the vial.
- Assay date
- 16 May 2025
- Submitted to the index
- 17 May 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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 BCH-2501-B4807 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021069 | BCH-2501-B4807 | PeptideMeter | 2025-Q2 | 97.69 | 5.98 | 91.4 | Buyer-sourced | 0 | FAIL |
| AX-2025-021071 | BCH-2501-B4807 | PeptideMeter | 2025-Q2 | 97.97 | 5.66 | 105.6 | Buyer-sourced | 0 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042177 | JEEP | JEEP-2608-Y9547 | Janoshik | 2026-Q3 | 99.90 | 3.42 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042178 | JEEP | JEEP-2608-Y9547 | VendorInvestigate | 2026-Q3 | 99.68 | 4.03 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043097 | KP | KP-2604-X5990 | Medutest | 2026-Q2 | 99.55 | 2.60 | — | Laboratory-retained | 0 | PASS |
| AX-2026-043253 | CPC | CPC-2511-F9455 | Janoshik | 2026-Q2 | 98.53 | 6.11 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043098 | KP | KP-2604-X5990 | PeptideMeter | 2026-Q2 | 98.66 | 3.14 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042366 | Homopeptide | HOMO-2602-R3080 | Janoshik | 2026-Q2 | 99.55 | 4.14 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042365 | Homopeptide | HOMO-2602-R3080 | PeptideMeter | 2026-Q2 | 99.66 | 4.44 | 94.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043100 | KP | KP-2604-X5990 | Janoshik | 2026-Q2 | 98.82 | 3.57 | 92.0 | Buyer-sourced | 0 | FAIL |
| 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 |