AX-2026-043541
Ipamorelin · 2 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2510-P7043
- Report ID
- AX-2026-043541
- Compound
- Ipamorelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2510-P7043
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 22 Jan 2026
- Submitted
- 01 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- m.kimani
- 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 | 99.50 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.50 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — [D-Trp]-epimer | 0.20 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 711.3856 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 711.3879 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +3.3 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.24 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.80 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.40 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.107 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.54 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 7.38 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.84 | % | — | 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 | 4.75 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 8.20 | min | 8.24 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.06 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 95,079 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 1.10 | — | 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 | Ipamorelin — main peak | 8.20 | 4,836,008 | 99.50 | — |
| 2 | [D-Trp]-epimer | 8.08 | 9,721 | 0.20 | 0.000 |
| 3 | C-terminal free acid (+1 Da) | 8.38 | 6,318 | 0.13 | +0.984 |
| 4 | oxidised Trp (+16 Da) | 7.86 | 4,374 | 0.09 | +15.995 |
| 5 | des-Lys (−128 Da) | 7.98 | 3,888 | 0.08 | -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 711.3856 Da, computed from C38H49N9O5. 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+ | 356.7001 | 356.7012 | 0.0011 | 59.9 |
| 1+ | 712.3929 | 712.3952 | 0.0023 | 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 | 3.54 |
| Counter-ion (acetate) | ion chromatography | 7.38 |
| Residual solvent + inorganic residue | estimated | 0.84 |
| Total peptide content | by difference | 88.24 |
| 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) | 99.5 | 99.50 | divergence +0.15 pp vs batch median |
| Total impurities (% area) | 0.50 | 0.50 | |
| Largest single impurity (% area) | not stated | 0.20 | |
| Water (%) | 2.3 | 3.54 | |
| Counter-ion (%) | not stated | 7.38 | |
| Peptide content (%w/w) | 92.9 | 88.24 | |
| Endotoxin (EU/mg) | 0.52 | 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, 3 d) → assay. Submitter did not handle the vial.
- Assay date
- 22 Jan 2026
- Submitted to the index
- 01 Feb 2026
- 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-2510-P7043 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043542 | BCH-2510-P7043 | Kestrel | 2026-Q1 | 99.20 | 3.08 | — | Supplier-supplied | 2 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042181 | Homopeptide | HOMO-2608-A9045 | Janoshik | 2026-Q3 | 99.78 | 4.79 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042180 | Homopeptide | HOMO-2608-A9045 | Janoshik | 2026-Q3 | 99.39 | 4.74 | 105.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042184 | Homopeptide | HOMO-2608-A9045 | Kestrel | 2026-Q3 | 99.27 | 4.79 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041427 | QYB | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 4.12 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042183 | Homopeptide | HOMO-2608-A9045 | VendorInvestigate | 2026-Q3 | 99.38 | 4.97 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043090 | KP | KP-2606-D5887 | Janoshik | 2026-Q3 | 98.18 | 3.07 | 101.2 | Laboratory-retained | 1 | FAIL |
| AX-2026-042191 | Homopeptide | HOMO-2608-A9045 | Medutest | 2026-Q3 | 99.67 | 5.00 | 104.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041425 | QYB | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 3.65 | 93.4 | 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 |