AX-2025-020943
Ipamorelin · 2 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2503-J2830
- Report ID
- AX-2025-020943
- Compound
- Ipamorelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- CPC — Chinese Peptide Company Co., Ltd.
- Batch / lot
- CPC-2503-J2830
- Declared label claim
- 2mg
- Laboratory
- PeptideMeter
- Assay date
- 05 Jan 2025
- Submitted
- 08 Jan 2025
- Quarter
- 2025-Q1
- Submitter
- survodutide_mixup
- 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, 28 min gradient, 214 nm | 97.71 | % area | ≥ 99.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.29 | % area | ≤ 1.0 | FAIL |
| Largest single impurity | RP-HPLC — [D-Trp]-epimer | 1.23 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 84.90 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.96 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.47 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.049 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 102.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.50 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 8.01 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.59 | % | — | 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 cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.57 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 7.78 | min | 7.73 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.20 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 55,377 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 0.83 | — | 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 | 7.78 | 4,749,009 | 97.71 | — |
| 2 | [D-Trp]-epimer | 7.67 | 59,782 | 1.23 | 0.000 |
| 3 | oxidised Trp (+16 Da) | 7.46 | 29,162 | 0.60 | +15.995 |
| 4 | des-Lys (−128 Da) | 7.57 | 13,123 | 0.27 | -128.095 |
| 5 | Aib-deletion sequence (−85 Da) | 7.52 | 4,860 | 0.10 | -85.053 |
| 6 | C-terminal free acid (+1 Da) | 7.95 | 4,374 | 0.09 | +0.984 |
| 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 | 6.50 |
| Counter-ion (acetate) | ion chromatography | 8.01 |
| Residual solvent + inorganic residue | estimated | 0.59 |
| Total peptide content | by difference | 84.90 |
| 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) | 98.0 | 97.71 | divergence +0.11 pp vs batch median |
| Total impurities (% area) | 2.00 | 2.29 | |
| Largest single impurity (% area) | 0.80 | 1.23 | |
| Water (%) | not stated | 6.50 | |
| Counter-ion (%) | not stated | 8.01 | |
| Peptide content (%w/w) | 98.3 | 84.90 | |
| 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, 5 d) → assay. Submitter did not handle the vial.
- Assay date
- 05 Jan 2025
- Submitted to the index
- 08 Jan 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot CPC-2503-J2830 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020937 | CPC-2503-J2830 | Janoshik | 2025-Q1 | 98.07 | 6.78 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-020938 | CPC-2503-J2830 | Nordanalyt | 2025-Q1 | 97.94 | 6.33 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-020939 | CPC-2503-J2830 | Janoshik | 2025-Q1 | 97.86 | 6.79 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-020940 | CPC-2503-J2830 | PeptideMeter | 2025-Q1 | 97.51 | 6.33 | — | Buyer-sourced | 2 | FAIL |
| AX-2025-020941 | CPC-2503-J2830 | Janoshik | 2025-Q1 | 97.34 | 6.17 | 98.1 | Buyer-sourced | 2 | FAIL |
| AX-2025-020942 | CPC-2503-J2830 | Medutest | 2025-Q1 | 98.13 | 6.81 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-020944 | CPC-2503-J2830 | Janoshik | 2025-Q1 | 97.89 | 6.60 | 102.0 | Supplier-supplied | 2 | FAIL |
| AX-2025-020945 | CPC-2503-J2830 | Janoshik | 2025-Q1 | 98.68 | 7.09 | — | Supplier-supplied | 3 | FAIL |
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-2026-043368 | N-Acetyl Semax Amide | CPC-2602-D2941 | Medutest | 2026-Q3 | 98.79 | 6.05 | 102.1 | Supplier-supplied | 0 | PASS |
| AX-2026-043335 | Liraglutide | CPC-2602-G1978 | Janoshik | 2026-Q3 | 97.29 | 4.91 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-043283 | L-Carnosine | CPC-2603-G1651 | Medutest | 2026-Q3 | 98.10 | 10.12 | 91.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043365 | BPC-157 | CPC-2602-W2646 | Medutest | 2026-Q3 | 98.56 | 2.80 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043332 | Liraglutide | CPC-2602-G1978 | Janoshik | 2026-Q3 | 97.16 | 4.88 | 91.3 | Supplier-supplied | 1 | FAIL |
| AX-2026-043289 | L-Carnosine | CPC-2603-G1651 | Janoshik | 2026-Q3 | 98.01 | 10.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043287 | L-Carnosine | CPC-2603-G1651 | Janoshik | 2026-Q3 | 98.35 | 9.89 | 93.2 | Supplier-supplied | 2 | FAIL |
| AX-2026-043367 | N-Acetyl Semax Amide | CPC-2602-D2941 | Nordanalyt | 2026-Q3 | 99.39 | 6.16 | 92.4 | Supplier-supplied | 0 | PASS |