AX-2026-042770
Ipamorelin · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2508-E9990
- Report ID
- AX-2026-042770
- Compound
- Ipamorelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2508-E9990
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 08 Feb 2026
- Submitted
- 22 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- r.kirchner
- 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 | 99.53 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.47 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 0.32 | % 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) | 711.3860 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.5 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.05 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.64 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.19 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.807 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 98.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.41 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.90 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.64 | % | — | 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 to pale-yellow 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 | 5.29 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 8.30 | min | 8.24 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.13 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 55,447 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs C-terminal free acid (+1 Da) | 1.25 | — | 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 | 8.30 | 4,837,467 | 99.53 | — |
| 2 | oxidised Trp (+16 Da) | 7.96 | 15,553 | 0.32 | +15.995 |
| 3 | des-Lys (−128 Da) | 8.08 | 3,402 | 0.07 | -128.095 |
| 4 | Aib-deletion sequence (−85 Da) | 8.02 | 1,944 | 0.04 | -85.053 |
| 5 | C-terminal free acid (+1 Da) | 8.48 | 1,944 | 0.04 | +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.
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 | 356.7003 | 0.0002 | 56.2 |
| 1+ | 712.3929 | 712.3933 | 0.0004 | 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 | 4.41 |
| Counter-ion (acetate) | ion chromatography | 6.90 |
| Residual solvent + inorganic residue | estimated | 0.64 |
| Total peptide content | by difference | 88.05 |
| 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) | 99.90 | 99.53 | divergence +0.16 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.47 | |
| Largest single impurity (% area) | 0.06 | 0.32 | |
| Water (%) | 4.2 | 4.41 | |
| Counter-ion (%) | not stated | 6.90 | |
| Peptide content (%w/w) | 91.0 | 88.05 | |
| 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, 3 d) → assay. Submitter did not handle the vial.
- Assay date
- 08 Feb 2026
- Submitted to the index
- 22 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 GGPE-2508-E9990 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042765 | GGPE-2508-E9990 | PeptideMeter | 2026-Q1 | 99.70 | 4.99 | 97.7 | Supplier-supplied | 0 | PASS |
| AX-2026-042766 | GGPE-2508-E9990 | Janoshik | 2026-Q1 | 99.93 | 5.26 | 104.7 | Supplier-supplied | 0 | PASS |
| AX-2026-042767 | GGPE-2508-E9990 | Janoshik | 2026-Q1 | 99.93 | 4.55 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042768 | GGPE-2508-E9990 | Janoshik | 2026-Q1 | 99.53 | 5.23 | 95.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042769 | GGPE-2508-E9990 | Janoshik | 2026-Q1 | 99.77 | 4.98 | — | Supplier-supplied | 1 | 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-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |