AX-2025-021158
Ipamorelin · 2 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2505-U7155
- Report ID
- AX-2025-021158
- Compound
- Ipamorelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
- Batch / lot
- PPG-2505-U7155
- Declared label claim
- 2mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 24 Apr 2025
- Submitted
- 26 Apr 2025
- Quarter
- 2025-Q2
- Submitter
- ad.ibarra
- Sample provenance
- Buyer-sourced
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, 35 min gradient, 214 nm | 99.78 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.22 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — des-Lys (−128 Da) | 0.14 | % 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) | 711.3845 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -1.5 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.85 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.65 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.35 | 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 | 4.36 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.18 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.61 | % | — | 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 | 5.35 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 9.62 | min | 9.50 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.03 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 76,702 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 0.98 | — | 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 | 9.62 | 4,849,617 | 99.78 | — |
| 2 | des-Lys (−128 Da) | 9.36 | 6,804 | 0.14 | -128.095 |
| 3 | [D-Trp]-epimer | 9.48 | 1,944 | 0.04 | 0.000 |
| 4 | oxidised Trp (+16 Da) | 9.22 | 1,944 | 0.04 | +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 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 | 356.6995 | -0.0006 | 56.1 |
| 1+ | 712.3929 | 712.3918 | -0.0011 | 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 | 4.36 |
| Counter-ion (acetate) | ion chromatography | 5.18 |
| Residual solvent + inorganic residue | estimated | 0.61 |
| Total peptide content | by difference | 89.85 |
| 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) | 99.46 | 99.78 | divergence -0.28 pp vs batch median |
| Total impurities (% area) | 0.54 | 0.22 | |
| Largest single impurity (% area) | not stated | 0.14 | |
| Water (%) | not stated | 4.36 | |
| Counter-ion (%) | not stated | 5.18 | |
| Peptide content (%w/w) | not stated | 89.85 | |
| 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Domestic warehouse despatch → submitter (2–8 °C, 12 d) → laboratory (courier, cold pack, 11 d) → assay.
- Assay date
- 24 Apr 2025
- Submitted to the index
- 26 Apr 2025
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 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 PPG-2505-U7155 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021152 | PPG-2505-U7155 | Kestrel | 2025-Q2 | 99.93 | 4.60 | 103.9 | Buyer-sourced | 0 | PASS |
| AX-2025-021153 | PPG-2505-U7155 | Janoshik | 2025-Q2 | 99.66 | 4.85 | 89.3 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021154 | PPG-2505-U7155 | Janoshik | 2025-Q2 | 99.60 | 4.35 | 89.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021155 | PPG-2505-U7155 | Medutest | 2025-Q2 | 99.25 | 4.04 | 104.6 | Buyer-sourced | 0 | PASS |
| AX-2025-021156 | PPG-2505-U7155 | Janoshik | 2025-Q2 | 99.34 | 3.43 | 101.2 | Buyer-sourced | 0 | PASS |
| AX-2025-021157 | PPG-2505-U7155 | Janoshik | 2025-Q2 | 99.81 | 3.86 | 103.8 | Buyer-sourced | 0 | PASS |
| AX-2025-021159 | PPG-2505-U7155 | Kestrel | 2025-Q2 | 99.93 | 4.59 | — | Laboratory-retained | 0 | PASS |
| AX-2025-021160 | PPG-2505-U7155 | Medutest | 2025-Q2 | 99.87 | 4.45 | 97.2 | Buyer-sourced | 0 | PASS |
| AX-2025-021161 | PPG-2505-U7155 | Janoshik | 2025-Q2 | 99.70 | 4.55 | 92.9 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041377 | QYB | QYB-2605-H3558 | Nordanalyt | 2026-Q3 | 99.93 | 4.35 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041913 | SinoPep | SNP-2606-L4478 | PeptideMeter | 2026-Q3 | 98.88 | 5.28 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-041914 | SinoPep | SNP-2606-L4478 | Janoshik | 2026-Q3 | 99.14 | 5.49 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041909 | SinoPep | SNP-2606-L4478 | PeptideMeter | 2026-Q3 | 99.00 | 5.48 | 89.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041895 | SinoPep | SNP-2602-B3833 | Janoshik | 2026-Q3 | 99.93 | 4.72 | 105.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041898 | SinoPep | SNP-2602-B3833 | Nordanalyt | 2026-Q3 | 99.93 | 4.54 | 96.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041899 | SinoPep | SNP-2602-B3833 | PeptideMeter | 2026-Q3 | 99.93 | 4.96 | 90.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041891 | SinoPep | SNP-2602-B3833 | Janoshik | 2026-Q3 | 99.93 | 5.11 | — | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043598 | Tesamorelin | PPG-2608-A6835 | Kestrel | 2026-Q3 | 98.91 | 2.56 | 100.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043597 | Tesamorelin | PPG-2608-A6835 | Janoshik | 2026-Q3 | 98.54 | 1.15 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043596 | Tesamorelin | PPG-2608-A6835 | PeptideMeter | 2026-Q3 | 98.74 | 1.83 | 105.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043605 | Retatrutide | PPG-2604-X7060 | Janoshik | 2026-Q2 | 98.17 | 4.29 | 99.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043601 | Retatrutide | PPG-2604-X7060 | Janoshik | 2026-Q2 | 98.28 | 3.96 | 95.3 | Buyer-sourced | 0 | PASS |
| AX-2026-043668 | AOD-9604 | PPG-2602-W8018 | PeptideMeter | 2026-Q2 | 99.47 | 3.06 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043670 | AOD-9604 | PPG-2602-W8018 | PeptideMeter | 2026-Q2 | 99.56 | 2.71 | 104.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043630 | CJC-1295 (no DAC) | PPG-2512-D7211 | Janoshik | 2026-Q2 | 99.66 | 5.11 | 92.5 | Buyer-sourced | 0 | PASS |