Amlodipine Impurity 26

CAS: 107812-86-2

Category: Pharmaceutical Intermediates

PurityAnalytical Reference Standard ≥98%; Pharmaceutical Research Grade ≥99%
Molecular FormulaC20H20Cl2N2O4
Molecular Weight423.29
AppearanceWhite to off-white crystalline powder or solid
Packaging1 g, 5 g, 10 g, 25 g amber glass bottles for analytical standards; 100 g or 500 g sealed containers for research and reference material supply
Testing IndicatorsAppearance — Visual inspection; Identification — HPLC retention time comparison and LC-MS analysis; Purity/Related substances — HPLC-UV or HPLC-DAD according to pharmaceutical impurity testing methods; Molecular structure confirmation — 1H NMR, 13C NMR and HRMS; Water content — Karl Fischer titration (ASTM E203); Residual solvents — GC analysis according to ICH Q3C guidelines; Melting point — Capillary melting point determination; Elemental analysis — CHN/halogen analysis.
Storage NotesStore in a cool, dry, well-ventilated area protected from light and moisture. Keep container tightly sealed. Recommended storage temperature is 2-8°C for long-term stability. Avoid exposure to strong acids, strong bases, and oxidizing agents.
Lead Time10 days
Amlodipine Impurity 26 is a related substance and process impurity of amlodipine, a calcium channel blocker pharmaceutical ingredient. It is mainly used as a reference standard, impurity marker, analytical reagent, and research material in pharmaceutical quality control, method development, impurity profiling, and stability studies of amlodipine and related dihydropyridine compounds.