Alectinib Impurity 63 CAS CATO-C4X-283663

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-283663
Molecular FormulaC30H35IN4O2
Molecular Weight610.53 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alectinib Impurity 63 CAS CATO-C4X-283663 chemical structure

Description

Alectinib Impurity 63 (C30H35IN4O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Alectinib Impurity 63 (CAS CATO-C4X-283663) is a certified pharmaceutical impurity reference standard with the molecular formula C30H35IN4O2 and a molecular weight of 610.53 g/mol.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC30H35IN4O2
Molecular Weight610.53 g/mol
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentI-containing
Nitrogen Atoms4

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