Azelastine Impurity 46 CAS 109386-70-1

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.109386-70-1
Molecular FormulaC12H23NO4
Molecular Weight245.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine Impurity 46 CAS 109386-70-1 chemical structure

Description

Azelastine Impurity 46 (C12H23NO4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

CATO supplies Azelastine Impurity 46 (CAS 109386-70-1), a pharmacopoeial impurity reference standard (molecular formula C12H23NO4, MW 245.32 g/mol) used for the identification and quantification of trace impurities in APIs.

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.

CATO manufactures Azelastine Impurity 46 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC12H23NO4
Molecular Weight245.32 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1988
Nitrogen Atoms1

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