Dabigatran Impurity N1 CAS 1416446-45-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1416446-45-1
Molecular FormulaC33H39N7O5
Molecular Weight613.71 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity N1 CAS 1416446-45-1 chemical structure

Description

CATO manufactures Dabigatran Impurity N1 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.

Dabigatran Impurity N1 (CAS 1416446-45-1) is a certified pharmaceutical impurity reference standard with the molecular formula C33H39N7O5 and a molecular weight of 613.71 g/mol.

Dabigatran Impurity N1 (C33H39N7O5) contains a nitrogen-containing heterocyclic scaffold, 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.

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.

Physical & Chemical Properties

Molecular FormulaC33H39N7O5
Molecular Weight613.71 g/mol
Purity97%+
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
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Nitrogen Atoms7

Related Dabigatran Standards

Recommended Standards

Why CATO?