Rotigotine Impurity 35 CAS CATO-C4X-192735

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-192735
Molecular FormulaC13H18N2O2
Molecular Weight234.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rotigotine Impurity 35 CAS CATO-C4X-192735 chemical structure

Description

CATO supplies Rotigotine Impurity 35 (CAS CATO-C4X-192735), a pharmacopoeial impurity reference standard (molecular formula C13H18N2O2, MW 234.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Rotigotine Impurity 35 (C13H18N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 Rotigotine Impurity 35 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 FormulaC13H18N2O2
Molecular Weight234.29 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
StorageStore at 2-8°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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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