Ritodrine impurity 5 CAS CATO-C4X-27435

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-27435
Molecular FormulaC8H15NO
Molecular Weight141.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ritodrine impurity 5 CAS CATO-C4X-27435 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ritodrine impurity 5.

CATO supplies Ritodrine impurity 5 (CAS CATO-C4X-27435), a pharmacopoeial impurity reference standard (molecular formula C8H15NO, MW 141.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Ritodrine impurity 5 (C8H15NO) contains an amide group, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; 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.

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 FormulaC8H15NO
Molecular Weight141.21 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
Nitrogen Atoms1

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