Budesonide Impurity 01 CAS 1188271-73-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1188271-73-9
Molecular FormulaC21H26O6
Molecular Weight374.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Budesonide Impurity 01 CAS 1188271-73-9 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 Budesonide Impurity 01.

CATO supplies Budesonide Impurity 01 (CAS 1188271-73-9), a pharmacopoeial impurity reference standard (molecular formula C21H26O6, MW 374.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, a hydroxyl group, an ether linkage, Budesonide Impurity 01 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 374.43 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC21H26O6
Molecular Weight374.43 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989

Related Budesonide Standards

Recommended Standards

Why CATO?