Lefamulinum Impurity 5 CAS CATO-C4X-30475

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-30475
Molecular FormulaC22H34O6
Molecular Weight394.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lefamulinum Impurity 5 CAS CATO-C4X-30475 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 Lefamulinum Impurity 5.

CATO supplies Lefamulinum Impurity 5 (CAS CATO-C4X-30475), a pharmacopoeial impurity reference standard (molecular formula C22H34O6, MW 394.50 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Lefamulinum Impurity 5 (C22H34O6) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC22H34O6
Molecular Weight394.50 g/mol
AppearanceOff-white to pale 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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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