Altrenogest impurity 16 CAS CATO-C4X-248316

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-248316
Molecular FormulaC20H24O4
Molecular Weight328.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Altrenogest impurity 16 CAS CATO-C4X-248316 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 Altrenogest impurity 16.

Altrenogest impurity 16 (CAS CATO-C4X-248316) is a certified pharmaceutical impurity reference standard with the molecular formula C20H24O4 and a molecular weight of 328.40 g/mol.

The molecular framework of Altrenogest impurity 16 (C20H24O4) is characterized by a flavonoid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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 FormulaC20H24O4
Molecular Weight328.40 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 chloroform, dichloromethane, ethyl acetate, DMSO
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

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