Megestrol Acetate EP Impurity L CAS 3050754-59-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3050754-59-8
Molecular FormulaC48H64O8
Molecular Weight769.02 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Megestrol Acetate EP Impurity L CAS 3050754-59-8 chemical structure

Description

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.

CATO supplies Megestrol Acetate EP Impurity L (CAS 3050754-59-8), a pharmacopoeial impurity reference standard (molecular formula C48H64O8, MW 769.02 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system, Megestrol Acetate EP Impurity L is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 769.02 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

Physical & Chemical Properties

Molecular FormulaC48H64O8
Molecular Weight769.02 g/mol
Purity97%+
StorageStore at room temperature, 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)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2005

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