Loteprednol Impurity 10 CAS CATO-C4X-195710

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-195710
Molecular FormulaC47H66O14
Molecular Weight855.02 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Loteprednol Impurity 10 CAS CATO-C4X-195710 chemical structure

Description

Structurally, Loteprednol Impurity 10 (C47H66O14) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 15.0, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 855.02 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Loteprednol Impurity 10 (CAS CATO-C4X-195710) is a certified pharmaceutical impurity reference standard with the molecular formula C47H66O14 and a molecular weight of 855.02 g/mol.

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 FormulaC47H66O14
Molecular Weight855.02 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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