Ledipasvir Impurity 8 CAS CATO-C4X-33138

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-33138
Molecular FormulaC7H14O6S2
Molecular Weight258.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ledipasvir Impurity 8 CAS CATO-C4X-33138 chemical structure

Description

As a process- or degradation-related impurity, Ledipasvir Impurity 8 (CAS CATO-C4X-33138, C7H14O6S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ledipasvir Impurity 8 (C7H14O6S2) contains a carbohydrate-derived structure, a sulfone group. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions.

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 FormulaC7H14O6S2
Molecular Weight258.31 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
Sulfur Atoms2

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