Pitavastatin Impurity 104 CAS CATO-C4X-1037104

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1037104
Molecular FormulaC9H16O5
Molecular Weight204.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 104 CAS CATO-C4X-1037104 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 Pitavastatin Impurity 104.

CATO supplies Pitavastatin Impurity 104 (CAS CATO-C4X-1037104), a pharmacopoeial impurity reference standard (molecular formula C9H16O5, MW 204.22 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C9H16O5, Pitavastatin Impurity 104 contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 204.22 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry.

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 FormulaC9H16O5
Molecular Weight204.22 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0

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