Pitavastatin Impurity 130 CAS CATO-C4X-1037130

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1037130
Molecular FormulaC29H32FNO4
Molecular Weight477.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 130 CAS CATO-C4X-1037130 chemical structure

Description

The occurrence of Pitavastatin Impurity 130 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Pitavastatin Impurity 130 (CAS CATO-C4X-1037130), a pharmacopoeial impurity reference standard (molecular formula C29H32FNO4, MW 477.57 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pitavastatin Impurity 130 (C29H32FNO4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 14.0, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 477.57 g/mol, it falls into the moderately-high-molecular-weight range. 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.

CATO manufactures Pitavastatin Impurity 130 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC29H32FNO4
Molecular Weight477.57 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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