Pitavastatin Impurity 6 CAS 172336-33-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.172336-33-3
Molecular FormulaC27H28FNO4
Molecular Weight449.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 6 CAS 172336-33-3 chemical structure

Description

As a process- or degradation-related impurity, Pitavastatin Impurity 6 (CAS 172336-33-3, C27H28FNO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Pitavastatin Impurity 6 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 449.51 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Pitavastatin Impurity 6 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC27H28FNO4
Molecular Weight449.51 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2006
Halogen ContentF-containing
Nitrogen Atoms1

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