Fluvastatin Impurity 16 CAS 2117644-62-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2117644-62-7
Molecular FormulaC24H26FNO4
Molecular Weight411.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluvastatin Impurity 16 CAS 2117644-62-7 chemical structure

Description

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Fluvastatin Impurity 16 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 411.47 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).

Fluvastatin Impurity 16 (CAS 2117644-62-7) is a certified pharmaceutical impurity reference standard with the molecular formula C24H26FNO4 and a molecular weight of 411.47 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.

As a certified reference material (CRM), Fluvastatin Impurity 16 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 FormulaC24H26FNO4
Molecular Weight411.47 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentF-containing
Nitrogen Atoms1

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