Fluocinolone Acetonide Impurity N1 CAS 6598-95-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.6598-95-4
Molecular FormulaC26H31FO7
Molecular Weight474.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluocinolone Acetonide Impurity N1 CAS 6598-95-4 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 Fluocinolone Acetonide Impurity N1.

Fluocinolone Acetonide Impurity N1 (CAS 6598-95-4) is a certified pharmaceutical impurity reference standard with the molecular formula C26H31FO7 and a molecular weight of 474.52 g/mol.

The molecular framework of Fluocinolone Acetonide Impurity N1 (C26H31FO7) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Fluocinolone Acetonide Impurity N1 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 FormulaC26H31FO7
Molecular Weight474.52 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Halogen ContentF-containing

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