Dutasteride Impurity 4 CAS 328-93-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.328-93-8
Molecular FormulaC8H5F6N
Molecular Weight229.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dutasteride Impurity 4 CAS 328-93-8 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 229.12 g/mol gives Dutasteride Impurity 4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dutasteride Impurity 4 (CAS 328-93-8), a pharmacopoeial impurity reference standard (molecular formula C8H5F6N, MW 229.12 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Dutasteride Impurity 4 (C8H5F6N) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 Dutasteride Impurity 4 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 FormulaC8H5F6N
Molecular Weight229.12 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentF-containing
Nitrogen Atoms1

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