Trifarotene Impurity 9 CAS 895542-08-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.895542-08-2
Molecular FormulaC31H37NO4
Molecular Weight487.63 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trifarotene Impurity 9 CAS 895542-08-2 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 Trifarotene Impurity 9.

As a process- or degradation-related impurity, Trifarotene Impurity 9 (CAS 895542-08-2, C31H37NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Trifarotene Impurity 9 (C31H37NO4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC31H37NO4
Molecular Weight487.63 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
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
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Nitrogen Atoms1

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