Leflunomide EP Impurity B (Teriflunomide) CAS 163451-81-8

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.163451-81-8
Molecular FormulaC12H9F3N2O2
Molecular Weight270.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Leflunomide EP Impurity B (Teriflunomide) CAS 163451-81-8 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 Leflunomide EP Impurity B (Teriflunomide).

As a process- or degradation-related impurity, Leflunomide EP Impurity B (Teriflunomide) (CAS 163451-81-8, C12H9F3N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Leflunomide EP Impurity B (Teriflunomide) (C12H9F3N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Leflunomide EP Impurity B (Teriflunomide) 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 FormulaC12H9F3N2O2
Molecular Weight270.21 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>90%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2003
Halogen ContentF-containing
Nitrogen Atoms2

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