Mirogabalin Impurity 57 TFA CAS CATO-C4X-292457

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-292457
Molecular FormulaC12H19NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 57 TFA CAS CATO-C4X-292457 chemical structure

Description

CATO manufactures Mirogabalin Impurity 57 TFA 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.

CATO supplies Mirogabalin Impurity 57 TFA (CAS CATO-C4X-292457), a pharmacopoeial impurity reference standard (molecular formula C12H19NO3C2HF3O2, MW 339.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Mirogabalin Impurity 57 TFA (C12H19NO3C2HF3O2) 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, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC12H19NO3 C2HF3O2
Molecular Weight339.31 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, 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; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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