Mirogabalin Impurity 201 CAS CATO-C4X-2924201

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2924201
Molecular FormulaC21H35N3O2
Molecular Weight361.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 201 CAS CATO-C4X-2924201 chemical structure

Description

The occurrence of Mirogabalin Impurity 201 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Mirogabalin Impurity 201 (CAS CATO-C4X-2924201, C21H35N3O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mirogabalin Impurity 201 (C21H35N3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Mirogabalin Impurity 201 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 FormulaC21H35N3O2
Molecular Weight361.52 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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