Trametinib impurity 12 CAS 3018911-27-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3018911-27-5
Molecular FormulaC17H17FIN3O3
Molecular Weight457.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trametinib impurity 12 CAS 3018911-27-5 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 Trametinib impurity 12.

CATO supplies Trametinib impurity 12 (CAS 3018911-27-5), a pharmacopoeial impurity reference standard (molecular formula C17H17FIN3O3, MW 457.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Trametinib impurity 12 (C17H17FIN3O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/iodine 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. 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.

As a certified reference material (CRM), Trametinib impurity 12 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 FormulaC17H17FIN3O3
Molecular Weight457.24 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2005
Halogen ContentF/I-containing
Nitrogen Atoms3

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