Ivacaftor Impurity 14 CAS 54535-22-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.54535-22-7
Molecular FormulaC14H17NO4
Molecular Weight263.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ivacaftor Impurity 14 CAS 54535-22-7 chemical structure

Description

CATO supplies Ivacaftor Impurity 14 (CAS 54535-22-7), a pharmacopoeial impurity reference standard (molecular formula C14H17NO4, MW 263.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ivacaftor Impurity 14 (C14H17NO4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 263.29 g/mol, it falls into the medium-molecular-weight range. 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), Ivacaftor Impurity 14 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 FormulaC14H17NO4
Molecular Weight263.29 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 methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Nitrogen Atoms1

Related Ivacaftor Standards

Recommended Standards

Why CATO?