Crisaborole Impurity 43 CAS 58380-11-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.58380-11-3
Molecular FormulaC7H5BrO3
Molecular Weight217.02 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Crisaborole Impurity 43 CAS 58380-11-3 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 Crisaborole Impurity 43.

CATO supplies Crisaborole Impurity 43 (CAS 58380-11-3), a pharmacopoeial impurity reference standard (molecular formula C7H5BrO3, MW 217.02 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Crisaborole Impurity 43 (C7H5BrO3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Crisaborole Impurity 43 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 FormulaC7H5BrO3
Molecular Weight217.02 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Halogen ContentBr-containing

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