Midazolam Impurity 41 CAS 59468-85-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.59468-85-8
Molecular FormulaC18H13ClFN3O
Molecular Weight341.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Midazolam Impurity 41 CAS 59468-85-8 chemical structure

Description

CATO supplies Midazolam Impurity 41 (CAS 59468-85-8), a pharmacopoeial impurity reference standard (molecular formula C18H13ClFN3O, MW 341.77 g/mol) used for the identification and quantification of trace impurities in APIs.

Midazolam Impurity 41 (C18H13ClFN3O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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), Midazolam Impurity 41 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 FormulaC18H13ClFN3O
Molecular Weight341.77 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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