Midazolam EP Impurity J CAS 59469-08-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.59469-08-8
Molecular FormulaC18H17ClFN3
Molecular Weight329.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Midazolam EP Impurity J CAS 59469-08-8 chemical structure

Description

CATO manufactures Midazolam EP Impurity J under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Midazolam EP Impurity J (CAS 59469-08-8), a pharmacopoeial impurity reference standard (molecular formula C18H17ClFN3, MW 329.80 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/chlorine substitution, Midazolam EP Impurity J is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 329.80 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

Physical & Chemical Properties

Molecular FormulaC18H17ClFN3
Molecular Weight329.80 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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