Midazolam Impurity 16 CAS 59467-64-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.59467-64-0
Molecular FormulaC16H15ClFN3
Molecular Weight303.76 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Midazolam Impurity 16 CAS 59467-64-0 chemical structure

Description

CATO supplies Midazolam Impurity 16 (CAS 59467-64-0), a pharmacopoeial impurity reference standard (molecular formula C16H15ClFN3, MW 303.76 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Midazolam Impurity 16 (C16H15ClFN3) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 303.76 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC16H15ClFN3
Molecular Weight303.76 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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