Midazolam EP Impurity E Maleate Salt CAS CATO-C4X-150922

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-150922
Molecular FormulaC16H15ClFN3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Midazolam EP Impurity E Maleate Salt CAS CATO-C4X-150922 chemical structure

Description

Midazolam EP Impurity E Maleate Salt (CAS CATO-C4X-150922) is a certified pharmaceutical impurity reference standard with the molecular formula C16H15ClFN3C4H4O4 and a molecular weight of 419.84 g/mol.

The molecular framework of Midazolam EP Impurity E Maleate Salt (C16H15ClFN3C4H4O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 C4H4O4
Molecular Weight419.84 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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