Midazolam EP Impurity E DiMaleate Salt CAS 59469-29-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.59469-29-3
Molecular FormulaC16H15ClFN3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Midazolam EP Impurity E DiMaleate Salt CAS 59469-29-3 chemical structure

Description

As a certified reference material (CRM), Midazolam EP Impurity E DiMaleate Salt 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.

Midazolam EP Impurity E DiMaleate Salt (CAS 59469-29-3) 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 DiMaleate 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. 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).

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.

Physical & Chemical Properties

Molecular FormulaC16H15ClFN3 2*C4H4O4
Molecular Weight419.84 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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
CAS Registry Year (est.)1973
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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