Zolpidem Tartrate EP Impurity B CAS CATO-C4X-148618

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-148618
Molecular FormulaC19H20BrN3O
Molecular Weight386.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Zolpidem Tartrate EP Impurity B CAS CATO-C4X-148618 chemical structure

Description

Zolpidem Tartrate EP Impurity B (CAS CATO-C4X-148618) is a certified pharmaceutical impurity reference standard with the molecular formula C19H20BrN3O and a molecular weight of 386.29 g/mol.

Structurally, Zolpidem Tartrate EP Impurity B (C19H20BrN3O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 386.29 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC19H20BrN3O
Molecular Weight386.29 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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
Halogen ContentBr-containing
Nitrogen Atoms3

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