Haloperidol Impurity 38 HCl CAS 52669-92-8 (free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.52669-92-8 (free base)
Molecular FormulaC21H21ClFNO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Haloperidol Impurity 38 HCl CAS 52669-92-8 (free base) chemical structure

Description

As a process- or degradation-related impurity, Haloperidol Impurity 38 HCl (CAS 52669-92-8 (free base), C21H21ClFNOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Haloperidol Impurity 38 HCl (C21H21ClFNOHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC21H21ClFNO HCl
Molecular Weight394.31 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 chloroform, dichloromethane, ethyl acetate, DMSO
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
Halogen ContentF/Cl-containing
Nitrogen Atoms1

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