Betaxolol Impurity 7 CAS 91878-54-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.91878-54-5
Molecular FormulaC18H29NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Betaxolol Impurity 7 CAS 91878-54-5 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Betaxolol Impurity 7.

As a process- or degradation-related impurity, Betaxolol Impurity 7 (CAS 91878-54-5, C18H29NO3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Betaxolol Impurity 7 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 343.89 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

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 FormulaC18H29NO3 HCl
Molecular Weight343.89 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1983
Halogen ContentCl-containing
Nitrogen Atoms1

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