Clotrimazole Impurity 16 CAS 6922-89-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.6922-89-0
Molecular FormulaC19H15ClO
Molecular Weight294.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clotrimazole Impurity 16 CAS 6922-89-0 chemical structure

Description

As a process- or degradation-related impurity, Clotrimazole Impurity 16 (CAS 6922-89-0, C19H15ClO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, a hydroxyl group, an ether linkage, chlorine substitution, Clotrimazole Impurity 16 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 294.77 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 FormulaC19H15ClO
Molecular Weight294.77 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Halogen ContentCl-containing

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