Phenytoin Impurity 11 CAS 447-31-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.447-31-4
Molecular FormulaC14H11ClO
Molecular Weight230.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Phenytoin Impurity 11 CAS 447-31-4 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 Phenytoin Impurity 11.

As a process- or degradation-related impurity, Phenytoin Impurity 11 (CAS 447-31-4, C14H11ClO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system, Phenytoin Impurity 11 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 230.69 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

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 FormulaC14H11ClO
Molecular Weight230.69 g/mol
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentCl-containing

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