Description

Phenytoin Impurity 4 is a high-purity reference standard critical for pharmaceutical analysis and quality control. This compound is essential for the accurate identification, quantification, and monitoring of related substances in Phenytoin drug substances and finished products. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical industry. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of test methods in compliance with ICH guidelines.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and GC methods to identify and quantify Phenytoin Impurity 4 in active pharmaceutical ingredients (APIs) and formulations.
• Method Development and Validation: A critical component in developing and validating stability-indicating assay methods for Phenytoin and related products.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against specified limits as per pharmacopeial standards (USP, EP, BP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Supports synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Phenytoin Impurity 4
CAS No.	56079-91-5
Molecular Formula	C15H12N2O2
Molecular Weight	252.27 g/mol
Synonyms	5,5-Diphenyl-2,4-imidazolidinedione Impurity; Desmethyl Phenytoin; 5,5-Diphenylhydantoin Impurity 4; Norphenytoin; 5-(Phenyl)-5-phenylhydantoin; NSC 758842; 5,5-Diphenylimidazolidine-2,4-dione related compound; Phenytoin Related Compound 4
EINECS	Contact for details

Quality Control

Every batch of Phenytoin Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and Mass Spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The container should be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.