Description

Phenytoin Impurity 2 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in Phenytoin, a widely used antiepileptic drug. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in method development, stability studies, and regulatory compliance. Ensuring the integrity of your impurity profile is fundamental to drug safety and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Phenytoin and its formulations.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the level of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products.
• Stability Studies: Used to assess the formation of degradation products in Phenytoin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and qualification.
• Research and Development: Serves as a key intermediate or marker in synthetic chemistry and metabolic pathway studies related to Phenytoin.

Basic Information

Product Name	Phenytoin Impurity 2
CAS No.	36898-62-1
Molecular Formula	C15H12N2O2
Molecular Weight	252.27 g/mol
Synonyms	5,5-Diphenyl-2,4-imidazolidinedione Impurity 2; Desoxy Phenytoin; 5,5-Diphenylhydantoin Impurity B; 5,5-Diphenylimidazolidine-2,4-dione Related Compound; Phenytoin Related Compound B; 2,4-Imidazolidinedione, 5,5-diphenyl-; NSC 122063
EINECS	Contact for details

Quality Control

Every batch of Phenytoin Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against stringent in-house specifications. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopoeial standards for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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