Description

Phenytoin Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Phenytoin, an anticonvulsant medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Phenytoin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Phenytoin batches to meet pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products in Phenytoin formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies and to understand the degradation pathways of Phenytoin.

Basic Information

Product Name	Phenytoin Impurity 3
CAS No.	1189192-83-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenytoin Related Compound 3; 5,5-Diphenylimidazolidine-2,4-dione Impurity 3; Phenytoin EP Impurity C; Phenytoin USP Related Compound 3; 1-Methyl-5,5-diphenylhydantoin (Tentative, verify structure); 3-Methyl-5,5-diphenylhydantoin (Tentative, verify structure); Phenytoin Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Phenytoin Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
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)	≤ 1.0% w/w

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