Description

Phenytoin Impurity 1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiepileptic drug Phenytoin by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of Phenytoin and its formulations.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Phenytoin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Used as a reference to track the formation of degradation products in Phenytoin under various stability-indicating conditions.
• Research & Development: Facilitates chemical and pharmacological research into the metabolism, degradation pathways, and synthesis of Phenytoin.

Basic Information

Product Name	Phenytoin Impurity 1
CAS No.	61693-07-0
Molecular Formula	C15H12N2O2
Molecular Weight	252.27 g/mol
Synonyms	5,5-Diphenyl-2,4-imidazolidinedione Impurity; 5,5-Diphenylhydantoin Impurity A; Phenytoin Related Compound A; 5,5-Diphenylimidazolidine-2,4-dione Impurity; Desylurea; NSC 407292; 2,4-Imidazolidinedione, 5,5-diphenyl-; 5,5-Diphenylhydantoin Degradant
EINECS	Contact for details

Quality Control

Every batch of Phenytoin Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment and is available upon request.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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