Description

Phenytoin Related Compound B (50 Mg) (Al-Pha-((Aminocarbonyl)Amino)-α-Phenyl Ben-Zeneacetic Acid) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker for the anticonvulsant drug phenytoin, enabling precise analysis and ensuring drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in phenytoin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in compliance with ICH Q2(R1) and USP guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency meets pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of phenytoin.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in metabolic and pharmacokinetic studies to investigate the behavior of related substances.

Basic Information

Product Name	Phenytoin Related Compound B (50 Mg) (Al-Pha-((Aminocarbonyl)Amino)-α-Phenyl Ben-Zeneacetic Acid)
CAS No.	6802-95-5
Molecular Formula	C16H16N2O3
Molecular Weight	284.31 g/mol
Synonyms	α-[(Aminocarbonyl)amino]-α-phenylbenzeneacetic Acid; 5,5-Diphenylhydantoin Impurity B; Phenytoin Impurity B; 2-Phenyl-2-(phenylcarbamoylamino)acetic Acid; (RS)-2-Phenyl-2-[(phenylcarbamoyl)amino]acetic Acid; NSC 3298; Benzenepropanoic acid, α-[(aminocarbonyl)amino]-α-phenyl-
EINECS	Contact for details

Quality Control

Our Phenytoin Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric 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 impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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