Description

n-[4-Chloro-2-(Phenylamino)Phenyl]-n-Methylacetamide, also known as Clobazam Impurity, is a critical reference standard used in the pharmaceutical development and quality control of the anticonvulsant drug Clobazam. Its primary value lies in enabling precise identification, quantification, and control of this specific impurity, which is essential for ensuring drug safety, efficacy, and regulatory compliance. This high-purity compound is indispensable for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on API synthesis, method validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for the identification and quantification of the n-[4-Chloro-2-(Phenylamino)Phenyl]-n-Methylacetamide impurity in Clobazam Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate sensitive HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays for commercial Clobazam batches.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability studies of Clobazam.
• Process Chemistry & Optimization: Used by process chemists to identify the source of this impurity during API synthesis, aiding in the refinement of manufacturing processes to minimize its formation.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity acceptance criteria and demonstrate control strategies.

Basic Information

Product Name	n-[4-Chloro-2-(Phenylamino)Phenyl]-n-Methylacetamide (Clobazam Impurity)
CAS No.	75524-13-9
Molecular Formula	C15H15ClN2O
Molecular Weight	274.75 g/mol
Synonyms	Clobazam Impurity; Clobazam Related Compound; 1-(4-Chloro-2-(phenylamino)phenyl)-N-methylacetamide; N-Methyl-2-[4-chloro-2-(phenylamino)phenyl]acetamide; 2-(4-Chloro-2-anilinophenyl)-N-methylacetamide; ONO-1401 Impurity; Frisium Impurity
EINECS	Contact for details

Quality Control

Our n-[4-Chloro-2-(Phenylamino)Phenyl]-n-Methylacetamide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and precise control of related substances, to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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