Description

Diazepam Related Compound B (25 Mg) (3-Amino-6-Chloro-1-Methyl-4-Phenylcarbostyril) is a high-purity analytical reference standard, essential for pharmaceutical research and development. This compound serves as a critical impurity marker and analytical standard for ensuring the quality, safety, and efficacy of diazepam and related benzodiazepine-based active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development, validation, and regulatory compliance testing. Our product is supplied with comprehensive documentation to support your stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in diazepam drug substances and finished dosage forms, as per ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Stability Studies and Forced Degradation Testing: Employed to monitor and understand degradation pathways of diazepam under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Quality Control (QC) Laboratory Testing: Acts as a system suitability standard and a calibrant for routine batch release testing in pharmaceutical QC laboratories.
• Academic and Clinical Research: Supports pharmacological and metabolic studies related to benzodiazepines in academic and clinical research settings.

Basic Information

Product Name	Diazepam Related Compound B (25 Mg) (3-Amino-6-Chloro-1-Methyl-4-Phenylcarbostyril)
CAS No.	5220-02-0
Molecular Formula	C16H13ClN2O
Molecular Weight	284.74 g/mol
Synonyms	3-Amino-6-chloro-1-methyl-4-phenyl-2(1H)-quinolinone; 6-Chloro-1-methyl-4-phenyl-3-quinolinamine; Diazepam Impurity B; Diazepam Related Substance B; 3-Amino-6-chloro-1-methyl-4-phenylcarbostyril; 2H-3,1-Benzoxazine-2,4(1H)-dione, 3-amino-6-chloro-1-methyl-4-phenyl-; DBZ Impurity B; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Diazepam Related Compound B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH, USP, and EP guidelines for pharmaceutical reference standards.

Storage

Preserve in the original, 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); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%

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