Description

Diazepam Impurity 3 CAS NO 176796-46-6 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in Diazepam active pharmaceutical ingredient (API) and finished drug products. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of benzodiazepine-based medications. It is an essential material for analytical laboratories, R&D facilities, and manufacturers involved in the development, production, and quality assurance of Diazepam.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for method development and validation in HPLC, UPLC, and GC analysis.
• Quality Control and Release Testing: Used as a system suitability standard and for quantifying impurity levels in Diazepam API batches to meet ICH Q3A/B guidelines.
• Regulatory Submissions and Compliance: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings for FDA, EMA, and other global health authorities.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Pharmacopoeial Testing: Supports testing procedures aligned with USP, EP, BP, and other international pharmacopoeia monographs for Diazepam.
• Research and Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purer synthesis routes for Diazepam.

Basic Information

Product Name	Diazepam Impurity 3
CAS No.	176796-46-6
Molecular Formula	C₁₆H₁₃ClN₂O
Molecular Weight	284.74 g/mol
Synonyms	7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-Oxide; Diazepam N-Oxide; Diazepam Impurity D (EP); Diazepam Related Compound D (USP); 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide; Ro 05-2921; Diazepam N-Oxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Diazepam Impurity 3 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, GC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH 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 at 2-8°C. The material is light-sensitive (store away from light).

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
Heavy Metals	≤ 20 ppm

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