Description

Diazepam Impurity E is a designated impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Diazepam. This compound is critical for ensuring the purity, safety, and efficacy of Diazepam formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Diazepam API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, GC) in compliance with ICH guidelines.
• Critical component in stability studies to monitor degradation pathways and establish shelf-life for Diazepam products.
• Used in quality control laboratories for system suitability testing and as a system precision check.
• Serves as a calibration standard to ensure the accuracy and precision of impurity profiling methods.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the FDA and EMA.
• Utilized in research and development for studying the metabolism and degradation chemistry of Diazepam.

Basic Information

Product Name	Diazepam Impurity E
CAS No.	20927-53-1
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; Desmethyldiazepam N-Oxide; Nordazepam N-Oxide; Diazepam N-Oxide Impurity; Diazepam Related Compound E; 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide
EINECS	Contact for details

Quality Control

Every batch of Diazepam Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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.