Description

Diazepam Impurity 2 CAS NO 102725-59-7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Diazepam. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the development and manufacturing of Diazepam API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to ensure Diazepam API and finished drug products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and levels of this impurity in Diazepam formulations under various stress conditions (e.g., heat, light, humidity) to determine shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and the safety of the drug substance.
• Research and Development: Facilitates studies on the degradation pathways and chemical behavior of Diazepam, aiding in process optimization and impurity mitigation strategies.

Basic Information

Product Name	Diazepam Impurity 2
CAS No.	102725-59-7
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 Impurity F; Diazepam N-Oxide; 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide; Ro 05-2921; Diazepam Related Compound F; 1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-5-phenyl-, 4-oxide
EINECS	Contact for details

Quality Control

Our Diazepam Impurity 2 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS). A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a 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 sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white 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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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