Description

Diazepam Impurity 10 is a specified 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 benzodiazepine-based pharmaceutical products through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Diazepam API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): A critical component in the quality control workflow to ensure compliance with pharmacopoeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Diazepam formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Used in R&D to study the degradation pathways and impurity profiles of benzodiazepine compounds.

Basic Information

Product Name	Diazepam Impurity 10
CAS No.	25759-97-1
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 Related Compound J; 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide; 1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-5-phenyl-, 4-oxide; Diazepam Impurity J
EINECS	Contact for details

Quality Control

Every batch of Diazepam Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with ICH guidelines and relevant pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, NMR, and mass spectrometry confirmation.

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, keep the material under inert atmosphere to prevent potential 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%
Single Maximum Unknown 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.