Description

Diazepam Impurity 1 is a specified impurity and degradation product of the benzodiazepine drug Diazepam. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control testing. It is essential for laboratories in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies to ensure the purity, safety, and efficacy of Diazepam-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Diazepam Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH guidelines.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Diazepam and to establish shelf-life and storage conditions.
• Quality Control & Batch Release: Essential for routine quality control testing in pharmaceutical manufacturing to ensure batches meet stringent purity specifications.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data required for drug approval.
• Pharmacopoeial Testing: Used in testing to comply with monographs in pharmacopoeias such as USP, EP, and BP, where control of specified impurities is mandated.

Basic Information

Product Name	Diazepam Impurity 1
CAS No.	36020-94-7
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 N-Oxide; Nordazepam Impurity; 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide; Diazepam Related Compound A; 1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-5-phenyl-, 4-oxide
EINECS	Contact for details

Quality Control

Every batch of Diazepam Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopoeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 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.