Description

Diazepam Impurity CAS NO 40913-83-5 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Diazepam. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and compliance testing.

Application

• As a pharmaceutical reference standard for the identification and quantification of impurities in Diazepam API and finished dosage forms.
• For analytical method development and validation (HPLC, GC, LC-MS) in quality control laboratories.
• In stability studies and forced degradation studies to monitor impurity profiles over time.
• As a critical component in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• For research and development of generic Diazepam formulations, ensuring bioequivalence and safety.
• Used by contract research organizations (CROs) and testing facilities offering compliance and batch release services.

Basic Information

Product Name	Diazepam Impurity
CAS No.	40913-83-5
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 (EP); Diazepam Related Compound F; 7-Chloro-2,3-dihydro-5-phenyl-1H-1,4-benzodiazepin-2-one 4-Oxide; Diazepam N-Oxide; Nordazepam Impurity; 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 CAS 40913-83-5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC and spectroscopic methods, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards (USP, EP).

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 minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

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: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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