Description

Zopiclone Impurity B is a specified impurity and degradation product of the sedative-hypnotic drug Zopiclone. It is a critical reference standard used in pharmaceutical research, development, and quality control to ensure drug safety and efficacy. This high-purity compound is essential for analytical laboratories and manufacturers in the pharmaceutical industry for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Zopiclone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC, GC) for impurity profiling.
• Stability Studies & Forced Degradation: Employed as a marker to study the degradation pathways and shelf-life of Zopiclone under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) & Quality Assurance (QA): Serves as a system suitability and calibration standard in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to understand formation mechanisms and develop purer synthetic routes for Zopiclone API.

Basic Information

Product Name	Zopiclone Impurity B
CAS No.	1369509-04-5
Molecular Formula	C17H17ClN6O3
Molecular Weight	388.81 g/mol
Synonyms	6-(5-Chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5H-pyrrolo[3,4-b]pyrazin-5-one 4-Oxide; Zopiclone N-Oxide Impurity; Zopiclone EP Impurity B; Zopiclone Related Compound B; (5RS)-6-(5-Chloropyridin-2-yl)-7-oxo-5,6-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl N-oxide; UNII-6K3W155Q1P
EINECS	Contact for details

Quality Control

Our Zopiclone Impurity B is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results for purity, identity, and related substances. We support GMP/GLP-compliant applications and can supply materials suitable for use as in-house reference standards.

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 must be kept under inert conditions or in a desiccator after opening 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 unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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