Description

Zopiclone Impurity 1 Sodium Salt is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities in the manufacturing of the active pharmaceutical ingredient Zopiclone. It is primarily utilized by analytical laboratories and quality control departments within the pharmaceutical and contract research organization (CRO) sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Zopiclone Impurity 1 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Serves as a critical standard for developing and validating analytical methods, particularly HPLC and LC-MS, for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used as a marker to track the formation of degradation products in Zopiclone drug substance and finished product stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the manufacturing process and impurity specifications.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during synthesis.

Basic Information

Product Name	Zopiclone Impurity 1 Sodium Salt
CAS No.	864920-32-1
Molecular Formula	C17H16ClN6O3Na
Molecular Weight	422.80 g/mol
Synonyms	6-(5-Chloro-2-pyridinyl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-one sodium salt; Zopiclone Related Compound A Sodium Salt; Sodium 6-(5-chloropyridin-2-yl)-7-oxo-5,6-dihydro-5H-pyrrolo[3,4-b]pyrazine-5-carboxylate; Zopiclone EP Impurity A Sodium Salt; Zopiclone USP Impurity A Sodium Salt; Zopiclone Impurity A (Sodium Salt); UNII-9J8K3A8U4Q
EINECS	Contact for details

Quality Control

Our Zopiclone Impurity 1 Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. The product is suitable for use as a reference standard in compliance with ICH Q3A/B and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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