Description

n-(5-Chloro-2-Pyridinyl)-2-Pyrazinecarboxamide (Zopiclone Impurity) is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of the active pharmaceutical ingredient Zopiclone, a widely prescribed non-benzodiazepine hypnotic. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require precise standards for method development, validation, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Zopiclone API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) by providing impurity characterization data.
• Stability Studies: Employed to monitor the formation of degradation products in Zopiclone under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study reaction pathways and optimize processes to minimize this specific impurity.

Basic Information

Product Name	n-(5-Chloro-2-Pyridinyl)-2-Pyrazinecarboxamide (Zopiclone Impurity)
CAS No.	349125-10-6
Molecular Formula	C10H7ClN4O
Molecular Weight	234.64 g/mol
Synonyms	Zopiclone Impurity; Zopiclone Related Compound; 2-Pyrazinecarboxamide, N-(5-chloro-2-pyridinyl)-; N-(5-Chloro-2-pyridinyl)pyrazine-2-carboxamide; 5-Chloro-2-pyrazinecarboxpyridinamide; Zopiclone Process Impurity; Zopiclone Degradant; UNII-9F8S6A6D4C
EINECS	Contact for details

Quality Control

Our n-(5-Chloro-2-Pyridinyl)-2-Pyrazinecarboxamide is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with cGMP and ICH guidelines.

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, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.