Description

Rp 48497 (Eszopiclone Impurity C) is a designated pharmaceutical impurity used as a certified reference standard in analytical chemistry. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Eszopiclone, a non-benzodiazepine hypnotic agent. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Eszopiclone Impurity C in drug substances and finished products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Eszopiclone.

Basic Information

Product Name	Rp 48497 (Eszopiclone Impurity C)
CAS No.	148891-53-6
Molecular Formula	C16H15ClN6O
Molecular Weight	342.78 g/mol
Synonyms	Eszopiclone Related Compound C; (S)-6-(5-Chloro-2-pyridinyl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methyl-1-piperazinecarboxylate; 5-[(4-Methyl-1-piperazinyl)carbonyl]-6-(5-chloro-2-pyridinyl)-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-7-one; Eszopiclone Impurity; Lunesta Impurity C; S-Zopiclone Impurity C
EINECS	Contact for details

Quality Control

Our Rp 48497 (Eszopiclone Impurity C) is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, NMR, and MS. We adhere to relevant pharmacopeial standards and ICH guidelines to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

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 unknown 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.