Description

Cinepazide Impurity 1 CAS NO 53792-97-5 is a specified impurity of the pharmaceutical compound Cinepazide, used as a critical reference standard in analytical chemistry. This compound is essential for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and regulatory bodies for method validation and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Cinepazide and its related substances.
• Method Development and Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure product consistency.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Cinepazide drug substances and products to identify potential degradation impurities.
• Research and Development: Used in synthetic chemistry and process research to understand impurity formation pathways and optimize purification processes.

Basic Information

Product Name	Cinepazide Impurity 1
CAS No.	53792-97-5
Molecular Formula	C20H27N3O5
Molecular Weight	389.45 g/mol
Synonyms	1-(4-Methoxybenzoyl)-4-(1-pyrrolidinylcarbonyl)piperazine; Cinepazide Related Compound A; Cinepazide EP Impurity A; Cinepazide USP Impurity; 4-(4-Methoxybenzoyl)-1-(pyrrolidine-1-carbonyl)piperazine; Cinepazide Impurity A; Cinepazide Specified Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Cinepazide Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmacopeial standards (such as USP and EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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)	Any individual impurity ≤ 1.0% 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.