Description

Cinnarizine Impurity CAS NO 58972-17-1 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 manufacture of Cinnarizine, a widely used antihistamine and vasodilator. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and compliance with stringent global regulatory standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development, validation, and routine quality control testing of Cinnarizine active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling and Characterization: Used in analytical studies to identify and quantify this specific impurity, supporting the establishment of appropriate specification limits as per ICH Q3A and Q3B guidelines.
• Regulatory Submission and Compliance: Critical for preparing drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control to agencies like the FDA and EMA.
• Stability Studies: Employed as a marker to monitor impurity levels in Cinnarizine formulations under various stress conditions (e.g., heat, humidity, light) to determine shelf life.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways for Cinnarizine, aiming to minimize the formation of this impurity during manufacturing.
• Contract Research and Testing Laboratories: Essential for CROs and analytical service providers offering impurity testing and certification services to pharmaceutical clients.

Basic Information

Product Name	Cinnarizine Impurity
CAS No.	58972-17-1
Molecular Formula	C26H28N2
Molecular Weight	368.52 g/mol
Synonyms	1-(Diphenylmethyl)-4-(3-phenyl-2-propen-1-yl)piperazine; Cinnarizine Related Compound; Cinnarizine EP Impurity; Cinnarizine USP Impurity; (E)-1-Benzhydryl-4-(3-phenylallyl)piperazine; 1-Cinnamyl-4-(diphenylmethyl)piperazine; Cinnarizine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Cinnarizine Impurity (CAS 58972-17-1) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

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)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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