Description

Cinepazide Impurity 5 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the pharmaceutical compound Cinepazide. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and development laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cinepazide active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions to establish product shelf life.
• Pharmacopoeial Testing: Supports testing to meet the standards set by pharmacopoeias such as USP, EP, and ChP.

Basic Information

Product Name	Cinepazide Impurity 5
CAS No.	1078-64-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(3,4,5-Trimethoxycinnamoyl)piperidine; Cinepazide Related Compound; Cinepazide EP Impurity; Cinepazide USP Impurity; Cinepazide Process Impurity; Cinnarizine Impurity (related); Piperidine, 1-[(E)-3-(3,4,5-trimethoxyphenyl)-2-propenoyl]-
EINECS	Contact for details

Quality Control

Our Cinepazide Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to ensure reliable and consistent material for your critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The material should be kept under an inert atmosphere if susceptible to oxidation and handled in a moisture-controlled environment if hygroscopic.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.