Description

Cinepazide Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the drug substance Cinepazide. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require reliable impurity standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use 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 & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Cinepazide Impurity 3
CAS No.	1352050-81-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[4-(3,4,5-Trimethoxycinnamoyl)piperazin-1-yl]propan-2-one; Cinepazide Related Compound 3; Cinepazide EP Impurity C; Cinepazide USP Impurity; Cinepazide Process Impurity; Cinnamoylpiperazine derivative impurity of Cinepazide
EINECS	Contact for details

Quality Control

Every batch of Cinepazide Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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