Description

Bifendate Impurity A is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Bifendate through precise impurity profiling. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The product is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bifendate Impurity A in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Serves as a system suitability standard and an external calibrant in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency.
• Stability Studies: Employed in forced degradation and long-term stability studies of Bifendate to track impurity formation pathways and establish shelf-life.
• Regulatory Submissions: Provides the necessary data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the properties and potential impact of this specific impurity.

Basic Information

Product Name	Bifendate Impurity A
CAS No.	1181519-47-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bifendate Related Compound A; Bifendate EP Impurity A; Bifendate USP Impurity A; Dimethyl 4,4'-Dimethoxy-5,6,5',6'-bis(methylenedioxy)biphenyl-2,2'-dicarboxylate Impurity; Biphenyldicarboxylate Impurity A; Bifendate Process Impurity; Bifendate Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Bifendate Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP, ChP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and storage conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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