Description

Bifendate Impurity E CAS NO 205117-47-1 is a high-purity chemical reference standard, specifically identified as a process-related impurity of Bifendate (DDB), a hepatoprotective drug. This compound is critical for pharmaceutical research and development, serving as an essential benchmark for analytical method validation, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and quality assurance of Bifendate active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of Bifendate Impurity E in drug substance and drug product analysis.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency and safety.
• Regulatory Submissions: Essential for compiling Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and NMPA.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing protocols.
• Research and Development: Aids in process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Bifendate Impurity E
CAS No.	205117-47-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	DDB Impurity E; Bifendate Related Compound E; Dimethyl 4,4'-dimethoxy-5,6,5',6'-bis(methylenedioxy)biphenyl-2,2'-dicarboxylate Impurity E; Biphenyldicarboxylate Impurity E; (+/-)-Bifendate Impurity E; Schisandrin C Derivative Impurity; 205117-47-1; Bifendate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Bifendate Impurity E is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with the principles of cGMP and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material should be handled in accordance with good laboratory practices to maintain its stability and integrity as a reference standard.

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 unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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