Description

Bifendate Impurity B is a high-purity 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 (DDB) through precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development, validation, and regulatory compliance. The compound is supplied with comprehensive analytical data to support your stringent quality requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Bifendate (DDB) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency according to ICH guidelines.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity samples for required impurity studies.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile and impact of related substances.

Basic Information

Product Name	Bifendate Impurity B
CAS No.	128142-41-6
Molecular Formula	C20H18O10
Molecular Weight	418.35 g/mol
Synonyms	DDB Impurity B; Bifendate Related Compound B; Dimethyl 4,4'-Dimethoxy-5,6,5',6'-bis(methylenedioxy)biphenyl-2,2'-dicarboxylate Impurity B; Schisandrin C Derivative Impurity; Biphenyldicarboxylate Impurity B; 5,5'-Dimethoxy-4,4',6,6'-bis(methylenedioxy)-[1,1'-biphenyl]-2,2'-dicarboxylic Acid Dimethyl Ester (Related Substance)
EINECS	Contact for details

Quality Control

Every batch of Bifendate Impurity B is manufactured and controlled under a strict quality management system. 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) detailing batch-specific results is provided with each shipment to support your quality and regulatory needs.

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. Keep the container sealed to protect the material from moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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