Description

Bifendate Impurity G is a high-purity chemical reference standard, a key impurity associated with the pharmaceutical compound Bifendate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and research. It is primarily used by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory affairs teams to ensure product safety, efficacy, and compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify, quantify, and monitor Bifendate Impurity G during drug substance and drug product development.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for purity and stability-indicating assays.
• Quality Control and Batch Release Testing: Essential for in-house QC testing to ensure active pharmaceutical ingredient (API) and finished product batches meet predefined impurity specifications.
• Stability Studies and Forced Degradation Testing: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity understanding and control as per ICH Q3A/B guidelines.
• Contract Research and Manufacturing (CRO/CMO): Used by service organizations to support client projects requiring precise impurity analysis and control strategy documentation.

Basic Information

Product Name	Bifendate Impurity G
CAS No.	79279-08-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bifendate Related Compound G; Bifendate EP Impurity G; Bifendate USP Impurity G; Bifendate Process Impurity G; Bifendate Degradation Product G; 4,4'-Dimethoxy-5,6,5',6'-bis(methylenedioxy)biphenyl-2,2'-dicarboxylic Acid Dipropyl Ester Impurity G; Biphenyldicarboxylate Impurity G
EINECS	Contact for details

Quality Control

Our Bifendate Impurity G is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.