Description

Gemfibrozil Ep Impurity D is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Gemfibrozil. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Gemfibrozil API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure the final pharmaceutical product meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Gemfibrozil during synthesis and formulation processes.

Basic Information

Product Name	Gemfibrozil Ep Impurity D
CAS No.	1798429-95-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gemfibrozil Related Compound D; Gemfibrozil Impurity D; Gemfibrozil EP Impurity D; 5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic Acid Impurity; Gemfibrozil Process Impurity; Gemfibrozil Degradation Product; Gemfibrozil Specified Impurity
EINECS	Contact for details

Quality Control

Our Gemfibrozil Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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