Description

Gemfibrozil Related Compound A, (E,Z)-2,2-Dimethyl-5-[2,5-Dimethyl-4-(Propene-1-Yl)Phenoxy]Valeric Acid is a high-purity chemical reference standard and a key process-related impurity in the synthesis of the lipid-regulating pharmaceutical agent, Gemfibrozil. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in active pharmaceutical ingredient (API) production and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantification and identification of related substances in Gemfibrozil API and finished dosage forms according to ICH guidelines.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling in pharmaceutical analysis.
• Quality Control & Assurance (QA/QC): Essential for routine batch release testing of Gemfibrozil to monitor and control process-related impurities, ensuring compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of Gemfibrozil under various environmental conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Process Chemistry Research: Used by synthetic chemists to study and optimize the Gemfibrozil synthesis pathway, aiming to minimize the formation of this specific impurity.

Basic Information

Product Name	Gemfibrozil Related Compound A ,(E,Z)-2,2-Dimethyl-5-[2,5-Dimethyl-4-(Propene-1-Yl)Phenoxy]Valeric Acid
CAS No.	500904-61-0
Molecular Formula	C19H28O3
Molecular Weight	304.43 g/mol
Synonyms	Gemfibrozil Impurity A; Gemfibrozil Related Substance A; 5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic Acid Isomer; (E,Z)-5-[4-(1-Propenyl)-2,5-dimethylphenoxy]-2,2-dimethylvaleric Acid; Gemfibrozil EP Impurity A; Gemfibrozil USP Related Compound A; 2,2-Dimethyl-5-(2,5-dimethyl-4-(prop-1-en-1-yl)phenoxy)pentanoic Acid
EINECS	Contact for details

Quality Control

Our Gemfibrozil Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and specific impurity profiling, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) are provided, detailing comprehensive test results against established specifications. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.