Description

Iso-Gemfibrozil (Gemfibrozil Impurity) is a high-purity chemical reference standard, specifically a known impurity of the lipid-regulating pharmaceutical agent Gemfibrozil. This compound is critical for analytical method development, validation, and quality control in pharmaceutical research and manufacturing. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories to ensure the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of Iso-Gemfibrozil in Gemfibrozil API and related formulations.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical standard to develop, optimize, and validate chromatographic methods for impurity detection.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) and Quality Assurance (QA) Testing: Essential for routine batch release testing of Gemfibrozil to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Academic and Clinical Research: Supports metabolic and pharmacokinetic studies related to Gemfibrozil.

Basic Information

Product Name	Iso-Gemfibrozil (Gemfibrozil Impurity)
CAS No.	86837-66-3
Molecular Formula	C15H22O3
Molecular Weight	250.33 g/mol
Synonyms	5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic Acid; Gemfibrozil Impurity A; Gemfibrozil Related Compound A; 2,2-Dimethyl-5-(2,5-xylyloxy)valeric Acid; Iso-Gemfibrozil; Gemfibrozil Isomer; Gemfibrozil EP Impurity A
EINECS	Contact for details

Quality Control

Our Iso-Gemfibrozil is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, GC, NMR, and MS, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing purity, impurity profile, and analytical results. The product is suitable for use under ICH, USP, and EP guidelines for impurity standards.

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 prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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