Description

Chlortalidone Ep Impurity A is a high-purity reference standard specifically identified as a known impurity of the diuretic pharmaceutical agent Chlortalidone. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is primarily used by research scientists and quality assurance professionals in the pharmaceutical and analytical chemistry industries to ensure the purity, safety, and efficacy of Chlortalidone drug substances and products.

Application

• Primary use as a certified reference standard for the identification and quantification of Chlortalidone impurities.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control laboratories.
• Essential for pharmacopoeial testing to meet stringent EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH (International Council for Harmonisation) guidelines.
• Used in stability studies and forced degradation studies to profile impurity formation in Chlortalidone formulations.
• Serves as a key material in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of Chlortalidone generics and related chemical synthesis pathways.

Basic Information

Product Name	Chlortalidone Ep Impurity A
CAS No.	345930-32-7
Molecular Formula	C14H11ClN2O4S
Molecular Weight	338.76 g/mol
Synonyms	1-Oxo-1,3-dihydro-2H-isoindole-2-acetic acid, 4-chloro-3-sulfamoyl-; 2-[(4-Chloro-3-sulfamoylbenzoyl)amino]acetic acid; Chlortalidone Impurity A; Chlortalidone Related Compound A; Chlortalidone Acid Impurity; Chlortalidone Degradation Product; Chlortalidone EP Impurity A; Chlortalidone USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Chlortalidone Ep Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial monographs (EP, USP). Comprehensive characterization is performed using advanced analytical techniques (HPLC, GC-MS, NMR, IR). Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.