Description

Chlorthalidone Impurity F is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Chlorthalidone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Chlorthalidone Impurity F in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain accurate and precise.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) to establish product shelf life.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and potential impact.

Basic Information

Product Name	Chlorthalidone Impurity F
CAS No.	1796929-84-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Chlorthalidone Related Compound F; Chlorthalidone EP Impurity F; Chlorthalidone USP Impurity F; 2-Chloro-5-(1-hydroxy-3-oxo-2,3-dihydro-1H-isoindol-1-yl)benzenesulfonamide; 1-Oxo-1-(2-chloro-5-sulfamoylphenyl)isoindolin-3-ol; Chlorthalidone Degradation Product; Chlorthalidone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Chlorthalidone Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, MS, NMR) to ensure it meets the exacting standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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