Description

Chlorthalidone Impurity G is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Chlorthalidone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for identifying and quantifying a specific process-related impurity during the development and routine testing of Chlorthalidone-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Chlorthalidone Impurity G in API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) and pharmacopoeial limits (USP, EP).
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Research and Development (R&D): Used in synthetic chemistry research to understand impurity formation pathways and to develop purer manufacturing processes for Chlorthalidone.

Basic Information

Product Name	Chlorthalidone Impurity G
CAS No.	16289-13-7
Molecular Formula	C14H11ClN2O4S
Molecular Weight	338.77 g/mol
Synonyms	4-Chloro-N-(2,3-dihydro-1-hydroxy-3-oxo-1H-isoindol-1-yl)-3-sulfamoylbenzamide; 1-Hydroxy-3-oxo-1-(4-chloro-3-sulfamoylbenzamido)isoindoline; Chlorthalidone EP Impurity G; Chlorthalidone Related Compound G; Chlorthalidone Sulfonamide Impurity; Benzamide, 4-chloro-N-(1,3-dihydro-1-hydroxy-3-oxo-1H-isoindol-1-yl)-3-sulfamoyl-
EINECS	Contact for details

Quality Control

Every batch of Chlorthalidone Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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