Description

Chlorthalidone Impurity D CAS NO 1369995-36-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Chlorthalidone through rigorous impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and drug development.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Chlorthalidone Impurity D in drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Assurance: Used in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and adherence to strict pharmacopeial specifications (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Chlorthalidone to identify and characterize potential degradants.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and metabolic profiling of Chlorthalidone and related compounds.

Basic Information

Product Name	Chlorthalidone Impurity D
CAS No.	1369995-36-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Chlorthalidone Related Compound D; Chlorthalidone EP Impurity D; Chlorthalidone USP Impurity D; 5-Chloro-2-[(2,3-dihydro-1-hydroxy-3-oxo-1H-isoindol-1-yl)methyl]benzenesulfonamide (related compound); Chlorthalidone Specified Impurity D; Chlorthalidone Degradant D; Chlorthalidone Process Impurity D
EINECS	Contact for details

Quality Control

Our Chlorthalidone Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (e.g., by NMR and MS) to ensure identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with cGMP principles for pharmaceutical reference standards.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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