Description

Chlortalidone Impurity 13 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) Chlortalidone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Chlortalidone API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, validating, and verifying HPLC, UPLC, and GC analytical methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA, ICH) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of Chlortalidone products.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the impact and behavior of this impurity.
• Quality Assurance/Quality Control (QA/QC): Acts as a primary standard for routine batch release testing and in-house specification setting for impurity limits.

Basic Information

Item	Details
Product Name	Chlortalidone Impurity 13
CAS No.	856777-93-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Chlortalidone Related Compound 13; Chlortalidone EP Impurity C; Chlortalidone USP Impurity; 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; Chlortalidone Degradation Product; Chlortalidone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Chlortalidone Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS, IR) techniques to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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