Description

Indapamide Impurity F is a specified impurity used in the quality control and analytical research of the active pharmaceutical ingredient Indapamide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent regulatory standards. It serves as a key reference standard for method development, validation, and routine testing in the production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Indapamide API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity profiles.
• Stability Studies: Used to monitor impurity formation and degradation pathways in stability testing of pharmaceutical products.
• Pharmacopoeial Testing: Aids in compliance testing against pharmacopoeial monographs (USP, EP, BP).
• Research & Development: Utilized in synthetic chemistry R&D for route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Indapamide Impurity F
CAS No.	62574-66-7
Molecular Formula	C16H16ClN3O3S
Molecular Weight	365.83 g/mol
Synonyms	4-Chloro-N-(2-methyl-1H-indol-1-yl)-3-sulfamoylbenzamide; 4-Chloro-3-sulfamoyl-N-(2-methylindol-1-yl)benzamide; 1-(4-Chloro-3-sulfamoylbenzoyl)-2-methylindole; Indapamide Related Compound F; Indapamide Impurity 6; Indapamide EP Impurity F; Indapamide USP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Indapamide Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced chromatographic techniques. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to meet specific pharmacopoeial (USP/EP) or internal specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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