Description

Indapamide EP Impurity C is a specified impurity reference standard used in the quality control and analytical development of the antihypertensive drug Indapamide. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used for method validation, stability studies, and impurity profiling in accordance with pharmacopeial standards like the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Indapamide-related substances in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor and control impurity levels, ensuring compliance with EP, USP, and ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products in Indapamide formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and impurity profile of Indapamide.

Basic Information

Product Name	Indapamide EP Impurity C
CAS No.	77083-51-3
Molecular Formula	C16H16ClN3O3S
Molecular Weight	365.83 g/mol
Synonyms	4-Chloro-N-(2-methyl-1H-indol-1-yl)-3-sulfamoylbenzamide; 1-(4-Chloro-3-sulfamoylbenzamido)-2-methylindole; Indapamide Impurity C; Indapamide Related Compound C; Indapamide European Pharmacopoeia Impurity C; Indapamide EP Imp C
EINECS	Contact for details

Quality Control

Every batch of Indapamide EP Impurity C is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.