Description

Indapamide Impurity 11 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the antihypertensive drug Indapamide by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on pharmaceutical impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling and Identification: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify Indapamide Impurity 11 in active pharmaceutical ingredient (API) batches and finished drug products.
• Method Development and Validation: Serves as a critical component in developing and validating stability-indicating assay methods for Indapamide according to ICH guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to ensure drug substance and drug product purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used as a marker to monitor the formation of degradation products under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.

Basic Information

Product Name	Indapamide Impurity 11
CAS No.	1856658-28-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1H-Indole-2-carboxylic acid, 4-chloro-3-[[(2,3-dihydro-2-methyl-1H-indol-1-yl)carbonyl]amino]-, methyl ester; 4-Chloro-N-[(2-methyl-2,3-dihydro-1H-indol-1-yl)carbonyl]-1H-indole-2-carboxylic acid methyl ester; Indapamide Related Compound; Indapamide Impurity I; Indapamide EP Impurity I
EINECS	Contact for details

Quality Control

Our Indapamide Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic techniques for structural verification (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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