Description

Candesartan Cilexetil Impurity 17 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Candesartan Cilexetil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Candesartan Cilexetil API and its formulations.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: A critical component in routine QC testing to ensure API batches comply with stringent pharmacopeial limits (e.g., ICH Q3A/B, USP, EP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions during drug product shelf-life studies.
• Research & Development: Used in R&D to understand the synthesis pathway, degradation mechanisms, and to establish purification processes for the API.

Basic Information

Product Name	Candesartan Cilexetil Impurity 17
CAS No.	1265625-66-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Candesartan Cilexetil Related Compound 17; Candesartan Cilexetil EP Impurity 17; Candesartan Cilexetil USP Impurity 17; Candesartan Impurity 17; 1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester; 1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Candesartan Cilexetil Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as HPLC, NMR, and MS.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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