Description

Telmisartan Impurity 6 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Telmisartan during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories involved in the production of cardiovascular medications. The use of this well-characterized impurity standard is essential for meeting stringent regulatory requirements for drug approval and batch release.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Telmisartan API.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control & Assurance during the manufacturing process of Telmisartan to monitor impurity profiles.
• Regulatory Compliance and Filing, providing essential data for drug master files (DMFs) and submissions to agencies like the FDA and EMA.
• Stability Studies to track the formation of degradation products in Telmisartan formulations over time.
• Research and Development of synthetic pathways and purification processes for Telmisartan.

Basic Information

Product Name	Telmisartan Impurity 6
CAS No.	1083158-65-9
Molecular Formula	C33H30N4O2
Molecular Weight	514.62 g/mol
Synonyms	1H-Benzimidazole-7-carboxylic acid, 2-butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, methyl ester; Methyl 2-butyl-4-chloro-1-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate; Telmisartan Methyl Ester; Telmisartan Ester Impurity; Telmisartan Related Compound 6
EINECS	Contact for details

Quality Control

Every batch of Telmisartan Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic methods (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support regulatory needs with full traceability and documentation.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.