Description

Telmisartan Ep Impurity B Methyl Ester CAS NO 1338830-37-7 is a high-purity chemical reference standard, specifically the methyl ester derivative of a key process-related impurity of the antihypertensive drug Telmisartan. This compound is critically important for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this impurity during API synthesis. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Telmisartan EP Impurity B in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control (QC) and Quality Assurance (QA): Used in routine QC testing to monitor impurity profiles and ensure Telmisartan API meets pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research and Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Telmisartan Ep Impurity B Methyl Ester
CAS No.	1338830-37-7
Molecular Formula	C34H30N4O3
Molecular Weight	542.63 g/mol
Synonyms	Methyl 4'-[(1,7'-Dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl]-[1,1'-biphenyl]-2-carboxylate; Telmisartan Methyl Ester Impurity; Telmisartan Related Compound B Methyl Ester; Telmisartan Process Impurity B Methyl Ester; 2'-Carbomethoxy-3'-methyl-4'-(2-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)benzimidazol-1-ylmethyl)biphenyl; BIBR-277-SE Methyl Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Telmisartan Ep Impurity B Methyl Ester is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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