Description

4'-(Dibromomethyl)-[1,1'-Biphenyl]-2-Carboxylic Acid (Telmisartan Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a key impurity in the synthesis and analysis of Telmisartan, an important angiotensin II receptor antagonist (ARB) used to treat hypertension. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug purity, safety, and regulatory compliance. The availability of this well-characterized impurity standard supports method development, validation, and stability studies for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Telmisartan API and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods in pharmaceutical quality control laboratories.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Telmisartan under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Employed in synthetic route development and optimization to understand and minimize impurity formation during Telmisartan manufacturing.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity profiling data.
• Academic & Contract Research: Serves as a research tool in universities and CROs (Contract Research Organizations) studying ARB pharmacology and synthetic chemistry.

Basic Information

Item	Details
Product Name	4'-(Dibromomethyl)-[1,1'-Biphenyl]-2-Carboxylic Acid (Telmisartan Impurity)
CAS No.	1797894-62-2
Molecular Formula	C15H10Br2O2
Molecular Weight	382.05 g/mol
Synonyms	2'-(Dibromomethyl)biphenyl-2-carboxylic acid; 4'-(Dibromomethyl)-2-biphenylcarboxylic Acid; Telmisartan Dibromomethyl Impurity; Telmisartan Impurity 1; Telmisartan Related Compound; BIBR 277 Impurity; Biphenyl-2-carboxylic acid, 4'-(dibromomethyl)-; 2-Carboxy-4'-(dibromomethyl)biphenyl
EINECS	Contact for details

Quality Control

Every batch of 4'-(Dibromomethyl)-[1,1'-Biphenyl]-2-Carboxylic Acid is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency meet the exacting standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for impurities in new drug substances and products.

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 compound is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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