Description

Telmisartan Related Compound B (15 Mg) (4'-[(1,7'-Dimethyl-2'-Propyl-1H,1'H-2,5'-Bibenzo[D]Imidazol-1'-Yl)Methyl]Biphenyl-2-Carboxylic Acid) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound, with CAS NO 1026353-20-7, serves as a critical impurity marker in the development and validation of analytical methods for the antihypertensive drug Telmisartan. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Telmisartan Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control and Release Testing: Employed in routine QC laboratories to establish specification limits and ensure batch-to-batch consistency of Telmisartan products.
• Stability Studies: Used to track the formation of this related compound during forced degradation and long-term stability studies of Telmisartan.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Pharmacopoeial Testing: Supports compliance testing against monographs in USP, EP, and other international pharmacopoeias that specify limits for related substances.

Basic Information

Product Name	Telmisartan Related Compound B (15 Mg) (4'-[(1,7'-Dimethyl-2'-Propyl-1H,1'H-2,5'-Bibenzo[D]Imidazol-1'-Yl)Methyl]Biphenyl-2-Carboxylic Acid)
CAS No.	1026353-20-7
Molecular Formula	C33H30N4O2
Molecular Weight	514.62 g/mol
Synonyms	4'-[(1,7'-Dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl]biphenyl-2-carboxylic acid; Telmisartan Impurity B; Telmisartan Related Substance B; Telmisartan EP Impurity B; Telmisartan USP Related Compound B; BIBS 222; 1H,1'H-2,5'-Bibenzo[d]imidazole, 4'-[2-carboxy[1,1'-biphenyl]-4-yl]methyl]-1,7'-dimethyl-2'-propyl-
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured under strict quality control conditions. Every batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, assay, and impurity profiles. Our quality system is designed to support regulatory compliance for pharmaceutical applications, aligning with ICH and cGMP principles.

Storage

Preserve in the original, 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); ensure the container is kept sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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