Description

Telmisartan Impurity B CAS NO 1026438-56-1 is a specified impurity of the antihypertensive active pharmaceutical ingredient (API) Telmisartan, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Telmisartan-based drug products in compliance with stringent regulatory standards. It is primarily required by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Telmisartan Impurity B in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Essential for routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines in Telmisartan API and finished dosage forms.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity characterization data required for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and throughout product shelf-life.
• Research & Development: Used in R&D to study impurity formation pathways and to synthesize purer batches of the Telmisartan API.

Basic Information

Product Name	Telmisartan Impurity B
CAS No.	1026438-56-1
Molecular Formula	C33H30N4O2
Molecular Weight	514.62 g/mol
Synonyms	4'-[(1,7'-Dimethyl-2'-propyl[2,5'-bi-1H-benzimidazol]-1'-yl)methyl][1,1'-biphenyl]-2-carboxylic Acid; Telmisartan Impurity 2; Telmisartan Related Compound B; 1H,1'H-2,5'-Bibenzimidazole, 1,7'-dimethyl-2'-propyl-1'-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-; BIBR 277 Impurity; Telmisartan EP Impurity B
EINECS	Contact for details

Quality Control

Our Telmisartan Impurity B is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation by spectroscopic methods (IR, NMR, MS), and control of related substances. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to maintain stability and purity.

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)	Any 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.