Description

Telmisartan Impurity 7 is a designated impurity of the active pharmaceutical ingredient (API) Telmisartan, a widely prescribed angiotensin II receptor blocker. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, contract research organizations (CROs), and regulatory bodies to ensure the purity, safety, and efficacy of Telmisartan-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Telmisartan API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity).
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and toxicological profiles of Telmisartan-related substances.

Basic Information

Product Name	Telmisartan Impurity 7
CAS No.	17103-25-2
Molecular Formula	C33H30N4O2
Molecular Weight	514.62 g/mol
Synonyms	1,1'-Biphenyl]-2-carboxylic acid, 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-, methyl ester; Telmisartan Methyl Ester; Telmisartan Related Compound; Telmisartan Ester Impurity; Telmisartan Process Impurity; Telmisartan Degradant; 4'-[(1,4'-Dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl][1,1'-biphenyl]-2-carboxylic acid methyl ester
EINECS	Contact for details

Quality Control

Every batch of Telmisartan Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards. Comprehensive Certificates of Analysis (COA) detailing batch-specific results from HPLC, NMR, and MS are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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 individual impurity ≤ 0.5%
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.