Description

Telmisartan Impurity 5 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Telmisartan through rigorous impurity profiling. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Telmisartan Impurity 5 in API and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Employed in routine batch release testing of Telmisartan to monitor and control impurity levels as per ICH Q3A/B guidelines.
• Stability Studies: Applied in forced degradation and long-term stability studies to track the formation of this specific impurity over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and toxicological profile of Telmisartan-related substances.

Basic Information

Product Name	Telmisartan Impurity 5
CAS No.	885046-20-8
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 Related Compound 5; Telmisartan Impurity B; Telmisartan EP Impurity B; Telmisartan USP Impurity 5; 1H,1'H-[2,5']Bibenzimidazolyl Derivative of Telmisartan
EINECS	Contact for details

Quality Control

Our Telmisartan Impurity 5 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail batch-specific results, ensuring compliance with pharmacopeial standards (USP, EP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

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)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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