Description

Telmisartan Dimer Impurity CAS NO 884330-14-7 is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Telmisartan. This compound is essential for pharmaceutical manufacturers and analytical laboratories to accurately identify, quantify, and control this specific dimeric impurity during drug development and production. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance to ensure the safety, efficacy, and purity of antihypertensive medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments like HPLC and LC-MS in impurity profiling.
• Method Development and Validation: Used to develop, optimize, and validate chromatographic methods for the specific separation and detection of the Telmisartan dimer.
• Quality Control (QC) Testing: Employed in routine batch release testing of Telmisartan API to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization data.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions to establish product shelf-life.
• Research and Development: Aids in understanding the degradation pathways and synthesis by-products of Telmisartan.

Basic Information

Product Name	Telmisartan Dimer Impurity
CAS No.	884330-14-7
Molecular Formula	C₆₆H₆₈N₁₀O₈
Molecular Weight	1129.33 g/mol
Synonyms	1H-Benzimidazole-7-carboxylic acid, 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl][1,1'-biphenyl]-2-yl]methyl] ester; Telmisartan Dimer; Telmisartan Impurity Dimer; Bisartran Dimer Impurity; Telmisartan Related Compound Dimer; Dimer of Telmisartan; Telmisartan Dimeric Impurity
EINECS	Contact for details

Quality Control

Every batch of Telmisartan Dimer Impurity is manufactured and analyzed under strict quality management systems. It undergoes comprehensive testing using advanced techniques like HPLC, LC-MS, and NMR to confirm identity and ensure high purity, typically ≥95% (HPLC). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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