Description

Telmisartan Ep-J CAS NO 885045-90-9 is a high-purity pharmaceutical intermediate and reference standard, specifically conforming to the European Pharmacopoeia (EP) monograph for Telmisartan. This compound is critical for ensuring the quality, safety, and efficacy of the final active pharmaceutical ingredient (API) used in antihypertensive medications. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and R&D facilities involved in the development, quality control, and production of angiotensin II receptor blocker (ARB) therapies.

Application

• Pharmaceutical Reference Standard: Primary use as an impurity marker and system suitability standard for HPLC and other chromatographic methods in Telmisartan API quality control.
• Analytical Research: Used in method development, validation, and verification studies within quality control (QC) and quality assurance (QA) laboratories.
• Pharmaceutical Synthesis: Serves as a key intermediate or starting material in the controlled synthesis of Telmisartan API, ensuring process consistency.
• Regulatory Compliance: Supports drug master file (DMF) submissions and regulatory audits by providing an EP-certified benchmark for impurity profiling.
• Academic & Clinical Research: Utilized in pharmacokinetic, metabolic, and stability studies related to Telmisartan.

Basic Information

Product Name	Telmisartan Ep-J
CAS No.	885045-90-9
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 EP Impurity J; Telmisartan Impurity J; Telmisartan Related Compound J; BIBR 277 diacid impurity; BIBR-277 Impurity J
EINECS	Contact for details

Quality Control

Our Telmisartan Ep-J is manufactured and tested to meet the stringent requirements of the European Pharmacopoeia (EP) monograph. Every batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and specified impurity profiling via validated HPLC methods. A Certificate of Analysis (COA) detailing all test results against EP specifications is provided with each shipment to ensure full traceability and regulatory compliance for our global B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity 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
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Complies with EP limits
Single Unknown Impurity	≤ 0.10%
Total Impurities	≤ 0.50%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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