Description

Telmisartan Ep Impurity 1 CAS NO 884330-11-4 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Telmisartan. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Telmisartan API.
• Method Development and Validation: Crucial for developing and validating robust HPLC, UPLC, or LC-MS analytical methods in R&D and QC laboratories.
• Stability Indicating Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Telmisartan formulations.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control & Batch Release: Enables precise impurity profiling to ensure every batch of Telmisartan API meets stringent pharmacopeial specifications (e.g., EP, USP).
• Academic and Contract Research: Serves as a key reagent in pharmaceutical chemistry research and for Contract Research Organizations (CROs) providing analytical services.

Basic Information

Product Name	Telmisartan Ep Impurity 1
CAS No.	884330-11-4
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 1; Telmisartan Related Compound 1; Telmisartan EP Impurity A; BIBR 277 Impurity; 2-(4-{[4-Methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}phenyl)benzoic Acid
EINECS	Contact for details

Quality Control

Every batch of Telmisartan Ep Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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