Description

Telmisartan Impurity CAS NO 1098100-86-7 is a high-purity chemical 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 during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Telmisartan API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to comply with stringent pharmacopeial standards (USP, EP, ICH Q3A/B) for impurity limits.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Telmisartan products.
• Regulatory Submissions: Essential for preparing Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and synthesis process of Telmisartan.

Basic Information

Product Name	Telmisartan Impurity
CAS No.	1098100-86-7
Molecular Formula	C33H30N4O2
Molecular Weight	514.62 g/mol
Synonyms	Telmesartan Related Compound; Telmisartan EP Impurity; Telmisartan USP Impurity; 4'-[(1,7'-Dimethyl-2'-propyl[2,5'-bi-1H-benzimidazol]-1'-yl)methyl][1,1'-biphenyl]-2-carboxylic Acid; BIBR 277 Impurity; 1H,1'H-2,5'-Bibenzimidazole, 1,7'-dimethyl-2'-propyl-1'-[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-; Telmisartan Analog
EINECS	Contact for details

Quality Control

Our Telmisartan Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Production is aligned with ICH guidelines and relevant pharmacopeial requirements.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
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.