Description

Dabigatran Etexilate Impurity R is a high-purity chemical reference standard, specifically identified as a process-related impurity of the anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during API synthesis and final drug product formulation. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in the development and manufacturing of novel oral anticoagulants (NOACs) to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Dabigatran Etexilate and related drug products.
• Method Development and Validation: Used in developing and validating robust analytical methods (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines and drug substance specifications.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity under various stress conditions and throughout shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the API's impurity profile.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Dabigatran Etexilate Impurity R
CAS No.	1610758-20-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Etexilate Related Compound R; Dabigatran Impurity R; BIBR 1048 Impurity R; (3-{[(2-{[(4-Carbamimidoylphenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl) ethyl carbonate; Ethyl 3-((2-((4-carbamimidoylphenylamino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propyl carbonate
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity R is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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