Description

Dabigatran Impurity B is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Dabigatran Etexilate by accurately identifying and quantifying related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance. The use of this well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements and regulatory submissions.

Application

• Pharmaceutical Quality Control (QC): Primary use as a certified reference standard for the identification and quantification of impurities in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Regulatory Compliance and Documentation: Used to generate data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA, EMA, and other global health authorities to demonstrate product purity.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Dabigatran formulations under various stress conditions (e.g., heat, light, humidity).
• Pharmacopeial Testing: Essential for compliance testing against monographs in USP, EP, BP, or other international pharmacopeias that specify limits for related substances.
• Research and Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the API.
• Contract Research Organizations (CROs) and Testing Labs: Provides a reliable benchmark for third-party testing and batch release analysis for clients in the pharmaceutical supply chain.

Basic Information

Product Name	Dabigatran Impurity B
CAS No.	658078-29-6
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound B; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic Acid; BIBR 953 ZW Impurity B; Dabigatran Etexilate Impurity B; (R)-Dabigatran Impurity B; Pradaxa Impurity B
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant USP/EP requirements for pharmaceutical impurities.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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