Description

Dabigatran Impurity O is a specified impurity of the direct thrombin inhibitor, Dabigatran Etexilate. This compound is critical for analytical research and quality control processes in the pharmaceutical industry, ensuring the safety and efficacy of the final drug product. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Dabigatran Etexilate impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Assurance & Control (QA/QC): Used in routine batch analysis to ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3A/B guidelines) for related substances.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve the synthesis and purification processes of Dabigatran Etexilate.

Basic Information

Product Name	Dabigatran Impurity O
CAS No.	948551-71-1
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Related Compound O; Dabigatran Etexilate Impurity O; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid ethyl ester; BIBR 953 Impurity O; Ethyl 3-((2-((4-((((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propanoate
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Assay (HPLC)	95.0% - 105.0% on anhydrous basis
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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