Description

Dabigatran Impurity 19 is a high-purity reference standard used for the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Dabigatran Etexilate API and its formulated drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies & Degradation Pathway Analysis: Employed to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive identification and characterization data for specified impurities.
• Pharmacopoeial Testing: Used in testing to meet the requirements of pharmacopoeial monographs (e.g., USP, EP) for related substance analysis.
• Research on Impurity Synthesis & Characterization: Serves as a key intermediate or benchmark in synthetic chemistry research focused on impurity isolation and characterization.

Basic Information

Product Name	Dabigatran Impurity 19
CAS No.	1422435-38-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 19; Dabigatran Etexilate Impurity 19; BIBR 953 Impurity; 3-[[2-[[[4-(Hexyloxycarbonylamino-iminomethyl)phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]pyridin-2-ylamino]-propionic acid ethyl ester (proposed); 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 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with industry standards for reference materials. 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. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.