Description

Dabigatran Impurity 9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in drug development and production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Dabigatran Etexilate API and its formulations.
• Essential for pharmaceutical research and development, supporting stability studies and degradation pathway analysis.
• Critical component in analytical method development and validation (HPLC, LC-MS) to meet ICH guidelines.
• Used in quality control laboratories for batch release testing to ensure product purity and compliance with regulatory filings.
• Serves as a key material for regulatory submissions (e.g., to FDA, EMA) requiring impurity profiling.
• Supports academic and clinical research investigating the metabolism and pharmacokinetics of Dabigatran.

Basic Information

Product Name	Dabigatran Impurity 9
CAS No.	1408238-41-4
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound 9; Dabigatran Etexilate Impurity 9; 3-[[2-[[[4-[[(Hexyloxy)carbonyl]amino]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid; BIBR 953 Impurity; Pradaxa Impurity; BIBR 1048 Impurity; Ethyl Dabigatran Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 9 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures the material is suitable for its intended use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool place away from incompatible materials.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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