Description

Dabigatran Etexilate Impurity 1 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the anticoagulant drug Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and stability studies. Ensuring a reliable supply of this well-characterized impurity is essential for maintaining drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish drug shelf-life.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Chemical Research: Used in synthetic chemistry research to study the degradation pathways and metabolism of Dabigatran Etexilate.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing of Dabigatran Etexilate API.

Basic Information

Product Name	Dabigatran Etexilate Impurity 1
CAS No.	1610758-19-4
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound 1; BIBR 953 ZW Impurity; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; Dabigatran Etexilate Degradant; Pradaxa Impurity 1; BIBR 1048 Impurity; Dabigatran Etexilate Process Impurity
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assessment, residual solvent analysis, and structural confirmation (NMR, MS) to ensure identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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