Description

Dabigatran Etexilate Impurity D is a high-purity reference standard used in 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 this specific impurity. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Dabigatran Etexilate Impurity D in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and purity.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Dabigatran Etexilate Impurity D
CAS No.	1422435-40-2
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound D; BIBR 953 ZW Impurity D; 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 EP Impurity D; Dabigatran Etexilate USP Impurity D; Pradaxa Impurity D
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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