Description

Dabigatran Impurity D is a high-purity reference standard of a key process-related impurity in the synthesis of the anticoagulant drug Dabigatran Etexilate. This compound is essential for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research institutions, quality control laboratories, and manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dabigatran Impurity D in Dabigatran Etexilate API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Enables precise impurity testing to ensure batch-to-batch consistency and compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and establish shelf-life specifications.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this specific impurity, improving yield and purity.

Basic Information

Product Name	Dabigatran Impurity D
CAS No.	1610758-22-9
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound D; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid; BIBR 953 Impurity D; BIBR 1048 Impurity D; Dabigatran Etexilate Impurity D; (R)-Dabigatran Impurity D; Ethyl Dabigatran Impurity
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.