Description

Dabigatran Etexilate Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dabigatran Etexilate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing of anticoagulant medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dabigatran Etexilate API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in pharmaceutical R&D and QC laboratories.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability testing of drug substances and products.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Quality Control Testing: Serves as a system suitability and calibration standard in routine batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Process Chemistry Research: Used to study and control the formation of this impurity during the synthesis, purification, and scale-up processes of Dabigatran Etexilate manufacturing.

Basic Information

Product Name	Dabigatran Etexilate Impurity 4
CAS No.	1610758-21-8
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound 4; Dabigatran Impurity 4; Ethyl 3-[[2-[[[4-[[(Hexyloxy)carbonyl]carbamimidoyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate; BIBR 953 Impurity 4; Pradaxa Impurity 4; Dabigatran Etexilate EP Impurity D; Dabigatran Etexilate USP Impurity 4
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and impurity profile by validated chromatographic methods (HPLC). The quality standards are aligned with the requirements for pharmaceutical impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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