Description

Dabigatran Impurity 37 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the anticoagulant drug Dabigatran Etexilate. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting activities in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Dabigatran Etexilate and its related substances.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance: Used in routine QC testing of Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions and throughout product shelf-life studies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Dabigatran to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Dabigatran Impurity 37
CAS No.	211914-96-4
Molecular Formula	C20H22N6O3
Molecular Weight	394.43 g/mol
Synonyms	Dabigatran Related Compound 37; Dabigatran Etexilate Impurity 37; Ethyl 3-[[2-[[[4-[[(Hexyloxy)carbonyl]amino]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate; BIBR 953 Impurity; BIBR 1048 MS Impurity; (R)-Dabigatran Etexilate Impurity; Dabigatran Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 37 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including HPLC purity analysis, NMR and MS for structural confirmation, and determination of residual solvents and moisture content to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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