Description

Dabigatran Impurity 36 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for maintaining the stringent quality standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control (QC) and release testing of the anticoagulant drug Dabigatran Etexilate.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, response factors, and detection limits for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate thorough impurity identification and control strategies.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in drug substance and drug product under various storage conditions over time.
• Process Chemistry Research: Used by R&D scientists to study the formation pathways of this impurity during API synthesis and to optimize manufacturing processes for impurity minimization.
• Pharmacopoeial Testing: Supports testing in alignment with monographs from pharmacopoeias such as USP, EP, or JP that specify limits for known and unknown impurities.

Basic Information

Product Name	Dabigatran Impurity 36
CAS No.	265659-61-8
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound 36; BIBR 953 Impurity 36; 3-[[2-[[4-(Hexyloxycarbonylamino-iminomethyl)phenylamino]methyl]-1-methyl-1H-benzimidazole-5-carbonyl]-(pyridin-2-yl)amino]propionic acid ethyl ester; Ethyl 3-((2-((4-(((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propanoate
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 36 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR 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 each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an 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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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