Description

Des-(n-2-Pyridyl-β-Alanine Ethyl Ester) Dabigatran Etexilate 5-Ethyl Carboxylate (Dabigatran Impurity) CAS NO 1408238-36-7 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists, quality assurance professionals, and regulatory affairs specialists working in pharmaceutical manufacturing and contract research organizations (CROs).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference standard for the identification and quantification of specific synthetic impurities during the development and manufacturing of Dabigatran Etexilate.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Dabigatran Etexilate drug substances and products.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure that drug substance and finished product batches meet stringent regulatory specifications for impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and long-term stability studies.
• Regulatory Submissions: Provides essential data and reference material for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Pharmacopoeial Testing: Supports testing to comply with monograph specifications in pharmacopoeias such as USP, EP, or JP where impurity limits are defined.

Basic Information

Product Name	Des-(n-2-Pyridyl-β-Alanine Ethyl Ester) Dabigatran Etexilate 5-Ethyl Carboxylate (Dabigatran Impurity)
CAS No.	1408238-36-7
Molecular Formula	C28H35N7O5
Molecular Weight	549.63 g/mol
Synonyms	Dabigatran Etexilate Impurity 5; Dabigatran Etexilate Related Compound 5; Dabigatran Impurity 5; 5-Ethyl Carboxylate Dabigatran Etexilate Impurity; BIBR 953 ZW Impurity; Ethyl 3-(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonylamino]propanoate; Pradaxa Impurity
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict GMP (Good Manufacturing Practice) conditions for non-pharmaceutical applications. Every batch undergoes rigorous analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is supplied with each lot, detailing the results for assay, purity, and specified impurities. Our quality system is designed to support regulatory compliance and ensure traceability and consistency for critical pharmaceutical development work.

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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%

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