Description

Dabigatran Impurity CAS NO 2096992-14-0 is a high-purity chemical reference standard used for analytical and research purposes in pharmaceutical development. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Dabigatran Etexilate by serving as a benchmark in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control testing, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component in developing, optimizing, and validating chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in GMP environments to ensure drug substance and product meet predefined specifications.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study metabolic pathways, degradation mechanisms, and to synthesize related analogs.

Basic Information

Product Name	Dabigatran Impurity
CAS No.	2096992-14-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound; Dabigatran Etexilate Impurity; Dabigatran Process Impurity; 2096992-14-0; Dabigatran Specified Impurity; (3-{[(2-{[(4-Carbamimidoylphenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl) Ethylcarbamate Impurity; Ethyl (3-((2-((4-carbamimidoylphenylamino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propyl)carbamate Impurity
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, NMR, and MS. We adhere to relevant quality guidelines to support its use in regulatory filings and GMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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