Description

Dabigatran Methyl Ester Impurity 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, a direct thrombin inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The product is supplied with comprehensive analytical documentation to support rigorous quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical system suitability component in HPLC, UPLC, and LC-MS methods to ensure accuracy and specificity.
• Stability Studies and Forced Degradation: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing in GMP manufacturing environments to confirm impurity levels are within specified limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the drug's behavior and related substances.

Basic Information

Item	Details
Product Name	Dabigatran Methyl Ester Impurity
CAS No.	1610758-17-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Methyl Ester Related Compound; Dabigatran Ester Impurity; Methyl 3-({2-[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]pyrimidin-5-yl}carbonyl)pyrazin-2-yl]amino}propanoate; BIBR 953 Methyl Ester Impurity; Dabigatran Etexilate Methyl Ester Impurity; Pradaxa Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Methyl Ester Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information to support 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 under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated opening of the primary container.

Specification

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

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