Description

Dabigatran Etexilate Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Dabigatran Etexilate. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurity profiles throughout the drug manufacturing process.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure product specifications are met.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate control strategies in accordance with ICH Q3A and Q3B guidelines.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Dabigatran Etexilate Impurity
CAS No.	1643377-48-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Etexilate Related Compound; Dabigatran Etexilate Process Impurity; Dabigatran Impurity; Pradaxa Impurity; BIBR 1048 Impurity; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate Impurity
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) and relevant ICH guidelines for impurities in new drug substances.

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 compound is hygroscopic (moisture-sensitive) and should be handled 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 solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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