Description

Dabigatran Etexilate Impurity 8 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 during manufacturing. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, API manufacturing, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance: Used in HPLC, LC-MS, and other chromatographic systems for the identification and quantification of this specific impurity in Dabigatran Etexilate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor impurity profiles in stability testing of Dabigatran Etexilate under various storage conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Dabigatran Etexilate to minimize the formation of this impurity.

Basic Information

Product Name	Dabigatran Etexilate Impurity 8
CAS No.	2225986-94-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Etexilate Related Compound 8; Dabigatran Impurity 8; Dabigatran Etexilate Process Impurity; BIBR 1048 Impurity; (3-{[(2-{[(4-{N'-[(Hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl)ethylcarbamate Impurity; Pradaxa Impurity 8
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity 8 is manufactured and handled under strict quality management systems. The material undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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