Description

Dabigatran Etexilate Impurity G is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dabigatran Etexilate. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential component for method development, validation, and routine batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Dabigatran Etexilate API and its formulated drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity separation and detection.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing data for impurity identification, qualification, and establishing specification limits (ICH guidelines).
• Stability Studies: Employed as a marker to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of the API.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during API synthesis.
• Pharmacopoeial Testing: Serves as a system suitability and identification standard for testing according to pharmacopoeial monographs.

Basic Information

Item	Details
Product Name	Dabigatran Etexilate Impurity G
CAS No.	1643392-59-9
Molecular Formula	C34H41N7O5
Molecular Weight	627.73 g/mol
Synonyms	Dabigatran Etexilate Related Compound G; Dabigatran Etexilate EP Impurity G; Dabigatran Etexilate USP Impurity G; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; BIBR 953 Impurity G; Pradaxa Impurity G
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity G is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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