Description

Dabigatran Etexilate Impurity H is a high-purity reference standard critical for analytical research and development in the pharmaceutical industry. This compound is essential for the identification, qualification, and quantification of related substances during the manufacturing and quality control of the anticoagulant drug Dabigatran Etexilate. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance: Used for routine batch testing and impurity profiling of Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for the API.

Basic Information

Product Name	Dabigatran Etexilate Impurity H
CAS No.	1702936-92-2
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound H; Dabigatran Impurity H; BIBR 953 ZW Impurity H; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; Pradaxa Impurity H
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity H is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive 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 all test results against established specifications. Our quality standards align with ICH guidelines and support compliance in cGMP 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). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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