Description

Dabigatran Etexilate Impurity I is a specified, structurally characterized impurity used in the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Dabigatran Etexilate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a vital reference standard for method development, validation, and routine batch analysis in the production of anticoagulant medications.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Dabigatran Etexilate API.
• Essential for analytical method development and validation (HPLC, LC-MS) in QC/QA laboratories.
• Used in stability studies and degradation pathway profiling of Dabigatran Etexilate drug substances and products.
• Critical for regulatory submissions (e.g., ANDA, NDA) to meet ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Supports process chemistry research and optimization to minimize impurity formation during API synthesis.
• Employed in pharmacopoeial testing to verify compliance with monograph specifications from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Dabigatran Etexilate Impurity I
CAS No.	255706-13-9
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound I; 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 ZW Impurity I; Pradaxa Impurity I; (R)-Dabigatran Etexilate Impurity I
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH, USP, and EP guidelines.

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 in a dry environment to prevent degradation. For long-term storage, consider storing under 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)	≥ 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.