Description

Dabigatran Impurity E is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Dabigatran Etexilate API and its finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to accurately quantify impurities in drug substances and products.
• Stability Studies: Employed to monitor the formation and level of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Dabigatran.
• Pharmacopoeial Testing: Used in testing to comply with monograph specifications set by pharmacopoeias such as USP or EP.

Basic Information

Product Name	Dabigatran Impurity E
CAS No.	1456889-80-7
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound E; 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 E; Dabigatran Etexilate Impurity E; Dabigatran EP Impurity E; Dabigatran USP Impurity E; 1-Methyl-2-{N-[4-(N'-hexyloxycarbonylamidino)phenyl]aminomethyl}benzimidazole-5-carboxylic Acid (2-Pyridyl)amide Ethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with in-house specifications and relevant pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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% w/w

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