Description

Dabigatran Etexilate Impurity E is a structurally defined degradation product and synthetic intermediate critical for the quality control and regulatory validation of the anticoagulant drug dabigatran etexilate. It serves as an essential reference standard for method development, stability studies, and impurity profiling in pharmaceutical manufacturing and regulatory submissions. This high-purity chemical is indispensable for contract research organizations (CROs), active pharmaceutical ingredient (API) manufacturers, and quality control laboratories engaged in compliance with ICH Q3A(R2), Q5, and pharmacopoeial monographs. Dabigatran Etexilate Impurity E CAS NO 1415506-19-2 supports rigorous analytical assurance across global drug development pipelines.

Application

• HPLC and UPLC reference standard for identification and quantification of impurity E in dabigatran etexilate drug substance and products
• Stability-indicating method validation for ICH-guided forced degradation studies (hydrolysis, oxidation, photolysis)
• Calibration standard in LC-MS/MS assays for trace-level impurity monitoring during API batch release
• Reference material for pharmacopoeial compliance testing per USP-NF Dabigatran Etexilate monograph and EP 10.0
• Supporting documentation for FDA ANDA, EU MAA, and PMDA regulatory filings requiring impurity qualification data
• Use in genotoxic impurity risk assessment (ICH M7) due to structural alerts associated with its benzimidazole core
• Internal standard preparation for quantitative NMR (qNMR) purity determination
• Training and proficiency testing material for QC laboratory personnel in GMP environments

Basic Information

Product Name	Dabigatran Etexilate Impurity E
CAS No.	1415506-19-2
Molecular Formula	C₂₅H₂₆N₆O₄
Molecular Weight	474.52 g/mol
Synonyms	Dabigatran Etexilate Related Compound E; Dabigatran Impurity E; N-(2-{[4-(2-Pyridyl)-1H-benzimidazol-2-yl]carbamoyl}phenyl)ethanesulfonamide; DBE-IMP-E; Dabigatran Etexilate Degradant E; 2-((2-(4-(Pyridin-2-yl)-1H-benzo[d]imidazol-2-yl)carbamoyl)phenyl)ethanesulfonamide; Dabigatran Etexilate Impurity 1415506-19-2
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is tested per ICH Q2(R2) guidelines and meets specifications for identity (IR, HPLC retention time match), assay (≥98.5% by HPLC), related substances (single impurity ≤0.10%, total impurities ≤0.50%), residual solvents (per ICH Q3C), and heavy metals (≤10 ppm). Testing is performed in ISO/IEC 17025-accredited laboratories supporting GMP-compliant pharmaceutical supply chains.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent degradation. Due to hygroscopic nature, maintain low-humidity conditions (<30% RH) and minimize exposure to ambient air during handling.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard (±0.1 min)
Assay (by HPLC)	98.5% – 101.0%
Related Substances	Single impurity ≤0.10%; Total impurities ≤0.50%
Residual Solvents (by GC)	Meets ICH Q3C Class 3 limits
Water (by KF)	≤0.5%
Heavy Metals	≤10 ppm

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