Description

Dabigatran Etexilate Impurity S is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and analytical validation of the active pharmaceutical ingredient (API) Dabigatran Etexilate, an oral anticoagulant. It serves as a key impurity marker for manufacturers, contract research organizations (CROs), and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards. The CAS number for this material is 1415901-84-6.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity profiling data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used as a benchmark to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug products.
• Process Chemistry & Optimization: Assists API manufacturers in monitoring and controlling the formation of this impurity during synthesis, purification, and scale-up processes.
• Academic & Clinical Research: Enables studies on the metabolism, pharmacokinetics, and toxicological profile of Dabigatran-related compounds.

Basic Information

Item	Detail
Product Name	Dabigatran Etexilate Impurity S
CAS No.	1415901-84-6
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound S; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propionic Acid Ethyl Ester; BIBR 953 ZW Impurity S; Ethyl 3-((2-((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenylamino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propanoate
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity S is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including HPLC purity analysis, spectroscopic identification (NMR, IR, MS), and residual solvent analysis, to meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) detailing batch-specific results is provided with each shipment to ensure full traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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