Description

Dabigatran Etexilate Impurity O is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Dabigatran Etexilate. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and monitoring during the manufacturing process. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies engaged in method validation, stability studies, and regulatory compliance for novel oral anticoagulants (NOACs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Used in developing and validating robust analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS), for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the levels of specified impurities in Dabigatran Etexilate batches to ensure they meet pharmacopeial limits (e.g., USP, EP).
• Stability Studies: A key component in forced degradation and long-term stability studies to identify and track impurity formation under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development: Used in synthetic chemistry R&D to study the formation pathways of this impurity and to develop optimized, impurity-controlled manufacturing processes.

Basic Information

Product Name	Dabigatran Etexilate Impurity O
CAS No.	1349500-09-9
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Related Compound O; BIBR 1048 Impurity O; Ethyl 3-[[2-[[[4-[[(hexyloxy)carbonyl]amino]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate; Dabigatran Etexilate Process Impurity; Pradaxa Impurity O; BIBR-953 Impurity; Dabigatran Etexilate Analog
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity O is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled 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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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