Description

Dabigatran Impurity 38 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anticoagulant 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 Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Dabigatran Etexilate API and its finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products in stability testing of Dabigatran formulations under various environmental conditions.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports R&D efforts in process chemistry optimization to minimize the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Dabigatran Impurity 38
CAS No.	1416446-40-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 38; Dabigatran Etexilate Impurity 38; 1416446-40-6; Dabigatran Process Impurity; Dabigatran Specified Impurity; Dabigatran Degradation Product; Pradaxa Impurity 38
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity 38 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory needs.

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 material is hygroscopic (moisture-sensitive) and must 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)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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