Description

Dabigatran Impurity 24 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 anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development and Validation in HPLC, UPLC, and LC-MS systems to establish impurity profiles.
• Quality Control (QC) and Quality Assurance (QA) testing in GMP-compliant pharmaceutical manufacturing facilities.
• Stability Studies to monitor the formation of degradation products under various stress conditions.
• Regulatory Submissions to agencies like the FDA and EMA, providing essential impurity characterization data.
• Research and Development for studying the metabolic pathways and degradation chemistry of Dabigatran.

Basic Information

Product Name	Dabigatran Impurity 24
CAS No.	2243727-83-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 24; Dabigatran Etexilate Impurity 24; 2243727-83-3; Dabigatran Process Impurity; Dabigatran Degradant; Dabigatran Specified Impurity
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity 24 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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