Description

Dabigatran Impurity CAS NO 1117893-66-9 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the synthesis of the anticoagulant drug Dabigatran etexilate. It is primarily used by analytical chemists and quality control professionals in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity supports method validation and stability studies, directly impacting the quality of the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC laboratories.
• Impurity Profiling and Characterization: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify this specific impurity in Dabigatran etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: A critical component for developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies in line with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation over time and under various stress conditions.
• Process Chemistry Research: Aids synthetic chemists in optimizing manufacturing processes to minimize the formation of this impurity, improving yield and purity.

Basic Information

Item	Detail
Product Name	Dabigatran Impurity
CAS No.	1117893-66-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound; Dabigatran Etexilate Impurity; Dabigatran Process Impurity; (3-{[(2-{[(4-{N'-[(Hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl)phosphonic acid (putative); BIBR 953 Impurity; BIBR 1048 Impurity; Dabigatran Analog
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes rigorous testing using advanced chromatographic and spectroscopic techniques, including HPLC, NMR, and MS, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications. Our quality commitment supports your needs for reliable and consistent reference standards in GMP/GLP environments.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid repeated or prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C limits

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