Description

Dabigatran Impurity 8 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 Impurity Profiling and Characterization: Used as a certified reference material to identify, quantify, and monitor this specific impurity during the development and manufacturing of Dabigatran Etexilate.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing in pharmaceutical QC laboratories to confirm that impurity levels are within ICH (Q3A, Q3B) and pharmacopeial (USP, EP) guidelines.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions and Compliance: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity control strategies and product safety.
• Research and Development: Utilized in synthetic chemistry R&D to study formation pathways and develop purification processes to minimize this impurity.

Basic Information

Item	Detail
Product Name	Dabigatran Impurity 8
CAS No.	1408238-40-3
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound 8; Dabigatran Etexilate Impurity 8; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid; BIBR 953 Impurity 8; (R)-Dabigatran Impurity 8
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 8 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 they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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