Description

Dabigatran Impurity 11 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. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dabigatran Etexilate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure the final drug product meets pharmacopeial specifications (e.g., USP, EP) for impurity limits.
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various stress conditions (heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research & Development: Supports process chemistry research aimed at optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Dabigatran Impurity 11
CAS No.	1422495-93-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 11; Dabigatran Etexilate Impurity 11; BIBR 953 Impurity; Ethyl 3-[[2-[[4-(N'-hexylcarbamimidoyl)phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonylamino]propanoate; (R)-Ethyl 3-((2-((4-(N'-hexylcarbamimidoyl)phenylamino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carboxamido)propanoate
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards are designed to support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopeia requirements for pharmaceutical impurity standards.

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

Specification

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

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