Description

Dabigatran Impurity K is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy 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 quality control testing.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Dabigatran Etexilate API and finished drug products.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Dabigatran.
• Serves as a critical material for regulatory compliance and filing (e.g., FDA, EMA) of generic and innovative drug applications.
• Supports research and development activities focused on impurity profiling and synthesis pathway optimization.
• Utilized in the calibration of analytical instruments to ensure accurate and reproducible results.

Basic Information

Product Name	Dabigatran Impurity K
CAS No.	2225986-95-6
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Related Compound K; Dabigatran Etexilate Impurity K; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid ethyl ester; BIBR 953 Impurity K; Ethyl 3-((2-((4-((((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propanoate
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity K is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH guidelines and supports regulatory submissions.

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 desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.