Description

Dabigatran Impurity 12 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.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Dabigatran Etexilate API and its formulations.
• Essential for pharmaceutical research and development (R&D), supporting the synthesis and purification process of the parent drug.
• Critical component in analytical method development and validation (e.g., HPLC, LC-MS) to meet ICH guidelines.
• Used in quality control (QC) and stability testing to monitor impurity levels throughout the drug product lifecycle.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Valuable for academic and pharmacological studies investigating the metabolism and degradation pathways of Dabigatran.

Basic Information

Product Name	Dabigatran Impurity 12
CAS No.	1422435-35-5
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound 12; Dabigatran Etexilate Impurity 12; Ethyl 3-[(2-{[(4-{N'-[(Hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; BIBR 953 Impurity; Pradaxa Impurity 12
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 12 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive analytical data, including HPLC purity, identity confirmation (IR, MS), and impurity profile, is provided. Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data are available upon request.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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