Description

Dabigatran Impurity 14 is a high-purity reference standard of a specified process-related impurity used in the synthesis of the anticoagulant drug Dabigatran Etexilate. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, stability studies, and quality control to ensure drug safety and efficacy. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the production and validation of Dabigatran-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Stability Indicating Studies: Used in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Assurance (QC/QA): A critical component in the in-process control and batch release testing within GMP manufacturing environments to ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity understanding and control.
• Research and Development: Used in synthetic chemistry research to study reaction pathways and to develop improved purification processes for the API.

Basic Information

Product Name	Dabigatran Impurity 14
CAS No.	1422435-39-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 14; Dabigatran Etexilate Impurity 14; Dabigatran Process Impurity 14; (3-{[(2-{[(4-{N'-[(Hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl) 2-Amino-3-{[(hexyloxy)carbonyl]amino}propanoate; BIBR 953 Impurity; Pradaxa Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity 14 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality commitment aligns with ICH Q3A, Q3B, and Q6A guidelines. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry environment. For long-term storage, consider storing desiccated under inert atmosphere. The product is hygroscopic (moisture-sensitive).

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single 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.