Description

Dabigatran Impurity 16 is a high-purity reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Dabigatran Etexilate. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and monitoring during the manufacturing process. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies focused on API synthesis, method validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of related substances in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure impurity levels in commercial batches are within specified safety limits.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Dabigatran.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., FDA, EMA) to support Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions.
• Process Chemistry Research: Used by synthetic chemists to study and control the formation of this specific impurity during the API synthesis and purification steps.

Basic Information

Product Name	Dabigatran Impurity 16
CAS No.	1848337-06-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Related Compound 16; Dabigatran Etexilate Impurity 16; BIBR 953 Impurity; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; Pradaxa Impurity 16; BIBR 1048 Impurity
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity 16 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
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)	≤ 2.0%

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