Description

Dabigatran Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the anticoagulant drug Dabigatran Etexilate by accurately identifying and quantifying related substances. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology sectors. The product is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling and stability studies.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) requirements.
• Research & Development: Serves as a key reagent in pharmacokinetic, metabolic, and toxicological studies to understand the drug's impurity profile.

Basic Information

Product Name	Dabigatran Impurity F
CAS No.	1642853-67-5
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound F; Dabigatran Etexilate Impurity F; 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 F; 1-Methyl-2-(N-{4-[N-(hexyloxycarbonyl)amidino]phenyl}aminomethyl)benzimidazole-5-carboxylic Acid (2-Pyridyl) Amide Ethyl Ester; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed when not in use.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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