Description

Dabigatran Despropionyl Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Dabigatran Etexilate. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material for the identification and quantification of the despropionyl impurity in Dabigatran Etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Used in routine QC testing to ensure that impurity levels in commercial drug batches remain within specified safety thresholds.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, humidity, light) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize the formation of this specific impurity.

Basic Information

Product Name	Dabigatran Despropionyl Impurity
CAS No.	1015167-33-5
Molecular Formula	C21H25N7O3
Molecular Weight	423.47 g/mol
Synonyms	Dabigatran Impurity F; Dabigatran Related Compound F; BIBR 953 Despropionyl; 3-[[2-[[[4-[[(Hexylamino)carbonyl]amino]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic Acid; Dabigatran Etexilate Impurity F; Despropionyl Dabigatran; BIBR 1087 Despropionyl Impurity
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Despropionyl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to 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
Assay (on dried basis)	98.0% - 102.0%

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