Description

Dabigatran Impurity G is a high-purity chemical 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 routine quality control testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Dabigatran Etexilate API and its finished dosage forms.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH guidelines.
• Quality Control (QC) Testing: Employed as a system suitability and calibration standard in routine QC laboratories to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of drug products.
• Research & Development: Aids in synthetic chemistry research for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Dabigatran Impurity G
CAS No.	1912458-32-2
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Related Compound G; BIBR 953 ZW Impurity G; Ethyl 3-[[2-[[[4-[[(Hexyloxy)carbonyl]carbamimidoyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate; Dabigatran Etexilate Impurity G; BIBR 1048 MS Impurity G
EINECS	Contact for details

Quality Control

Our Dabigatran Impurity G is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

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 COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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