Description

Dabigatran Impurity P is a high-purity 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 an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support your quality control and research needs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Dabigatran Etexilate API and its finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Used to track the formation of degradation products in Dabigatran formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Facilitates chemical and pharmacological research into the metabolism, degradation pathways, and synthesis of Dabigatran-related compounds.

Basic Information

Product Name	Dabigatran Impurity P
CAS No.	1408238-37-8
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	Dabigatran Related Compound P; BIBR 953 Impurity P; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate; Dabigatran Etexilate Impurity P; BIBR 1048 Impurity P; 1-Methyl-2-({4-[N-(hexyloxy)carbonyl]carbamimidoyl}phenyl)aminomethyl]benzimidazole-5-carboxylic Acid (Pyridin-2-yl)amide Propanoic Acid Ethyl Ester Derivative; Dabigatran Process Impurity P
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Impurity P is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial and industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability. Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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