Description

Dabigatran Etexilate Impurity C4 is a designated impurity standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API) Dabigatran Etexilate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and routine batch testing in the production of Dabigatran Etexilate and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Dabigatran Etexilate Impurity C4 in API and drug product testing.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC laboratories to confirm that impurity levels in commercial batches are within ICH Q3A/B regulatory limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of the drug substance and product.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Dabigatran Etexilate Impurity C4
CAS No.	1416446-43-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Etexilate Related Compound C4; Dabigatran Impurity C4; Dabigatran Etexilate EP Impurity C; Dabigatran Etexilate USP Impurity C4; Pradaxa Impurity C4; BIBR 1048 Impurity C4; Ethyl 3-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity C4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, LC-MS) 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 controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

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

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