Description

Dabigatran Etexilate Impurity C5 is a high-purity 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 active pharmaceutical ingredient (API) by serving as a benchmark for identification and quantification during analysis. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for method validation and stability studies. The compound is supplied with the CAS registry number 1416446-45-1.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Dabigatran Etexilate Impurity C5 in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure drug substance and drug product batches meet stringent impurity limits as per ICH guidelines.
• Stability Studies & Forced Degradation Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Pharmacopoeial Testing: Supports testing to meet monograph requirements of standards like USP or EP where applicable.

Basic Information

Product Name	Dabigatran Etexilate Impurity C5
CAS No.	1416446-45-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran Etexilate Related Compound C5; Dabigatran Impurity C5; BIBR 953 ZW Impurity C5; Ethyl 3-[[2-[[[4-(N'-hexylcarbamimidoyl)phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate; Dabigatran Etexilate EP Impurity C; Dabigatran Etexilate USP Impurity C5
EINECS	Contact for details

Quality Control

Every batch of Dabigatran Etexilate Impurity C5 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere in a desiccator.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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