Description

Regadenoson Impurity 10 is a specified impurity of the pharmaceutical agent Regadenoson, a coronary vasodilator used in cardiac stress imaging. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Regadenoson Impurity 10 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development: Serves as a critical component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels, ensuring they remain within International Council for Harmonisation (ICH) guidelines for drug substances.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Research & Development: Facilitates studies on the chemical behavior, formation pathways, and toxicological significance of this impurity during drug development.

Basic Information

Product Name	Regadenoson Impurity 10
CAS No.	2015222-31-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Regadenoson Related Compound 10; Regadenoson Specified Impurity 10; 2-[4-[(Methylamino)carbonyl]-1H-pyrazol-1-yl]adenosine Impurity; CVT-3146 Impurity 10; 1-{9-[(2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl}-N-methylpyrazole-4-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Regadenoson Impurity 10 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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