Description

Regadenoson Impurity 3 is a specified impurity of the pharmaceutical agent Regadenoson, a coronary vasodilator used in cardiac stress imaging. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control of the active pharmaceutical ingredient (API). It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Regadenoson-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Regadenoson API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Regadenoson formulations under various storage conditions.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Regadenoson Impurity 3
CAS No.	1423073-21-5
Molecular Formula	C15H18N8O5
Molecular Weight	390.35 g/mol
Synonyms	Regadenoson Related Compound C; 2-[4-[(Methylamino)carbonyl]-1H-pyrazol-1-yl]adenosine Impurity; 1-[6-Amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]purin-2-yl]-N-methylpyrazole-4-carboxamide Impurity; Regadenoson EP Impurity C; Regadenoson USP Impurity; (2R,3R,4S,5R)-2-[6-Amino-2-[4-[(methylcarbamoyl)-1H-pyrazol-1-yl]purin-9-yl]-5-(hydroxymethyl)oxolane-3,4-diol Impurity
EINECS	Contact for details

Quality Control

Our Regadenoson Impurity 3 is manufactured under strict quality systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) containing batch-specific data on purity, impurities, and chromatographic profiles. 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, typically between 15-25°C (59-77°F). Keep the container in a dry environment to protect the hygroscopic material from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.