Description

Regadenoson Impurity 1 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 key reference standard for analytical method development and validation. It is primarily required by quality control laboratories, regulatory affairs departments, and R&D teams within the pharmaceutical and biotechnology industries to ensure drug purity, safety, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Regadenoson active pharmaceutical ingredient (API) and finished drug products.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies to monitor impurity profiles and degradation pathways of Regadenoson formulations.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and demonstrate control strategies.
• Supports research and development of Regadenoson synthesis processes and purification methodologies.
• Employed as a system suitability and calibration standard in pharmacopeial testing to ensure analytical instrument performance.

Basic Information

Product Name	Regadenoson Impurity 1
CAS No.	313348-29-7
Molecular Formula	C15H18N8O5
Molecular Weight	390.35 g/mol
Synonyms	1-[6-Amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]purin-2-yl]-N-methylpyrazole-4-carboxamide; Regadenoson Related Compound A; Regadenoson Degradant; Regadenoson Process Impurity; CVT-3146 Impurity; Adenosine A2A Receptor Agonist Impurity
EINECS	Contact for details

Quality Control

Our Regadenoson Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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