Description

Regadenoson Impurity 5 is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for ensuring the safety and efficacy of the parent drug, Regadenoson, by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent global pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Regadenoson active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure drug substance and product purity meets ICH, USP, or EP specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Regadenoson Impurity 5
CAS No.	1627202-38-3
Molecular Formula	C15H18N8O5
Molecular Weight	390.35 g/mol
Synonyms	Regadenoson Related Compound 5; 2-[4-[(Methylamino)carbonyl]-1H-pyrazol-1-yl]adenosine Impurity; 1-{9-[(2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl}-N-methylpyrazole-4-carboxamide Impurity; Lexiscan Impurity 5; CVT-3146 Impurity 5; Adenosine A2A Receptor Agonist Impurity; 1H-Pyrazole-4-carboxamide, 1-[9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)-2-tetrahydrofuranyl]-6-amino-9H-purin-2-yl]-N-methyl-
EINECS	Contact for details

Quality Control

Our Regadenoson Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (NMR, MS), to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is supplied with every shipment, providing traceable data against customer specifications or in-house standards. Our quality commitment aligns with the requirements for reference standards used in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing desiccated under inert atmosphere.

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%
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.