Description

Adenosine Impurity 1 CAS NO 49540-14-9 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and quantification of process-related impurities in adenosine-based active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis of adenosine and its derivatives.
• Quality Control & Assurance: Used as a system suitability standard and for routine batch testing in API manufacturing to monitor and control impurity levels.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to identify and track degradation products formed in adenosine formulations under various stress conditions.
• Research & Development: Aids in synthetic route optimization by identifying and quantifying synthetic intermediates or by-products.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international standards.

Basic Information

Product Name	Adenosine Impurity 1
CAS No.	49540-14-9
Molecular Formula	C10H13N5O4
Molecular Weight	267.24 g/mol
Synonyms	9-β-D-Ribofuranosyladenine Impurity; Adenosine Related Compound; 6-Aminopurine riboside impurity; 9-β-D-Ribofuranosyl-9H-purin-6-amine; Adenosine EP Impurity; Adenosine USP Related Compound; Adenosine Process Impurity; 6-Amino-9-β-D-ribofuranosyl-9H-purine
EINECS	Contact for details

Quality Control

Every batch of Adenosine Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%

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