Description

Adenosine Impurity 7 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for the accurate identification and quantification of process-related impurities in Adenosine and its derivative drug substances. It is primarily used by research institutions, quality control laboratories, and pharmaceutical companies engaged in the development and production of nucleoside-based therapeutics, ensuring compliance with stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in quality control laboratories.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods for Adenosine and related API impurity profiling.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of specific degradants in Adenosine drug products under various stability conditions.
• Process Chemistry Research: Used by R&D scientists to study reaction pathways, optimize synthesis, and minimize impurity formation during API manufacturing.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify impurity controls for Adenosine.

Basic Information

Product Name	Adenosine Impurity 7
CAS No.	64570-12-3
Molecular Formula	C10H13N5O4
Molecular Weight	267.24 g/mol
Synonyms	6-Amino-9-β-D-ribofuranosyl-9H-purine; 6-Aminopurine riboside impurity; Adenosine related compound; 6-Aminopurine-9-β-D-ribofuranoside; 9-β-D-Ribofuranosyladenine; 6-Amino-9-β-D-ribofuranosylpurine; Adenine riboside; 6-Aminopurine nucleoside
EINECS	Contact for details

Quality Control

Every batch of Adenosine Impurity 7 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including identity confirmation by spectroscopic methods and purity determination by chromatographic techniques. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting batch-specific results for purity, impurities, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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