Description

Adenosine Impurity 28 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing adenosine or its derivatives. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Adenosine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products in adenosine-based formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Facilitates metabolic and pharmacokinetic studies by helping to identify related substances in biological matrices.

Basic Information

Item	Details
Product Name	Adenosine Impurity 28
CAS No.	937802-78-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Adenosine Related Compound 28; Adenosine Impurity K; Adenosine Analog Impurity; 9H-Purin-6-amine, 9-β-D-ribofuranosyl- (specific isomer); Potential IUPAC name based on structure; Potential research code name; Contact for full list of synonyms.
EINECS	Contact for details

Quality Control

Our Adenosine Impurity 28 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Quality is verified using advanced techniques including HPLC and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles. Our quality system is designed to support compliance with ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Water Content (KF)	≤ 5.0%

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