Description

Adefovir Impurity 30 is a designated impurity standard used in the analytical profiling and quality control of the antiviral drug Adefovir Dipivoxil. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Adefovir Dipivoxil API and its formulations.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of degradation products in Adefovir formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during process chemistry development.

Basic Information

Item	Details
Product Name	Adefovir Impurity 30
CAS No.	91240-66-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Adefovir Related Compound 30; Adefovir Dipivoxil Impurity 30; 9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine Impurity; PMEA Impurity; GS 840 Impurity
EINECS	Contact for details

Quality Control

Every batch of Adefovir Impurity 30 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Our quality commitment aligns with ICH guidelines. A detailed Certificate of Analysis (COA) containing batch-specific data 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider conditions of 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.