Description

Adefovir Dipivoxil Impurity 20 is a designated impurity standard used in the analytical profiling and quality control of the antiviral pharmaceutical, Adefovir Dipivoxil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams involved in the development and manufacturing of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Adefovir Dipivoxil Impurity 20 in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) protocols.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) during drug stability testing.
• Research and Development: Facilitates impurity profiling during process chemistry development and optimization to minimize its formation.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 20
CAS No.	323201-06-5
Molecular Formula	C20H32N5O8P
Molecular Weight	501.47 g/mol
Synonyms	9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine; PMEA Bis(POM); Adefovir Dipivoxil Related Compound 20; Bis(POM)PMEA; Adefovir Dipivoxil EP Impurity I; Adefovir Dipivoxil USP Related Compound; GS 0840 Impurity
EINECS	Contact for details

Quality Control

Our Adefovir Dipivoxil Impurity 20 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) are provided, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and pharmacopeial standards (USP, EP).

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. This material is hygroscopic (moisture-sensitive); 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 corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.