Description

Adefovir Dipivoxyl Impuritiesb (Adefovir Dipivoxyl Dimer) is a critical reference standard and impurity used in the pharmaceutical development and quality control of Adefovir Dipivoxil, an antiviral medication. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and quality assurance of antiviral therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling and Control: Used to identify, monitor, and quantify the dimer impurity in Adefovir Dipivoxil active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and LC-MS, for impurity detection.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity levels for drug approval and pharmacopeial compliance (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Adefovir Dipivoxil.
• Process Chemistry Research: Used by R&D scientists to optimize synthesis and purification processes to minimize the formation of this specific dimer impurity.

Basic Information

Product Name	Adefovir Dipivoxyl Impuritiesb (Adefovir Dipivoxyl Dimer)
CAS No.	323201-05-4
Molecular Formula	C24H38N10O12P2
Molecular Weight	752.58 g/mol
Synonyms	Bis(POM)-PMEA Dimer; Adefovir Dipivoxil Dimer Impurity; Adefovir Dipivoxyl Dimer; 9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine Dimer; PMEA Dipivoxil Dimer; GS 840 Dipivoxil Dimer; Bis(POC)-PMEA Dimer; Adefovir Pivaloyloxymethyl Ester Dimer
EINECS	Contact for details

Quality Control

Our Adefovir Dipivoxyl Dimer is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (NMR, MS), and residual solvent analysis, to ensure identity, potency, and consistency. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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