Description

Adefovir Dipivoxil Impurity E is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the development and manufacturing of the antiviral drug Adefovir Dipivoxil. It is primarily used by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and contract research organization (CRO) sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Adefovir Dipivoxil active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (e.g., HPLC, UPLC) for the precise separation and detection of related substances.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity profiling and qualification data.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of drug substances and products under various ICH conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity during API manufacturing.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for related compounds.

Basic Information

Item	Details
Product Name	Adefovir Dipivoxil Impurity E
CAS No.	116384-54-4
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 E; Bis(POM)PMEA; Adefovir Pivaloyloxymethyl Ester Impurity E; GS 0840 Impurity E; 9-(2-Phosphonylmethoxyethyl)adenine Bis(pivaloyloxymethyl) Ester Impurity E
EINECS	Contact for details

Quality Control

Every batch of Adefovir Dipivoxil Impurity E is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and supporting its use as a reference standard. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.