Description

Adefovir Dipivoxil Impurity 1 is a designated impurity standard used in the analytical profiling of the antiviral pharmaceutical Adefovir Dipivoxil. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling precise identification and quantification of related substances. It is an essential reference material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on antiviral drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Adefovir Dipivoxil active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Adefovir Dipivoxil under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control.
• Pharmaceutical Research: Used in research to understand the degradation pathways and metabolic profile of Adefovir Dipivoxil.
• Calibration and System Suitability: Acts as a calibrant to ensure the accuracy and precision of analytical instrumentation used in QC laboratories.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 1
CAS No.	1215101-40-8
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 1; Bis(POM)PMEA; Adefovir Pivaloyloxymethyl Ester Impurity; GS 0840 Impurity
EINECS	Contact for details

Quality Control

Every batch of Adefovir Dipivoxil Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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