Description

Adefovir Dipivoxil Impurity 2 is a designated impurity standard used in the pharmaceutical development and quality control of Adefovir Dipivoxil, an antiviral medication. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Adefovir Dipivoxil API and finished dosage forms.
• Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and quantify degradation products.
• Quality Control (QC) & Batch Release: A critical component in the QC testing of Adefovir Dipivoxil to ensure batches meet stringent pharmacopeial (e.g., USP, EP) specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports synthetic route optimization and impurity profiling during the drug development process.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 2
CAS No.	1416439-02-5
Molecular Formula	C20H32N5O8P
Molecular Weight	501.47 g/mol
Synonyms	9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine Impurity 2; Adefovir Dipivoxil Related Compound 2; PMEA Dipivoxil Impurity 2; Bis(POM)PMEA Impurity 2; GS 840 Impurity 2
EINECS	Contact for details

Quality Control

Our Adefovir Dipivoxil Impurity 2 is manufactured 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 reference materials. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.