Description

Adefovir Dipivoxil Impurity 31 is a high-purity chemical reference standard used in the analytical profiling of the antiviral drug Adefovir Dipivoxil. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring drug purity, safety, and regulatory compliance. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Adefovir Dipivoxil.
• Impurity Profiling & Identification: Essential for identifying, characterizing, and monitoring this specific impurity during drug substance and drug product development.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels are within specified limits (ICH guidelines).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity structure, identity, and control strategies.
• Stability Studies: Used to track the formation of this impurity under various stress conditions to determine drug product shelf-life.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 31
CAS No.	1245468-65-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Adefovir Dipivoxil Related Compound 31; Adefovir Dipivoxil Impurity K; Adefovir Pivaloyloxymethyl Ester Impurity 31; 9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine Impurity; PMEA Bis(POM) Impurity 31; GS 840 Impurity 31; Hepsera™ Impurity 31
EINECS	Contact for details

Quality Control

Our Adefovir Dipivoxil Impurity 31 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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