Description

Adefovir Dipivoxil Impurity 23 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for the quality control and regulatory compliance of Adefovir Dipivoxil, an antiviral medication. It is primarily required by analytical laboratories, research institutions, and pharmaceutical companies engaged in method validation, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of specific impurities in Adefovir Dipivoxil active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure that Adefovir Dipivoxil batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to characterize and justify impurity limits in drug dossiers (ICH guidelines).
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Adefovir Dipivoxil.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 23
CAS No.	1215101-42-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Adefovir Dipivoxil Related Compound 23; Adefovir Dipivoxil EP Impurity J; Adefovir Dipivoxil USP Impurity; 9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine Impurity; PMEA Dipivoxil Impurity 23; Bis(POM)PMEA Impurity 23; GS 840 Impurity
EINECS	Contact for details

Quality Control

Our Adefovir Dipivoxil Impurity 23 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided to support your regulatory and quality requirements.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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