Description

Adefovir Dipivoxil Impurity 26 is a designated impurity standard used in the analytical profiling and quality control of the antiviral pharmaceutical Adefovir Dipivoxil. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Adefovir Dipivoxil active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by identifying and quantifying specific synthetic intermediates or by-products.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 26
CAS No.	162612-57-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Adefovir Dipivoxil Related Compound 26; Adefovir Dipivoxil Impurity F; Adefovir Dipivoxil EP Impurity F; Adefovir Dipivoxil USP Impurity; 9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine Impurity; PMEA Bis(POM) Impurity 26; GS 840 Impurity
EINECS	Contact for details

Quality Control

Every batch of Adefovir Dipivoxil Impurity 26 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets requirement
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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