Description

Adefovir Dipivoxil Impurity 38 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiviral drug Adefovir Dipivoxil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for maintaining the stringent purity standards demanded in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Adefovir Dipivoxil API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for the API.

Basic Information

Product Name	Adefovir Dipivoxil Impurity 38
CAS No.	162612-59-1
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 38; Bis(POM)PMEA; Adefovir Pivaloyloxymethyl Ester Impurity; GS 0840 Impurity; Hepsera Impurity
EINECS	Contact for details

Quality Control

Every batch of Adefovir Dipivoxil Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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