Description

Adefovir Dipivoxil N6-Hydroxymethyl Impurity is a specified impurity and a key reference standard used in the quality control of the active pharmaceutical ingredient (API) Adefovir Dipivoxil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers engaged in the production and regulatory compliance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of the N6-Hydroxymethyl impurity in Adefovir Dipivoxil API and finished dosage forms.
• Method Development & Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, to monitor impurity profiles during API synthesis.
• Quality Assurance & Control (QA/QC): Used in routine batch release testing to ensure impurity levels are within the strict limits set by pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation impurities in Adefovir Dipivoxil under various storage conditions over time.
• Process Chemistry Research: Serves as a marker to optimize synthesis pathways, minimize the formation of this specific impurity, and improve overall process yield and purity.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive control over the drug substance's impurity profile.

Basic Information

Product Name	Adefovir Dipivoxil N6-Hydroxymethyl Impurity
CAS No.	323201-04-3
Molecular Formula	C20H32N5O8P
Molecular Weight	501.47 g/mol
Synonyms	N6-(Hydroxymethyl) Adefovir Dipivoxil; Adefovir Dipivoxil Impurity F (EP); Adefovir Dipivoxil Related Compound F; 9-[2-[[Bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine N6-Hydroxymethyl Derivative; PMEA Dipivoxil N6-Hydroxymethyl Impurity; [[(2-(6-(Hydroxymethyl)amino)-9H-purin-9-yl)ethoxy]methylphosphinoyl]bis(oxy-2,1-ethanediyl) pivalate; Adefovir Dipivoxil EP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Adefovir Dipivoxil N6-Hydroxymethyl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS 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 inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0%
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.