Description

Adefovir Impurity 12 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes of antiviral medications. This compound is critical for ensuring the safety and efficacy of drug products by serving as a benchmark for identifying and quantifying process-related impurities. It is primarily utilized by analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology industries. The availability of a well-characterized impurity standard is essential for meeting stringent regulatory requirements for drug substance and drug product filings.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Adefovir dipivoxil and related drug substances.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing of active pharmaceutical ingredients (APIs) to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation over time and under various stress conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Research & Development: Used in synthetic route optimization and process chemistry to understand and minimize the formation of this specific impurity.

Basic Information

Product Name	Adefovir Impurity 12
CAS No.	20245-85-6
Molecular Formula	C8H12N5O4P
Molecular Weight	273.19 g/mol
Synonyms	9-[2-(Phosphonomethoxy)ethyl]adenine; PMEA; Adefovir Impurity C; Adefovir Related Compound C; (2-(6-Amino-9H-purin-9-yl)ethoxy)methylphosphonic acid; GS 0393; 9-(2-Phosphonylmethoxyethyl)adenine
EINECS	Contact for details

Quality Control

Every batch of Adefovir Impurity 12 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (CoA) is provided with each shipment, confirming identity, purity, and traceability. Our quality processes are designed to support compliance with cGMP and relevant ICH guidelines.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. 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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.