Description

Tenofovirdisoproxil Impurity CAS NO 1796539-92-8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of Tenofovir Disoproxil-based drug products by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in the pharmaceutical and biotechnology sectors. The impurity standard supports compliance with stringent regulatory requirements for drug substance and drug product characterization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Tenofovir Disoproxil Fumarate active pharmaceutical ingredient (API) and its formulations.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control (QC) and Quality Assurance (QA): Used in routine batch release testing to monitor impurity profiles and ensure product consistency meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development (R&D): Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Tenofovirdisoproxil Impurity
CAS No.	1796539-92-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Disoproxil Related Compound; Tenofovir Disoproxil Impurity; Tenofovir Impurity; TDF Impurity; 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine Impurity; (R)-PMPA Bis(POC) Impurity; GS 4331 Impurity; Viread Impurity
EINECS	Contact for details

Quality Control

Our Tenofovirdisoproxil Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic techniques. We adhere to relevant ICH Q3A/B guidelines for impurities and can support compliance with cGMP standards for pharmaceutical reference materials. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term stability, consider storage at 2-8°C. The container should be kept in a dry, 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.