Description

Tenofovir Disoproxil Impurity 44 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during the development and manufacturing of Tenofovir Disoproxil Fumarate. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and fine chemical industries to ensure product safety and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for method development and validation in HPLC, UPLC, and LC-MS analysis.
• Quality Assurance & Control (QA/QC): Used for routine batch testing and release of Tenofovir Disoproxil Fumarate API and finished drug products to meet ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and control strategies.
• Research & Development (R&D): Utilized in stability studies, degradation pathway elucidation, and process chemistry optimization.
• Pharmacopeial Testing: Acts as a system suitability standard for tests prescribed in USP, EP, or other pharmacopeias.
• Contract Research Organizations (CROs): Supports analytical services for clients requiring precise impurity identification and quantification.

Basic Information

Product Name	Tenofovir Disoproxil Impurity 44
CAS No.	201340-97-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Impurity 44; Tenofovir Disoproxil Related Compound 44; 9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethoxy]methoxy]phosphinyl]methoxy]propyl]adenine Impurity; PMPA Impurity; GS 4331 Impurity; Bis(POC)-PMPA Impurity; Tenofovir Disoproxil Fumarate Impurity 44
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Disoproxil Impurity 44 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulated environments.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.