Description

Tenofovir Related Compound 4 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of antiviral medications. This compound is critical for ensuring the accuracy and reliability of analytical methods, particularly in the characterization and impurity profiling of Tenofovir-based Active Pharmaceutical Ingredients (APIs). It serves as an essential tool for researchers and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors who require definitive standards for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the identification and quantification of specific impurities or degradation products in Tenofovir drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH guidelines) for impurity limits.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to monitor the formation of related substances under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development: Utilized in synthetic chemistry R&D for route scouting, process optimization, and the synthesis of novel Tenofovir analogs.

Basic Information

Product Name	Tenofovir Related Compound 4
CAS No.	851456-00-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Impurity 4; Tenofovir Related Substance 4; Tenofovir EP Impurity D; Tenofovir USP Related Compound 4; PMPA Related Compound 4; (R)-9-(2-Phosphonomethoxypropyl)adenine Related Compound 4; GS-1278 Related Compound
EINECS	Contact for details

Quality Control

Our Tenofovir Related Compound 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and analytical performance.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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