Description

Tenofovir Related Compound 5 is a high-purity chemical reference standard and synthetic intermediate. This compound is critical for pharmaceutical research and development, particularly in the quality control and impurity profiling of antiviral drug substances. It is primarily utilized by analytical laboratories and API manufacturers within the pharmaceutical and biotechnology sectors to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of Tenofovir and its prodrugs (e.g., Tenofovir Disoproxil Fumarate) via HPLC, LC-MS, and other chromatographic methods.
• Process Impurity Monitoring: Essential for identifying and quantifying specific process-related impurities during the synthesis and purification of antiviral Active Pharmaceutical Ingredients (APIs).
• Method Development and Validation: Serves as a critical component in developing and validating analytical methods for regulatory submissions (e.g., ICH guidelines).
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Tenofovir-based drug products.
• Chemical Synthesis Intermediate: Acts as a key building block or precursor in the research-scale synthesis of novel nucleotide analog antiviral compounds.
• Quality Assurance/Quality Control (QA/QC): Integral for in-house quality control testing to ensure batch-to-batch consistency and adherence to strict pharmacopeial specifications.

Basic Information

Product Name	Tenofovir Related Compound 5
CAS No.	1234081-04-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Impurity 5; Tenofovir EP Impurity C; Tenofovir Related Substance 5; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity 5; PMPA Related Compound 5; GS-1278 Impurity; Tenofovir Analog 5; TDF Related Compound 5
EINECS	Contact for details

Quality Control

Our Tenofovir Related Compound 5 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, LC-MS). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality commitment aligns with ICH guidelines and supports regulatory requirements for pharmaceutical impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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