Description

Tenofovir Impurity E is a high-purity reference standard critical for the analytical profiling and quality control of Tenofovir-based Active Pharmaceutical Ingredients (APIs). This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is primarily used in the research, development, and quality assurance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Tenofovir and its prodrugs (e.g., Tenofovir Disoproxil Fumarate).
• Analytical Research: Used in HPLC, UPLC, and LC-MS analysis for the precise identification and quantification of Tenofovir Impurity E in API batches and finished drug products.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this impurity during forced degradation and long-term stability studies of antiviral formulations.
• Process Chemistry & Optimization: Used by R&D scientists to understand and minimize the formation of this impurity during the API synthesis and purification processes.

Basic Information

Product Name	Tenofovir Impurity E
CAS No.	1796545-19-1
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethoxy]phenoxyphosphinyl]methoxy]propyl]adenine; Tenofovir Related Compound E; PMPA Impurity E; GS-1278 Impurity; (R)-PMPA Impurity; 9-[2-[[[(1S)-1-(Isopropoxycarbonyl)ethoxy]phenoxyphosphinyl]methoxy]propyl]adenine; Adenine, 9-[2-[[[(1S)-1-[(1-methylethoxy)carbonyl]ethoxy]phenoxyphosphinyl]methoxy]propyl]-; Tenofovir Isomer Impurity
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity E is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, supporting compliance with ICH Q3A/B guidelines and current Good Manufacturing Practices (cGMP).

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 inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.