Description

Tenofovir Alafenamide o-Desphenyl Impurity is a key process-related impurity and degradation product encountered during the synthesis and stability studies of the active pharmaceutical ingredient (API) Tenofovir Alafenamide. This compound is of critical importance for pharmaceutical manufacturers and analytical laboratories for method development, validation, and ensuring the quality and safety of the final drug product. It is primarily required by professionals in pharmaceutical R&D, quality control, and regulatory affairs for impurity identification, reference standard qualification, and compliance with stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Tenofovir Alafenamide drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to accurately detect and quantify this specific impurity.
• Stability Studies & Forced Degradation: Employed in stability-indicating method studies to understand the degradation pathways and shelf-life of Tenofovir Alafenamide formulations.
• Quality Control & Batch Release: Serves as a system suitability and identification standard in routine QC testing to ensure API and drug product batches meet specified impurity limits.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity profiles, specifications, and control strategies.
• Process Chemistry Research: Used by chemists to study and optimize the synthetic route of Tenofovir Alafenamide to minimize the formation of this impurity.

Basic Information

Product Name	Tenofovir Alafenamide o-Desphenyl Impurity
CAS No.	376633-26-0
Molecular Formula	C21H29N6O5P
Molecular Weight	476.47 g/mol
Synonyms	Tenofovir Alafenamide Desphenyl Impurity; TAF o-Desphenyl Impurity; GS-7340 o-Desphenyl Impurity; (R)-PMPA O-(pivaloyloxymethyl) N-((isopropoxycarbonyl)oxy)phosphoramidate Desphenyl Analog; 9-[(R)-2-[[(S)-[[(S)-(1-Isopropoxycarbonyloxy)ethoxy]phenoxyphosphinyl]amino]propionyl]amino]propyl]adenine Derivative; Tenofovir Alafenamide Related Compound; Tenofovir Alafenamide Impurity C; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Tenofovir Alafenamide o-Desphenyl Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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