Description

Tenofovir Impurity 75 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of antiviral drugs. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by serving as a well-characterized impurity marker. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers involved in the synthesis, validation, and regulatory compliance of Tenofovir and its related formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) APIs.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during API manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance purity meets pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Tenofovir-based products.
• Research & Development: Utilized in synthetic chemistry research to study the formation and control of process-related impurities.

Basic Information

Product Name	Tenofovir Impurity 75
CAS No.	30566-31-5
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethoxy]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Impurity; Tenofovir Related Compound 75; (R)-9-[2-(Phosphonomethoxy)propyl]adenine Impurity; GS-1278 Impurity; Adefovir Impurity; Bis(POC)PMPA Impurity
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 75 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.