Description

Tenofovir Impurity 86 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tenofovir-based active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification as a certified reference material.
• Analytical Method Development and Validation for Tenofovir and its related drug substances.
• Quality Control (QC) and Quality Assurance (QA) testing in API manufacturing to monitor and control impurity levels.
• Stability Studies to identify and quantify degradation products in drug formulations.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development into the metabolism, pharmacokinetics, and toxicology of Tenofovir.

Basic Information

Product Name	Tenofovir Impurity 86
CAS No.	1878175-74-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 86; Tenofovir EP Impurity 86; Tenofovir USP Impurity 86; Tenofovir Process Impurity; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity; PMPA Impurity; GS-1278 Impurity; TAF Impurity
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity 86 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications and supporting use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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