Description

Tenofovir is a potent nucleotide reverse transcriptase inhibitor (NRTI) that serves as a critical active pharmaceutical ingredient (API) in antiviral therapies. Its primary value lies in its efficacy against HIV-1, hepatitis B virus (HBV), and other retroviruses, forming the backbone of numerous life-saving antiretroviral regimens. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing and producing solid oral dosage forms, combination therapies, and novel drug delivery systems. Global demand is driven by its inclusion in first-line treatment protocols and its role in pre-exposure prophylaxis (PrEP).

Application

• Antiretroviral Drug Manufacturing: Primary API for the synthesis of Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) tablets and capsules.
• HIV/AIDS Treatment: Core component in combination antiretroviral therapy (cART) regimens to inhibit viral replication.
• Chronic Hepatitis B Therapy: Used in antiviral medications for the long-term management of HBV infection.
• Pre-Exposure Prophylaxis (PrEP): Key ingredient in formulations used to prevent HIV infection in high-risk populations.
• Pharmaceutical Research & Development: Serves as a reference standard and starting material for developing new prodrugs, fixed-dose combinations, and generics.
• Analytical and Quality Control: Used as a certified reference material (CRM) in HPLC, LC-MS, and other analytical methods for assay and impurity profiling.

Basic Information

Product Name	Tenofovir
CAS No.	14047-26-8
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	(R)-9-(2-Phosphonomethoxypropyl)adenine; PMPA; GS-1278; (R)-PMPA; (R)-9-[2-(Phosphonomethoxy)propyl]adenine; (2R)-1-(6-Amino-9H-purin-9-yl)propan-2-yloxymethylphosphonic acid; TDF Intermediate; Tenofovir Free Acid
EINECS	Contact for details

Quality Control

Our Tenofovir is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identification, assay, and impurity profiling via advanced techniques like HPLC and LC-MS. We provide full traceability and support regulatory submissions with comprehensive documentation. Certificates of Analysis (COA) detailing purity, related substances, residual solvents, and other critical parameters are available for every shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency. The storage area should be well-ventilated and separate from strong oxidizing agents.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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