Description

Truvada CAS NO 731772-45-5 is a high-purity active pharmaceutical ingredient (API) primarily recognized as a key component in pre-exposure prophylaxis (PrEP) and combination antiretroviral therapy (ART). Its significance lies in its proven efficacy in reducing the risk of HIV transmission and managing HIV infection, making it a cornerstone of modern public health strategies. This compound is essential for global pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) focused on antiviral therapeutics and preventative medicine.

Application

• Pharmaceutical API: Primary use as the active ingredient in fixed-dose combination tablets for HIV treatment and prevention.
• Pre-Exposure Prophylaxis (PrEP): Formulation into preventative medications to reduce the risk of HIV infection in high-risk populations.
• Antiretroviral Therapy (ART): A critical component in combination therapies for managing HIV-1 infection.
• Clinical Research: Used as a reference standard and raw material in pharmacokinetic, bioequivalence, and new drug formulation studies.
• Contract Manufacturing: Supplied to CDMOs for the production of generic and branded antiviral medications.
• Regulatory Submissions: Sourced for drug master file (DMF) submissions and regulatory compliance dossiers for health authorities like the FDA and EMA.

Basic Information

Item	Detail
Product Name	Truvada
CAS No.	731772-45-5
Molecular Formula	C23H30F3N5O3P
Molecular Weight	512.49 g/mol
Synonyms	Tenofovir Disoproxil Fumarate; TDF; (R)-PMPA; Bis(POC)PMPA; Gilead 4331; GS 4331; GS-4331; Viread (brand name component); Tenofovir Disoproxil Fumarate (TDF); Tenofovir DF; 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1)
EINECS	Contact for details

Quality Control

Our Truvada API is manufactured under strict cGMP guidelines to ensure the highest standards of purity and consistency. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to meet or exceed pharmacopeial specifications (USP/EP). A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with your specified requirements.

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 in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Limits	Complies with USP <61> and <62>

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