Description

Emtricitabine CAS NO 13405-87-3 is a potent nucleoside reverse transcriptase inhibitor (NRTI) of significant pharmaceutical importance. This active pharmaceutical ingredient (API) is a cornerstone in modern antiretroviral therapy, valued for its high efficacy and favorable safety profile. It is primarily required by pharmaceutical manufacturers and research institutions for the formulation of combination therapies targeting HIV-1 and Hepatitis B virus infections.

Application

• Antiretroviral Drug Manufacturing: A critical API in fixed-dose combination (FDC) tablets for the treatment of HIV-1 infection.
• Hepatitis B Therapeutics: Used in the development and production of antiviral medications for chronic Hepatitis B.
• Pharmaceutical Research & Development: Serves as a key reference standard and building block in the discovery of new antiviral agents and combination regimens.
• Generic Drug Formulation: Essential for manufacturers producing bioequivalent generic versions of leading antiretroviral drugs.
• Pre-Exposure Prophylaxis (PrEP): A component in formulations developed for HIV prevention strategies.
• Analytical Standard: Used in quality control laboratories as a high-purity standard for HPLC, LC-MS, and other analytical methods.

Basic Information

Product Name	Emtricitabine
CAS No.	13405-87-3
Molecular Formula	C8H10FN3O3S
Molecular Weight	247.25 g/mol
Synonyms	FTC; Coviracil; (-)-FTC; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine; 2',3'-Dideoxy-5-fluoro-3'-thiacytidine; BW 524W91; Emtriva; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one
EINECS	Contact for details

Quality Control

Our Emtricitabine is manufactured under strict quality systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopoeial standards (USP/EP). Every batch undergoes comprehensive analytical testing, including identity, purity, and impurity profile determination. A Certificate of Analysis (COA) detailing all test results is provided with each shipment to ensure full traceability and regulatory support for our customers.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Optical Rotation	-130° to -140° (c=1, H2O)

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