Description

Lamivudine is a potent nucleoside reverse transcriptase inhibitor (NRTI) with significant antiviral activity. This active pharmaceutical ingredient (API) is a cornerstone in the global fight against viral infections, offering high efficacy and a well-established safety profile. It is essential for pharmaceutical manufacturers developing antiviral medications, particularly for the treatment of HIV and Hepatitis B.

Application

• Antiretroviral Drug Manufacturing: Primary active ingredient in combination therapies for the treatment of Human Immunodeficiency Virus (HIV-1 and HIV-2) infection.
• Hepatitis B Treatment: Key component in oral antiviral medications for the management of chronic Hepatitis B virus (HBV) infection.
• Pharmaceutical Research & Development: Used as a reference standard and building block in the discovery and development of new antiviral agents and combination therapies.
• Generic Drug Formulation: Critical API for the production of cost-effective, high-quality generic antiviral medications, improving global access to essential treatments.
• Fixed-Dose Combination (FDC) Products: Incorporated into multi-drug tablets and capsules alongside other antiretrovirals for simplified treatment regimens.
• Pre-Exposure Prophylaxis (PrEP): Component in certain combination drugs used for HIV prevention in high-risk populations.

Basic Information

Product Name	Lamivudine
CAS No.	131086-21-0
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	(-)-Lamivudine; 3TC; BCH-189; GR-109714X; Epivir (Brand Name); (2R,5S)-4-Amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone; 2'-Deoxy-3'-thiacytidine; cis-1-(2-Hydroxymethyl-1,3-oxathiolan-5-yl)cytosine
EINECS	Contact for details

Quality Control

Our Lamivudine is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP, EP, and BP. Every batch undergoes rigorous analytical testing for identity, purity, and potency. A comprehensive Certificate of Analysis (COA), detailing results for assay, related substances, residual solvents, and microbiological quality, is provided to ensure full traceability and regulatory support for your pharmaceutical applications.

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 in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere packing.

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)	NMT 1.0%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%
Microbial Enumeration	Complies with EP/USP <61> for non-sterile substances

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