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 a critical component for life-saving antiviral therapies. It is primarily utilized by pharmaceutical manufacturers in the research, development, and large-scale production of antiviral medications, particularly for the treatment of HIV and Hepatitis B.

Application

• Antiviral Drug Manufacturing: Primary use as the active pharmaceutical ingredient (API) in the formulation of antiretroviral combination therapies for HIV/AIDS.
• Hepatitis B Treatment: Key component in oral medications designed to suppress Hepatitis B virus (HBV) replication.
• Pharmaceutical Research & Development: Serves as a reference standard and a key intermediate in the discovery and development of new antiviral agents.
• Generic Drug Production: Essential for manufacturers producing generic versions of established antiviral drugs containing Lamivudine.
• Fixed-Dose Combination (FDC) Tablets: Used in combination with other antiretroviral agents (e.g., Zidovudine, Tenofovir) to create simplified treatment regimens.
• Clinical Trial Materials: Supplied as a high-purity compound for use in clinical studies and bioequivalence testing.

Basic Information

Product Name	Lamivudine
CAS No.	134678-17-4
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	(-)-Lamivudine; 3TC; (-)-2',3'-Dideoxy-3'-thiacytidine; (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine; BCH-189; GR-109714X; Epivir (Brand Name); Heptavir; Heptodin
EINECS	Contact for details

Quality Control

Our Lamivudine is manufactured under strict quality management systems. We offer grades compliant with major pharmacopoeial standards, including USP and EP. Every batch undergoes rigorous analytical testing to ensure identity, purity, and potency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product 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 conforms to reference standard
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
Sulfated Ash	≤ 0.1%

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