USP Standard Lamivudine CAS 134678-17-4

Lamivudine  More Info

Lamivudine (CAS No. 134678-17-4) is a synthetic nucleoside reverse transcriptase inhibitor (NRTI) first approved for medical use in the 1990s. It is chemically designated as 2',3'-dideoxy-3'-thiacytidine (3TC) and functions by incorporating itself into viral DNA chains during replication, leading to premature termination of viral genetic synthesis. Its development marked a significant advancement in antiviral therapy, particularly for chronic viral infections, and it remains a structurally optimized molecule with well-characterized pharmacokinetic properties.

Applications and Fields of Use

This pharmaceutical compound is primarily used in the treatment of HIV-1 and hepatitis B virus (HBV) infections. In HIV therapy, it is consistently included in combination antiretroviral regimens (e.g., with zidovudine or tenofovir) to suppress viral replication. For HBV management, it serves as a monotherapy or component of dual therapy to reduce viral load and improve liver function. Beyond human medicine, it is utilized in veterinary applications and biomedical research to study viral resistance mechanisms and combination therapy efficacy.

Market Relevance

Lamivudine maintains a stable global market due to its essential role in generic antiviral therapy, particularly in low- and middle-income countries. It is listed on the WHO Essential Medicines List and manufactured by multiple generic pharmaceutical companies under stringent regulatory oversight (e.g., FDA, WHO PQ). Demand is sustained by the persistent prevalence of HIV/HBV co-infections and its use in preventive protocols (e.g., perinatal HIV transmission prevention). Emerging markets in Africa and Asia continue to drive volume-based procurement.

Handling and Regulatory Considerations

As a prescription pharmaceutical, Lamivudine must be handled in compliance with Good Manufacturing Practices (GMP) and pharmaceutical safety guidelines. Personnel should use appropriate personal protective equipment (PPE) to minimize exposure during processing or research activities. Storage requires controlled room temperature protection from moisture. Regulatory frameworks classify it as a prescription-only substance, and all applications must adhere to regional pharmacopoeia standards (e.g., USP, EP). Environmental precautions include proper disposal to avoid aquatic contamination due to its potential ecological persistence.