High-Purity Ganciclovir Sodium API | CAS 107910-75-8

Ganciclovir Sodium (CAS No. 107910-75-8) is a potent synthetic nucleoside analogue of 2'-deoxyguanosine. As a broad-spectrum antiviral Active Pharmaceutical Ingredient (API), it exhibits exceptional inhibitory activity against the Herpesviridae family, particularly Cytomegalovirus (CMV). Manufactured under strict cGMP-compliant protocols, Xi'an Tihealth provides pharmaceutical-grade Ganciclovir Sodium characterized by a validated HPLC purity of ≥99.0%. Due to its high aqueous solubility, it is specifically engineered for the industrial formulation of sterile lyophilized powders for injection and high-concentration parenteral solutions, ensuring rapid systemic absorption and reliable therapeutic outcomes in immunocompromised patients.

To ensure the safety and efficacy of sterile antiviral formulations, our Ganciclovir Sodium undergoes exhaustive analytical profiling in accordance with USP/EP standards:

Ganciclovir Sodium functions as a highly selective prodrug, requiring intracellular activation within virus-infected cells:

• Selective Phosphorylation: In CMV-infected cells, the conversion of Ganciclovir to Ganciclovir Monophosphate is catalyzed by a viral protein kinase (encoded by the UL97 gene). This ensure the active triphosphate form accumulates primarily in infected cells.
• Competitive Polymerase Inhibition: Ganciclovir triphosphate acts as a structural analogue of dGTP, competitively inhibiting viral DNA polymerase and preventing the incorporation of natural guanosine into viral DNA.
• Chain Termination: Once incorporated into the growing viral DNA strand, it acts as a terminal inhibitor, halting further elongation and irreversibly arresting viral replication.

• Parenteral Injectables (IV): The definitive API for formulating lyophilized powders for injection (500mg/vial), critical for treating life-threatening CMV infections in transplant recipients and HIV patients.
• Ophthalmic R&D: Utilized in the development of advanced intravitreal inserts or topical gels for CMV retinitis management.
• Biomedical Research: Serves as a standard tool compound for investigating viral resistance mechanisms and DNA polymerase kinetics.

Ganciclovir Sodium (CAS 107910-75-8) offers significantly higher aqueous solubility compared to the free base form. This enhanced solubility is essential for formulating high-concentration intravenous (IV) solutions and ensures a rapid onset of action in acute clinical viral management.

Does this API comply with USP endotoxin limits for sterile injectables?

Absolutely. Our Ganciclovir Sodium is manufactured with strict control over bacterial endotoxins (≤ 0.5 EU/mg), making it an ideal starting material for compounding into sterile lyophilized powders for parenteral administration.

How do you ensure the stability of Ganciclovir Sodium during transport?

Ganciclovir Sodium is hygroscopic. We utilize vacuum-sealed, light-resistant pharmaceutical-grade packaging with desiccant protection. For long-term storage, we recommend maintaining the product in a tightly sealed container at room temperature, protected from direct light and moisture.