About Itraconazole Pellets
Itraconazole Pellets
Other Name : 2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
CAS Number : 84625-61-6
Molecular Formula : C35H38CI2N8O4
Application : Anti Fungal. Used in the treatment of stomach upset/ indigestion and other gastrointestinal conditions
Comprehensive Antifungal SolutionItraconazole Pellets deliver a reliable approach for pharmaceutical manufacturers targeting both systemic and superficial fungal infections. Featuring customizable particle size, controlled or immediate release, and compatibility with oral dosage forms, these pellets meet stringent international standards (USP/IP/BP) and regulatory compliance, ensuring both efficacy and safety in antifungal therapy.
Stringent Quality and StabilityEach batch of Itraconazole Pellets is thoroughly tested to ensure moisture and loss on drying do not exceed 2.0%, while assay levels are tightly regulated for consistency. The neutral pH and odorless nature make them suitable for a range of oral pharmaceutical formulations, with a solid 36-month shelf life when stored properly.
FAQs of Itraconazole Pellets:
Q: How are Itraconazole Pellets typically used in pharmaceutical formulations?
A: Itraconazole Pellets are mainly used in oral formulations, such as capsules, for the treatment of systemic and superficial fungal infections. Formulators can select either controlled or immediate release profiles depending on therapeutic requirements.
Q: What are the storage requirements for maintaining the quality of Itraconazole Pellets?
A: These pellets should be stored in a cool, dry place, away from direct sunlight, ideally in their original HDPE drums with double polyethylene bags to preserve quality and maximize their 36-month shelf life.
Q: When should Itraconazole Pellets be chosen over other antifungal agents?
A: Itraconazole Pellets are preferred when high assay accuracy, customized particle size, versatile release profiles, and proven efficacy against multiple fungal infections are required, especially in oral dosage forms.
Q: Where are these pellets generally produced and distributed?
A: Itraconazole Pellets are manufactured, distributed, and exported by numerous reputable companies across India, catering to the needs of pharmaceutical manufacturers, exporters, importers, and retailers worldwide.
Q: What is the process for ensuring the assay and purity of these pellets meet regulatory standards?
A: Every batch is tested using advanced techniques, such as HPLC, ensuring the Itraconazole content is between 90% to 110% of the labeled amount, and a purity level of at least 98%. Additional pharmacopoeial tests verify compliance with global standards.
Q: What are the benefits of using these pellets in oral antifungal therapy?
A: Itraconazole Pellets offer precise dosing, customizable release profiles, reliable stability, and compatibility with a wide array of excipients. Their neutral pH and odorless, bitter-tasting formulation facilitate integration into diverse capsule and oral tablet products.