Product Description
gentamycin sulphate GMP USP/EP/BP 1405-41-0
AI Product Description
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Gentamicin Sulphate is a widely utilized aminoglycoside antibiotic derived from the bacterium *Micromonospora purpurea*. It serves as a critical therapeutic agent in clinical settings for treating severe infections caused by susceptible Gram-negative bacteria, including *Pseudomonas aeruginosa*, *Escherichia coli*, and *Klebsiella* species. The product adheres to stringent quality standards defined by major pharmacopoeias, specifically the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP). These specifications ensure high purity, potency, and safety for pharmaceutical manufacturing under Good Manufacturing Practice (GMP) guidelines.
The chemical identity of Gentamicin Sulphate is characterized by its molecular formula, C21H43N5O7·xH2SO4, reflecting its complex structure composed of gentamicin components A1, A2, B1, B1a, and C1 combined with sulfuric acid. Its unique CAS Registry Number is 1405-41-0, which is essential for precise identification in global supply chains and regulatory documentation. As a broad-spectrum antibiotic, it functions by irreversibly binding to the 30S ribosomal subunit of bacteria, thereby inhibiting protein synthesis and leading to bacterial cell death. This mechanism makes it highly effective against multidrug-resistant strains where other antibiotics fail.
In addition to human medicine, Gentamicin Sulphate finds applications in veterinary medicine for treating livestock infections and occasionally in agricultural formulations. However, its use requires careful monitoring due to potential side effects such as nephrotoxicity and ototoxicity. Pharmaceutical manufacturers prioritize GMP-certified raw materials to guarantee batch consistency and sterility. The sulphate salt form enhances solubility and stability, making it ideal for injection solutions, ophthalmic drops, and topical creams. Regulatory compliance with USP, EP, and BP monographs ensures that the product meets rigorous international benchmarks for impurities, assay, and dissolution profiles. Consequently, Gentamicin Sulphate remains a cornerstone in antimicrobial therapy, balancing efficacy with safety when administered under professional supervision. Its availability in certified grades supports diverse medical needs globally, reinforcing its status as an indispensable component of modern healthcare systems.