Product Description
Amikacin Sulfate is the sulfate salt of amikacin, a broad-spectrum semi-synthetic aminoglycoside antibiotic, derived from kanamycin with antimicrobial property. Amikacin irreversibly binds to the bacterial 30S ribosomal subunit, specifically in contact with 16S rRNA and S12 protein within the 30S subunit. This leads to interference with translational initiation complex and misreading of mRNA, thereby hampering protein synthesis and resulting in bactericidal effect. This agent is usually used in short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria.
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Comprehensive Quality StandardsAmikacin Sulphate easily passes pharmaceutical-grade standards, evidenced by its excellent assay results and compliance with endotoxin, pH, heavy metal, and residue controls. Each batch undergoes thorough testing, ensuring purity exceeds 99% and water content stays under 12%. These controls guarantee consistent performance for medical use.
Primary Uses and BenefitsThis antibiotic is critical in the management of severe bacterial infections, particularly when other treatments are ineffective. Its potent antibacterial action and favorable solubility in water make it a reliable choice for tailored pharmaceutical formulations. Healthcare providers rely on Amikacin Sulphate both for effectiveness and safety in serious clinical settings.
Handling, Storage, and Shelf LifeStore Amikacin Sulphate in a cool, dry place away from direct light to preserve its stability and potency. Under proper storage, the product maintains its efficacy for up to three years from the date of manufacture. Its stable, non-poisonous nature makes it manageable in most pharmaceutical environments.
FAQ's of Amikacin Sulphate:
Q: How is Amikacin Sulphate typically used in medical treatments?
A: Amikacin Sulphate serves as an active pharmaceutical ingredient in injectable antibiotics designed for severe bacterial infections. It is administered under medical supervision as part of hospital-based therapies, especially when other antibiotics fail.
Q: What quality standards does Amikacin Sulphate comply with?
A: Each batch is rigorously tested to comply with pharmacopeial standards, including limits on residue on ignition (<1.0%), endotoxin levels (<0.5 IU/mg), pH (4.5-6.5), water content (<12.0%), and heavy metals (<0.001%). Related substances and identification tests are also carried out to ensure purity.
Q: When should Amikacin Sulphate be used over other antibiotics?
A: This compound is preferred when bacterial infections are severe or resistant to other antibiotics. It is used according to doctor's recommendation, particularly in hospital settings where potent, broad-spectrum activity is necessary.
Q: Where should Amikacin Sulphate be stored to maintain its stability?
A: Store the powder in a cool, dry place, and keep it protected from light. Proper storage is essential to maintain its efficacy and maximize its three-year shelf life.
Q: What is the process for verifying the purity and quality of Amikacin Sulphate?
A: Purity and quality are assessed through HPLC assay (not less than 900 g/mg of C22H43N5O13S), microbiological testing, endotoxin level checks, specific optical rotation, and various compliance tests as stipulated by pharmacopeial standards.
Q: What benefits does Amikacin Sulphate offer to manufacturers and healthcare providers?
A: The product assures consistent pharmacological performance, high purity, and reliable compliance with international quality standards, making it a preferred choice for safe and effective pharmaceutical production and patient care.
Q: Is Amikacin Sulphate toxic or harmful to handle in standard pharmaceutical environments?
A: It is considered non-poisonous under normal conditions and can be safely handled and processed in well-regulated pharmaceutical settings when standard hygiene and protective measures are followed.