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Amikacin Sulfate

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The pharma-grade sulphate salt of amikacin is the standard form used in injectable human antibiotics, manufactured under stricter GMP controls than generic veterinary-grade material to meet pharmacopoeia monograph requirements.

Amikacin Sulfate
Quick Facts
CAS Number39831-55-5
Molecular FormulaC22H47N5O21S2
Molecular Weight781.76
PharmacopoeiaUSP, EP, CP
Packaging25 KG/DRUM
USP Standard EP/BP Standard GMP Certified

Product Overview

Amikacin Sulfate is a semisynthetic aminoglycoside antibiotic derived from kanamycin. It has the broadest spectrum among aminoglycosides and is resistant to most aminoglycoside-inactivating enzymes, making it a critical agent in human medicine.

Amikacin inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. It is a first-line treatment for serious Gram-negative infections, including those caused by multidrug-resistant organisms (MDROs) such as ESBL-producing Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii.

Quality Specifications

PurityAs per USP monograph
Residual SolventsCompliant with ICH Q3C
Heavy MetalsCompliant with pharmacopoeia limits
GMP StatusManufactured under GMP conditions

Pharmaceutical Applications

  • Hospital-acquired pneumonia: Including ventilator-associated pneumonia (VAP)
  • Complicated urinary tract infections: Including pyelonephritis
  • Septicemia: Severe Gram-negative bacteremia and sepsis
  • Multidrug-resistant tuberculosis: Second-line agent for MDR-TB
  • Febrile neutropenia: Empiric therapy in immunocompromised patients
Standards: USP, EP, CPV  |  CAS: 39831-55-5 (Base) / 149022-22-0 (Sulphate)  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  June 2026

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