Description

Amikacin Disulfate is a semi-synthetic aminoglycoside antibiotic derived from kanamycin A. This compound is critical for its potent bactericidal activity against a wide spectrum of Gram-negative and some Gram-positive bacteria, including strains resistant to other aminoglycosides. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the formulation of injectable antibiotic solutions.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable formulations for the treatment of severe systemic infections.
• Hospital & Clinical Use: Formulated into solutions for intramuscular or intravenous injection to combat serious infections like septicemia, respiratory tract infections, and complicated urinary tract infections.
• Veterinary Medicine: Used in the development of antibiotic treatments for bacterial infections in animals.
• Research & Development: Serves as a critical reference standard and raw material in microbiological research and the development of new antibacterial agents.
• Manufacturing of Finished Dosage Forms: Utilized by contract manufacturing organizations (CMOs) for the large-scale production of finished, packaged injectable drugs.

Basic Information

Product Name	Amikacin Disulfate
CAS No.	39831-55-5
Molecular Formula	C22H43N5O13 • 2H2SO4
Molecular Weight	781.76 g/mol (free base: 585.60)
Synonyms	Amikacin Sulfate; Amikacin Sulphate; Amikacin Disulphate; 1-N-[(S)-4-Amino-2-hydroxybutyryl]-6'-O-(3-amino-3-deoxy-α-D-glucopyranosyl)kanamycin A Disulfate; BAY 41-6551 (as sulfate); Amikacini sulfas; Amikacinum; Amikacini disulfas
EINECS	Contact for details

Quality Control

Our Amikacin Disulfate is manufactured and tested under a strict quality management system. It is produced to meet high-purity standards suitable for pharmaceutical applications, with testing typically including identification, assay, impurity profiling, and specific tests for related substances. Certificates of Analysis (COA) confirming compliance with in-house specifications are available upon request. We can support development projects requiring alignment with pharmacopeial standards such as USP or EP.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC, on anhydrous basis)	95.0% - 102.0%
pH (1% solution)	Contact for details
Water (Karl Fischer)	≤ 8.0%
Residue on Ignition	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 2.0% Total impurities: ≤ 5.0%
Bacterial Endotoxins	< 1.0 EU/mg (as applicable)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.