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Pharmaceutical Chemistry
Gentamicin sulfate
GOST/CAS:
C21H43N5O7
Gentamicin sulfate is a widely used, broad-spectrum aminoglycoside antibiotic. The product is a white to off-white, hygroscopic crystalline powder, freely soluble in water and practically insoluble in alcohol. It exhibits high thermal stability in solutions. It serves as an indispensable primary raw material (Active Pharmaceutical Ingredient — API) for manufacturing a wide range of finished dosage forms as well as veterinary medicines.
Applications
Pharmaceutical Industry: Production of injectable solutions (ampoules and vials), eye and ear drops, topical ointments, creams, gels, as well as combined anti-inflammatory formulations.
Veterinary Medicine: Manufacture of injection solutions, oral powders, and intramammary mastitis syringes for treating bacterial infections in livestock and companion animals.
Research & Biotechnology: Used in microbiology and tissue culture as a selective agent in growth media to prevent bacterial contamination of cell cultures.
Key Advantages
Broad Spectrum of Activity: Highly effective against most Gram-negative bacteria (including Pseudomonas aeruginosa, E. coli, Proteus spp., Klebsiella spp.) and certain Gram-positive microorganisms.
High Stability: The substance is resistant to temperature variations and retains its potency across a wide pH range, significantly simplifying the technological process of liquid dosage form manufacturing.
Consistent Quality: Fully complies with the stringent requirements of leading global pharmacopoeias (EP, USP, BP, ChP), guaranteeing a high level of purity and minimal related impurities.
Cost-Effectiveness: Due to its high potency and time-tested efficacy, it remains one of the most affordable and commercially demanded antibiotics in its class.
Storage & Transportation
- Store in dry, clean, light-protected warehouse premises in tightly sealed original packaging at temperatures between +15°C and +25°C.
- The product is highly hygroscopic; protect from moisture and direct sunlight.
- Transportation is permitted by all types of covered transport while strictly maintaining the required temperature regime. The substance requires careful handling and must be transported in compliance with regulations for pharmaceutical raw materials.
- Shelf Life: 3 to 5 years from the date of manufacture (depending on the manufacturer and packaging integrity).
Technical Specifications
Appearance
White to cream-white crystalline powder, odorless, hygroscopic.
Potency (on dried basis)
Not less than 590 mcg/mg (IU/mg)
Solubility
Freely soluble in water, thermostable.
pH (4% aqueous solution)
3.5 – 5.5
Loss on Drying
Not more than 18.0%
Specific Optical Rotation
+107° to +121°
Supply info
- Multi-layer paper bags with an inner polyethylene liner: 10 kg / 25 kg.
- Plastic or fiber drums for industrial-scale manufacturing: 25 kg.
- Customized packing into airtight containers of smaller volumes is available upon request.