Description

Tobramycin Sulfate is a potent aminoglycoside antibiotic salt, widely recognized for its efficacy against a broad spectrum of Gram-negative and some Gram-positive bacteria. Its primary value lies in its critical role in pharmaceutical manufacturing, particularly for injectable formulations used in serious systemic infections. This high-purity compound is essential for producers of ophthalmic solutions, inhalation therapies, and parenteral drugs, serving the pharmaceutical, biotechnology, and veterinary medicine industries. The product is supplied as a fine, white to off-white powder that is hygroscopic (moisture-sensitive) and requires careful handling to maintain stability and potency.

Application

• Pharmaceutical Active Ingredient (API): Core component in the manufacture of injectable antibiotic formulations for hospital use.
• Ophthalmic Preparations: Key ingredient in eye drops and ointments for treating bacterial conjunctivitis and other ocular infections.
• Inhalation Solutions: Used in nebulizer solutions for the management of chronic pulmonary infections in conditions like cystic fibrosis.
• Veterinary Medicine: Formulated into treatments for bacterial infections in livestock and companion animals.
• Research & Development: Serves as a reference standard and raw material in microbiological and pharmacological research.
• Topical Formulations: Incorporated into creams and gels for localized skin and wound infections.

Basic Information

Product Name	Tobramycin Sulfate
CAS No.	79645-27-5
Molecular Formula	C18H37N5O9 · xH2SO4
Molecular Weight	467.52 g/mol (for Tobramycin base); variable with sulfate salt
Synonyms	Tobramycin Sulphate; Nebcin (brand name); TOBI (brand name for inhalation); (2S,3R,4S,5S,6R)-4-Amino-2-{[(1S,2S,3R,4S,6R)-4,6-diamino-3-{[(2S,3R,4S,5R)-3,5-dihydroxy-5-methyl-4-(methylamino)oxan-2-yl]oxy}-2-hydroxycyclohexyl]oxy}-6-(hydroxymethyl)oxane-3,5-diol sulfate; O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine sulfate
EINECS	Contact for details

Quality Control

Our Tobramycin Sulfate is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is tested against relevant pharmacopoeial specifications such as USP, EP, and BP monographs. Our comprehensive quality control includes testing for identity, potency, purity, and specific impurities like related substances and residual solvents. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and assay. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
pH (1% solution)	3.5 - 6.0
Assay (HPLC, anhydrous basis)	95.0% - 102.0%
Water Content (KF)	≤ 8.0%
Related Substances (HPLC)	Individual impurity ≤ 2.0%; Total impurities ≤ 5.0%
Sulfate Content (Titration)	18.0% - 24.0%
Residue on Ignition	≤ 1.0%
Bacterial Endotoxins	< 1.0 EU/mg (for injectable grade)
Sterility (where applicable)	Conforms to test

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