Tobramycin Sulfate API Manufacturer and Supplier in India | CAS 49842-07-1 | Swapnroop Pharma

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Tobramycin Sulfate API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tobramycin Sulfate API in India, supporting pharmaceutical formulation, generic drug manufacturing, bulk API procurement and export requirements.

Tobramycin Sulfate is the sulfate salt of tobramycin, an aminoglycoside antibacterial agent. Tobramycin acts primarily by binding to the bacterial 30S ribosomal subunit, interfering with protein synthesis and producing antibacterial activity.

Tobramycin Sulfate is identified by CAS 49842-07-1 in current PubChem records, while 79645-27-5 is also encountered as a legacy/deprecated CAS identifier.

Tobramycin Sulfate API Overview

Tobramycin Sulfate belongs to the aminoglycoside antibiotic class and is used in pharmaceutical products intended for the treatment of susceptible bacterial infections.

The sulfate salt is commonly represented as:

(C₁₈H₃₇N₅O₉)₂ · 5H₂SO₄

with a molecular weight of approximately 1425.4 g/mol.

The API is described as a white to almost white powder and is water soluble. Tobramycin Sulfate is hygroscopic and requires appropriate moisture-protective packaging.

Chemical and Pharmaceutical Profile

ParameterDetails
Product NameTobramycin Sulfate
CAS Number49842-07-1
Legacy/Alternate CAS79645-27-5
Molecular Formula(C₁₈H₃₇N₅O₉)₂ · 5H₂SO₄
Molecular Weight1425.4 g/mol
Parent APITobramycin
Parent CAS32986-56-4
API CategoryAminoglycoside Antibiotic
Therapeutic CategoryAntibacterial
Physical FormWhite to almost white powder
SolubilitySoluble in water; difficult to dissolve in ethanol; practically insoluble in chloroform and ether

PubChem reports the molecular formula C₃₆H₈₄N₁₀O₃₈S₅, molecular weight 1425.4 g/mol, and CAS 49842-07-1 for Tobramycin Sulfate.

Mechanism of Action

Tobramycin is an aminoglycoside antibiotic that binds to the bacterial 30S ribosomal subunit. This interferes with initiation and accuracy of bacterial protein synthesis, including misreading of mRNA, ultimately contributing to bacterial cell death.

Pharmaceutical Applications

Tobramycin Sulfate API is used in the development and manufacture of pharmaceutical products for susceptible bacterial infections, particularly infections involving susceptible Gram-negative organisms.

It is used in pharmaceutical preparations including:

  • Injectable antibacterial formulations
  • Ophthalmic formulations
  • Inhalation formulations
  • Other dosage forms containing tobramycin
  • Pharmaceutical formulation development
  • Generic antibacterial drug manufacturing

Tobramycin sulfate is described in FDA labeling as a water-soluble aminoglycoside antibiotic derived from Streptomyces tenebrarius.

Tobramycin Sulfate API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals supplies Tobramycin Sulfate API for pharmaceutical manufacturers and formulation companies requiring an aminoglycoside antibiotic API.

As a Tobramycin Sulfate API supplier in India, Swapnroop supports bulk procurement, formulation manufacturing, development requirements and international pharmaceutical supply.

Supply can be arranged according to agreed specifications, quantity, packaging and applicable regulatory documentation.

Bulk Tobramycin Sulfate API Supply

Tobramycin Sulfate API can be supplied for:

  • Bulk pharmaceutical manufacturing
  • Generic formulation development
  • Injectable formulation development
  • Ophthalmic formulation development
  • Inhalation formulation development
  • Contract manufacturing
  • Pharmaceutical R&D
  • Domestic API procurement
  • International API export requirements

Quality and Product Characterization

Tobramycin Sulfate has a USP monograph with a potency specification of 634–739 µg/mg of tobramycin, determined by an HPLC-based derivatization assay. The USP specification also includes pH 6.0–8.0 at 40 mg/mL and residue on ignition NMT 1.0%. The current USP revision specifies water NMT 7.0%.

Where Tobramycin Sulfate is intended for injectable manufacture, USP additionally addresses bacterial endotoxins and sterility requirements according to the applicable labeling/use.

Packaging and Storage

Tobramycin Sulfate should be protected from moisture because the material is hygroscopic. The USP specifies preservation in tight containers.

Storage and packaging should follow the applicable approved specification, stability data and customer requirements.

Documentation

Depending on the supply requirement, documentation may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS)
  • Batch documentation
  • Manufacturing documentation
  • Regulatory documentation, where applicable
  • BSE/TSE-related documentation, where applicable
  • Export documentation

Why Choose Swapnroop as Tobramycin Sulfate API Supplier?

  • Pharmaceutical API manufacturing and supply expertise
  • Tobramycin Sulfate bulk API supply
  • Specification-driven manufacturing
  • Support for pharmaceutical formulation requirements
  • Domestic and international supply capabilities
  • Regulatory and quality documentation support
  • Customer-specific packaging options
  • Export-oriented pharmaceutical API supply

Tobramycin Sulfate API for Pharmaceutical Manufacturing

Tobramycin Sulfate is an established aminoglycoside antibacterial API with defined pharmacopoeial potency and quality requirements. Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Tobramycin Sulfate API in India for formulation development, commercial manufacturing, bulk procurement and export requirements.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Residue on Ignition NMT 1.0%
pH (1% Solution) 6.0–8.0
Individual Impurity NMT 1.0%
Water Content NMT 7.0%
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