Viomycin API Manufacturer and Supplier in India

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Viomycin API Manufacturer and Supplier in India

Viomycin is a naturally occurring peptide antibiotic belonging to the tuberactinomycin group of antimicrobial compounds. It is an important pharmaceutical active ingredient historically used in the treatment of tuberculosis, particularly in cases involving drug-resistant Mycobacterium tuberculosis. Viomycin is also known by the names Florimycin, Viocin and Tuberactinomycin B.

Viomycin has the molecular formula C25H43N13O10 and a molecular weight of approximately 685.7 g/mol for the free compound. The commonly referenced pharmaceutical form is Viomycin Sulfate, with CAS Number 32988-50-4. The sulfate material can occur with variable hydration/solvation, so molecular weight values for the sulfate preparation may vary depending on the declared composition.

Viomycin is a peptide antibiotic with a highly polar structure and multiple amino and hydroxyl functionalities. It is highly water soluble compared with many conventional small-molecule APIs and is practically insoluble in most organic solvents.

Pharmaceutical and Therapeutic Profile

Viomycin belongs to the tuberactinomycin family of antibiotics. It acts primarily against susceptible mycobacteria and has historically been used as an injectable anti-tuberculosis drug.

Its antibacterial activity is associated with interference with bacterial protein synthesis. Viomycin binds to bacterial ribosomal components and interferes with accurate translation, ultimately inhibiting the production of essential proteins required for bacterial growth.

The compound has historically been particularly relevant to Mycobacterium tuberculosis and was developed for use when resistance to other anti-tuberculosis agents limited treatment options.

Mechanism of Action

Viomycin acts on the bacterial ribosome and interferes with protein synthesis.

The antibiotic interacts with the bacterial ribosomal machinery and affects translation accuracy. This prevents normal synthesis of essential bacterial proteins and contributes to inhibition of bacterial growth.

Viomycin is structurally related to other tuberactinomycin antibiotics such as capreomycin, although the compounds have distinct chemical structures and pharmacological characteristics.

Chemical Characteristics

Viomycin is a complex peptide antibiotic rather than a conventional synthetic small molecule. It contains multiple amino, carbonyl and hydroxyl functional groups that contribute to its high polarity.

Important characteristics include:

  • Complex peptide antibiotic structure
  • Multiple amino groups
  • Multiple hydroxyl groups
  • Strongly polar molecular structure
  • High aqueous solubility
  • Very low solubility in most organic solvents
  • Optical activity
  • Hygroscopic characteristics

Historical physicochemical studies reported that Viomycin Sulfate is optically active and has a negative specific rotation. The reported value varies depending on hydration state, concentration, solvent and drying conditions.

Pharmaceutical Applications

Viomycin API is primarily associated with anti-tuberculosis pharmaceutical applications.

Potential applications include:

  • Anti-tuberculosis pharmaceutical formulations
  • Tuberculosis research
  • Drug-resistant tuberculosis research
  • Mycobacterial infection research
  • Injectable pharmaceutical development
  • Antibiotic research
  • Pharmaceutical API development

Viomycin has historically been administered by injection because of its pharmacological and physicochemical characteristics.

Antimicrobial Activity

Viomycin exhibits antibacterial activity primarily against Mycobacterium tuberculosis and related susceptible mycobacteria.

The compound has historically been used as a second-line anti-tuberculosis antibiotic. However, its clinical use has been limited because of significant toxicity concerns, including renal and vestibular adverse effects.

Analytical Characterization

Because Viomycin is a complex peptide antibiotic, its quality assessment differs from that of conventional small-molecule APIs.

Important analytical approaches may include:

  • HPLC
  • UV spectroscopy
  • IR spectroscopy
  • Mass spectrometry
  • Specific rotation
  • pH determination
  • Water determination
  • Residue on ignition
  • Microbiological potency
  • Related-substance analysis

Historical pharmacopoeial and regulatory standards have also used microbiological potency testing for Viomycin.

Specific Rotation

Viomycin is optically active. Historical studies reported a specific rotation of approximately −32° for air-dried Viomycin Sulfate in a 1% aqueous solution and approximately −40.6° after vacuum drying under specified conditions.

Because the observed rotation depends strongly on hydration and test conditions, a single numerical value should not be inserted into the CMS without matching the exact applicable monograph method.

Solubility

Viomycin Sulfate is highly soluble in water and is essentially insoluble or very poorly soluble in most organic solvents.

This high aqueous solubility is consistent with its highly polar peptide structure.

Storage and Handling

Viomycin Sulfate should be stored in tightly closed pharmaceutical-grade containers and protected from excessive moisture and unsuitable environmental conditions.

Because Viomycin Sulfate can contain water associated with the material, moisture and water content should be controlled according to the applicable pharmaceutical specification.

Viomycin API for Pharmaceutical Manufacturing

Viomycin API is relevant to pharmaceutical companies, research organizations and qualified manufacturers working with anti-tuberculosis and mycobacterial pharmaceutical products.

Swapnroop Drugs & Pharmaceuticals provides Viomycin API for pharmaceutical research, formulation development and bulk API requirements, subject to applicable quality and regulatory specifications.

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 0.1%
Water Content NMT 4.5%
Specific Rotation Approximately −32° to −40.6°
Melting Point Approximately 252°C with decomposition
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