Tobramycin Sulphate USP Amaris Chemicals
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PHARMACEUTICAL GRADE USP GRADE

Tobramycin Sulphate

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Tobramycin Sulphate USP is a purified, water-soluble sulfate salt of tobramycin, an aminoglycoside antibiotic. It exhibits potent bactericidal activity against a broad spectrum of aerobic Gram-negative bacteria, including Pseudomonas aeruginosa, and certain Gram-positive bacteria. This pharmaceutical-grade compound is primarily used to treat severe infections such as respiratory tract infections, urinary tract infections, and septicemia. Tobramycin Sulphate USP is commonly formulated for injectable, inhalation, and ophthalmic applications, ensuring effective systemic and localized antimicrobial therapy.

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Description

Tobramycin Sulphate

Primary Uses

  1. Pharmaceutical Industry
  • Injectable Antibiotic Formulations: Treatment of serious bacterial infections including pneumonia, septicemia, and intra-abdominal infections.
  • Inhalation Therapy: Management of chronic Pseudomonas aeruginosa lung infections, especially in cystic fibrosis patients.
  • Ophthalmic Preparations: Treatment of bacterial conjunctivitis, keratitis, and other eye infections.
  • Topical Antibiotics: Used in creams and ointments for skin infections and burns.

Secondary Uses

  1. Veterinary Medicine
  • Used for treating bacterial infections in animals, particularly respiratory and urinary tract infections.
  1. Research & Development
  • Employed in pharmaceutical R&D for antibiotic efficacy studies and formulation development.
  1. Combination Therapies
  • Used in combination with other antibiotics to prevent resistance and enhance antimicrobial spectrum.
KEY PRODUCT FEATURES

1. Basic Identification Attributes

  • Chemical Name (IUPAC): (2S,3R,4S,5S,6R)-4,5-diamino-2-(aminomethyl)-6-(methylamino)oxane-3,5-diol sulfate (2:1)
  • Common/Trade Name: Tobramycin Sulphate USP
  • CAS Number: 32986-56-4
  • HS Code: 2941.10.00
  • Synonyms: Tobramycin sulfate, Tobramycin salt

2. Physical & Chemical Properties

  • Physical State: White to off-white crystalline powder
  • Color & Odor: White; odorless to slight ammoniacal odor
  • Melting Point: Approximately 218-223 °C (decomposes)
  • Solubility: Highly soluble in water; practically insoluble in alcohol and organic solvents
  • pH of Solution: Typically 5.5 - 7.0 (1% aqueous solution)
  • Density: Approx. 1.5 g/cm³

3. Safety & Hazard Attributes

  • GHS Classification: 
    • Not classified as hazardous under normal handling, but antibiotic powders may cause sensitization.
  • Toxicity: Nephrotoxic and ototoxic at high doses or prolonged use; requires therapeutic monitoring.
  • Exposure Limits: No specific occupational exposure limits; use safe handling practices to avoid inhalation or skin contact.

4. Storage & Handling Attributes

  • Storage Conditions: Store in a cool, dry place below 25 °C, protected from light and moisture.
  • Container Type: Sealed, moisture-proof containers or packaging.
  • Shelf Life: Typically 24-36 months under proper storage.
  • Handling Precautions: Use gloves and dust masks; avoid inhalation and prolonged skin contact.

5. Regulatory & Compliance Attributes

  • Complies with USP standards for identity, purity, potency, and quality.
  • Manufactured under Good Manufacturing Practices (GMP).
  • Listed in major pharmacopeias including USP, BP, EP.
  • Complies with FDA and international drug regulatory requirements.
  • Suitable for use in human and veterinary medicinal products.

6. Environmental & Health Impact

  • Biodegradability: Readily biodegradable under aerobic conditions.
  • Ecotoxicity: Moderate toxicity to aquatic organisms; avoid environmental release.
  • Bioaccumulation: Not significant.
SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

  • PPE Required: Gloves, protective clothing, dust masks or respirators recommended.
  • Handling Guidelines: Avoid dust generation; work in well-ventilated areas or under fume hoods.
  • Storage Measures: Keep containers tightly sealed to prevent moisture ingress.

First Aid Measures

  • Inhalation: Move to fresh air; seek medical attention if respiratory irritation occurs.
  • Skin Contact: Wash affected area thoroughly with soap and water.
  • Eye Contact: Rinse immediately with plenty of water for at least 15 minutes; seek medical advice if irritation persists.
  • Ingestion: Rinse mouth; obtain immediate medical attention.

Firefighting Measures

  • Fire Hazards: Not combustible but may decompose under fire to emit toxic fumes.
  • Extinguishing Media: Use water spray, foam, dry chemical, or CO₂ extinguishers.
  • Hazardous Combustion Products: May produce nitrogen oxides (NOx), sulfur oxides (SOx), and other toxic gases.

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