Lincomycin Hydrochloride API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Lincomycin Hydrochloride API

Lincomycin Hydrochloride is the hydrochloride salt of lincomycin, a lincosamide antibiotic produced by Streptomyces lincolnensis. It exhibits antibacterial activity primarily by inhibiting bacterial protein synthesis through binding to the 50S subunit of bacterial ribosomes.

Lincomycin Hydrochloride is used in pharmaceutical formulations for the treatment of susceptible Gram-positive bacterial infections and is particularly associated with infections caused by susceptible staphylococci and streptococci.

Lincomycin Hydrochloride API Manufacturer in India

Lincomycin Hydrochloride is a specialized antibiotic pharmaceutical API requiring controlled fermentation or biotechnological production, purification, salt formation and comprehensive quality testing.

Important quality attributes include identity, assay, related substances, water content, pH, specific optical rotation, residual solvents and microbiological quality.

Chemical Information

CAS Number: 859-18-7
Molecular Formula: C18H35ClN2O6S
Molecular Weight: 443.00 g/mol
Drug Class: Antibiotic
Pharmacological Class: Lincosamide Antibiotic
Therapeutic Class: Antibacterial Agent
Therapeutic Area: Infectious Diseases
Molecule Type: Natural Product / Antibiotic

Mechanism of Action

Lincomycin binds to the 50S ribosomal subunit of susceptible bacteria and inhibits bacterial protein synthesis.

This interference with protein synthesis suppresses bacterial growth and produces primarily bacteriostatic activity, although activity may be bactericidal against certain organisms at appropriate concentrations.

Pharmaceutical Applications

Lincomycin Hydrochloride is used for susceptible bacterial infections, including infections associated with:

  • Staphylococci
  • Streptococci
  • Other susceptible Gram-positive organisms
  • Respiratory tract infections
  • Skin and soft-tissue infections
  • Bone and joint infections

Use depends on the susceptibility of the causative organism and applicable prescribing information.

Antibiotic Characteristics

Lincomycin belongs to the lincosamide class of antibiotics. It is structurally distinct from β-lactam antibiotics and acts primarily by interfering with bacterial ribosomal protein synthesis.

Manufacturing Process

Lincomycin Hydrochloride is generally produced using a controlled fermentation-based manufacturing process, followed by downstream purification and conversion to the hydrochloride salt.

A typical process may involve:

  1. Preparation of qualified production culture
  2. Controlled microbial fermentation
  3. Harvesting of fermentation broth
  4. Separation and clarification
  5. Extraction or adsorption
  6. Purification
  7. Concentration
  8. Hydrochloride salt formation
  9. Crystallization
  10. Filtration and drying
  11. Milling where required
  12. Final analytical and microbiological testing
  13. GMP-compliant packaging

Quality Control Testing

Typical Lincomycin Hydrochloride API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water content
  • pH
  • Specific optical rotation
  • Residue on ignition
  • Residual solvents
  • Elemental impurities
  • Microbiological quality
  • Stability testing

Storage

Store Lincomycin Hydrochloride in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow the approved API specification and validated stability data.

Pharmaceutical Research

Lincomycin Hydrochloride is relevant to research involving:

  • Lincosamide antibiotics
  • Bacterial protein synthesis
  • 50S ribosomal subunit
  • Gram-positive bacteria
  • Antibacterial drug development
  • Microbial fermentation
  • Antibiotic susceptibility
  • Infectious disease research
  • Pharmaceutical microbiology

Lincomycin Hydrochloride API Summary

Lincomycin Hydrochloride is a lincosamide antibiotic API with CAS Number 859-18-7, molecular formula C18H35ClN2O6S, and molecular weight 443.00 g/mol. It acts primarily by binding to the bacterial 50S ribosomal subunit and inhibiting protein synthesis.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 85.0% on anhydrous basis
Loss on Drying NMT 5.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 3.0 – 5.5
Individual Impurity NMT 2.0%
Total Impurities NMT 5.0%
Water Content NMT 5.0%
Get Bulk Quote via WhatsApp