Mecillinam API Manufacturer in India

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

Mecillinam API

Mecillinam is a beta-lactam antibiotic belonging to the amidinopenicillin class. It has a distinctive activity against Gram-negative bacteria, particularly organisms responsible for urinary tract infections.

Mecillinam is commonly administered in its prodrug form, pivmecillinam, which is converted to the active antibiotic mecillinam after administration.

Mecillinam API Manufacturer in India

Mecillinam is a specialized antibacterial pharmaceutical API used in the development and manufacture of antibiotic formulations, particularly products intended for urinary tract infections.

Important quality attributes include identity, assay, related substances, water content, residual solvents, optical purity, elemental impurities and stability characteristics.

Chemical Information

CAS Number: 32887-01-7
Molecular Formula: C15H23N3O3S
Molecular Weight: 325.43 g/mol
Chemical Name: Mecillinam
Synonyms: Amidinocillin, Amdinocillin
Drug Class: Beta-Lactam Antibiotic
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases / Urology
Molecule Type: Semi-Synthetic Small Molecule

Mechanism of Action

Mecillinam is a beta-lactam antibiotic that primarily targets penicillin-binding protein 2 (PBP2) in susceptible Gram-negative bacteria.

It interferes with bacterial cell-wall synthesis, resulting in disruption of bacterial cell-wall integrity and ultimately bacterial cell death.

Its activity includes:

  • Binding to PBP2
  • Inhibition of peptidoglycan synthesis
  • Disruption of bacterial cell-wall formation
  • Bactericidal activity against susceptible organisms

Pharmaceutical Applications

Mecillinam API is used in pharmaceutical development for:

  • Urinary tract infections
  • Uncomplicated urinary tract infections
  • Gram-negative bacterial infections
  • Antibacterial drug development
  • Microbiology research
  • Beta-lactam antibiotic formulations

Antibacterial Applications

Mecillinam has particular activity against several Enterobacterales, including organisms commonly associated with urinary tract infections.

The active drug is particularly relevant to treatment strategies involving Escherichia coli and other susceptible Gram-negative pathogens.

Pivmecillinam Relationship

Mecillinam has limited oral bioavailability when administered directly. Therefore, pivmecillinam, an orally active prodrug, is commonly used to deliver mecillinam systemically.

After absorption, pivmecillinam is hydrolyzed to release active mecillinam.

Dosage Form Applications

Mecillinam is associated with:

  • Oral antibiotic formulations through pivmecillinam
  • Injectable pharmaceutical formulations of the active antibiotic
  • Urinary tract infection treatments
  • Antibacterial drug development

Physical Characteristics

Mecillinam is generally handled as a solid pharmaceutical substance. Its physical appearance, crystalline characteristics, particle size and solid-state properties should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Mecillinam API manufacturing process may involve:

  1. Selection of qualified starting materials
  2. Preparation of beta-lactam intermediates
  3. Controlled introduction of the amidino side chain
  4. Chemical transformation and coupling
  5. Purification
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Milling or sieving where required
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Mecillinam API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Beta-lactam degradation products
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical purity
  • Particle-size distribution
  • Microbial quality where applicable
  • Stability testing

Storage

Store Mecillinam API in a tightly closed container under controlled pharmaceutical storage conditions, protected from moisture, excessive heat and direct light. Because beta-lactam compounds can be sensitive to environmental conditions, validated storage conditions should be followed.

Pharmaceutical Research

Mecillinam is relevant to research involving:

  • Beta-lactam antibiotics
  • Penicillin-binding proteins
  • PBP2
  • Gram-negative bacteria
  • Enterobacterales
  • Escherichia coli
  • Urinary tract infections
  • Antimicrobial resistance
  • Antibacterial drug development

Mecillinam API Summary

Mecillinam is an amidinopenicillin beta-lactam antibiotic with CAS Number 32887-01-7, molecular formula C15H23N3O3S, and molecular weight 325.43 g/mol. It primarily acts against susceptible Gram-negative bacteria by inhibiting bacterial cell-wall synthesis through PBP2.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Get Bulk Quote via WhatsApp