Clofoctol API Manufacturer in India

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

Clofoctol API

Clofoctol is a synthetic antibacterial active pharmaceutical ingredient belonging to the phenol-derived antimicrobial class. It has been used as a local antibacterial agent, particularly in pharmaceutical preparations intended for the treatment of infections of the respiratory tract.

Clofoctol is chemically identified as 2,2'-Methylenebis(4-chlorophenol). It has the molecular formula C₁₃H₁₀Cl₂O₂, molecular weight 269.12 g/mol, and CAS number 37693-01-9.

Clofoctol has demonstrated antibacterial activity against susceptible Gram-positive microorganisms. Its antimicrobial activity is associated with disruption of bacterial cellular functions and membrane integrity.

Pharmaceutical Applications

Clofoctol has historically been used in pharmaceutical preparations for localized treatment of bacterial infections, particularly infections involving the respiratory tract.

Its pharmaceutical applications have included:

  • Upper respiratory tract infections
  • Localized bacterial infections
  • Respiratory tract infections
  • Throat infections
  • Antibacterial formulations
  • Local antimicrobial preparations

The actual indication depends on the finished dosage form, strength, route of administration and applicable regulatory approval.

Key Product Features

  • Synthetic antibacterial API
  • Phenolic antimicrobial compound
  • Chlorinated phenol derivative
  • Suitable for pharmaceutical formulation development
  • Active against susceptible Gram-positive bacteria
  • Defined chemical composition
  • Suitable for pharmaceutical-quality manufacturing

Pharmacological Activity

Clofoctol is a phenolic antibacterial compound. Its antimicrobial activity is primarily associated with interaction with bacterial cell membranes and interference with essential cellular processes.

The compound can affect bacterial membrane function, resulting in disruption of cellular integrity and inhibition of bacterial growth.

Its pharmacological properties include:

  • Antibacterial activity
  • Antimicrobial activity
  • Activity against susceptible Gram-positive organisms
  • Local anti-infective action

Chemical and Physical Characteristics

Clofoctol is a chlorinated bisphenolic compound containing two phenolic hydroxyl groups.

Chemical Identity

Product Name: Clofoctol

Chemical Name: 2,2'-Methylenebis(4-chlorophenol)

CAS Number: 37693-01-9

Molecular Formula: C₁₃H₁₀Cl₂O₂

Molecular Weight: 269.12 g/mol

Chemical Class: Chlorinated phenol

Pharmacological Class: Antibacterial

Physical Form: Solid

Appearance: White to almost-white crystalline powder

Water Solubility: Practically insoluble in water

Clofoctol for Pharmaceutical Manufacturing

Clofoctol API can be used as an active ingredient in pharmaceutical development and manufacturing of antibacterial formulations.

Its physicochemical characteristics make appropriate control of particle properties, purity, related substances and formulation compatibility important during pharmaceutical development.

Quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Loss on drying
  • Residue on ignition
  • Heavy metals / elemental impurities
  • Water content
  • Melting point
  • Appearance
  • Solubility

Each commercial batch should be released against the manufacturer's approved specification and supported by a batch-specific Certificate of Analysis.

Quality and Documentation

For pharmaceutical customers, Clofoctol API can be supported with appropriate technical and quality documentation, depending on the supplied grade and regulatory requirements.

Typical documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Technical Data Sheet (TDS)
  • Safety Data Sheet (SDS)
  • Batch analytical data
  • Packaging information
  • Storage information
  • Stability information, where available
  • Regulatory documentation, where applicable

Packaging and Storage

Clofoctol should be handled and stored according to the applicable API specification.

Recommended handling considerations include:

  • Keep the container tightly closed.
  • Protect from moisture.
  • Protect from excessive heat and direct light.
  • Store in a cool, dry and well-ventilated area.
  • Follow the manufacturer's approved storage conditions.
  • Handle using appropriate pharmaceutical material-handling procedures.

Why Choose Pharmaceutical-Grade Clofoctol?

Consistent API quality is important for reproducible pharmaceutical manufacturing. Clofoctol intended for pharmaceutical applications should therefore undergo appropriate identity, purity and assay testing.

Important quality characteristics include:

Chemical identity: Confirms the API is Clofoctol.

Assay purity: Ensures consistent active-ingredient content.

Related substances: Controls chemically related impurities.

Physical characteristics: Supports consistent formulation processing.

Documentation: Provides traceability and quality assurance.

Clofoctol API Manufacturer & Supplier

Clofoctol is a specialized antibacterial active pharmaceutical ingredient used in pharmaceutical applications. Pharmaceutical-grade material can be supplied to formulation manufacturers and pharmaceutical companies requiring Clofoctol for product development or commercial manufacturing.

For Clofoctol API specifications, CoA, technical documentation, packaging options and commercial supply information, customers can contact the supplier for product-specific details.

Detailed Specifications

Parameter Specification
Identification IR absorption conforms to Clofoctol reference standard
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 1.0%
Water Content NMT 1.0%
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