Ibudilast API Manufacturer in India

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

Ibudilast API Manufacturer in India

Ibudilast is a small-molecule pharmaceutical active ingredient belonging to the phosphodiesterase inhibitor class. It has anti-inflammatory and vasodilatory properties and has been investigated and used in pharmaceutical applications involving the nervous system, respiratory system and inflammatory pathways.

Ibudilast has the molecular formula C14H18N2O and a molecular weight of 230.31 g/mol. Its CAS Number is 50847-11-5.

Ibudilast API Overview

Ibudilast is a synthetic compound chemically known as 3-isobutyryl-2-isopropylpyrazolo[1,5-a]pyridine. It has been used as a pharmaceutical agent in Japan and other markets, particularly for bronchial asthma and cerebrovascular disorders.

Ibudilast has also been investigated for its effects on neuroinflammation and glial-cell activity, making it relevant to pharmaceutical research and development.

Mechanism of Action

Ibudilast inhibits several phosphodiesterase enzymes, including PDE3, PDE4, PDE10 and PDE11, with its pharmacological profile also involving modulation of inflammatory signaling.

It has been studied for effects on inflammatory cytokines and glial-cell activation, which has generated interest in neurological and neuroinflammatory research.

Pharmaceutical Applications

Ibudilast API is used in the development and manufacture of:

  • Anti-inflammatory pharmaceutical formulations
  • Respiratory pharmaceutical products
  • Cerebrovascular-related formulations
  • Neurological research products
  • Neuroinflammation research
  • Pharmaceutical research and development

Ibudilast API Manufacturing

Ibudilast is a synthetic pharmaceutical compound manufactured through controlled chemical synthesis followed by purification, crystallization, drying and pharmaceutical quality testing.

Quality control may include identification, assay, related substances, water content, residue on ignition, melting range and residual solvents according to the applicable approved specification.

Physical and Chemical Properties

Ibudilast is generally supplied as a white to off-white crystalline powder. It has limited solubility in water and is soluble in several organic solvents.

Storage

Ibudilast should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.

Quality Documentation

Depending on the intended pharmaceutical application, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • Analytical test report
  • Residual-solvent information
  • Stability information
  • Regulatory documentation

Conclusion

Ibudilast is a synthetic phosphodiesterase inhibitor with anti-inflammatory and vasodilatory properties. Its established pharmaceutical use and continued investigation in neurological and inflammatory research make it a relevant API for pharmaceutical development and research applications.

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 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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