Isoflurane API | Inhalation Anesthetic API Manufacturer in India

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Isoflurane API

Isoflurane is a halogenated volatile inhalational anesthetic used for the induction and maintenance of general anesthesia. It is a fluorinated ether supplied as a volatile liquid for administration through an anesthesia vaporizer.

Isoflurane produces reversible central nervous system depression and is widely used in operating-room and anesthetic settings.

Isoflurane API Manufacturer in India

Isoflurane is a specialized volatile anesthetic pharmaceutical ingredient requiring controlled manufacturing, purification and packaging because of its volatility and sensitivity to contamination.

Quality control focuses on identity, assay, related substances, water content, acidity, non-volatile residue and other physicochemical characteristics relevant to inhalational anesthetic quality.

Chemical Information

CAS Number: 26675-46-7
Molecular Formula: C3H2ClF5O
Molecular Weight: 184.49 g/mol
Drug Class: General Anesthetic
Pharmacological Class: Volatile Inhalational Anesthetic
Therapeutic Class: Anesthetic Agent
Therapeutic Area: Anesthesiology

Mechanism of Action

Isoflurane produces general anesthesia by acting on multiple molecular targets within the central nervous system. Its effects involve modulation of several ion channels and neurotransmitter systems, resulting in reduced neuronal excitability and reversible loss of consciousness.

The clinical effects include:

  • Loss of consciousness
  • Amnesia
  • Immobility
  • Skeletal-muscle relaxation
  • Reduction of responses to surgical stimulation

Pharmaceutical Applications

Isoflurane is primarily used for:

  • Induction of general anesthesia
  • Maintenance of general anesthesia
  • Surgical anesthesia
  • Inpatient and outpatient operative procedures where inhalational anesthesia is appropriate

Physical and Chemical Properties

Isoflurane is a clear, colorless, volatile liquid with a characteristic ether-like odor. It is nonflammable under ordinary clinical conditions and has a relatively low blood-gas solubility, supporting comparatively rapid changes in anesthetic depth.

Manufacturing Process

Typical production may involve:

  1. Controlled synthesis of fluorinated ether intermediates
  2. Reaction and purification
  3. Removal of reaction by-products
  4. Fractional distillation
  5. Final purification
  6. Quality-control testing
  7. Filling into suitable sealed containers
  8. Controlled packaging and storage

Quality and Analytical Testing

Isoflurane quality evaluation may include:

  • Identification by infrared spectroscopy
  • Assay by chromatographic analysis
  • Related volatile impurities
  • Water content
  • Acidity
  • Non-volatile residue
  • Halogenated impurity profile
  • Refractive index
  • Specific gravity
  • Stability testing

Storage

Isoflurane should be stored in tightly closed, appropriately labeled containers, protected from excessive heat and direct light. Because it is a volatile anesthetic, appropriate handling and storage controls should be maintained throughout manufacturing and distribution.

Pharmaceutical Research and Development

Isoflurane is relevant to research involving:

  • General anesthesia
  • Volatile anesthetics
  • Inhalational anesthetic pharmacology
  • Anesthesia delivery systems
  • CNS pharmacology
  • Surgical anesthesia
  • Preclinical anesthetic research

Isoflurane API Summary

Isoflurane is a volatile halogenated inhalational anesthetic with CAS Number 26675-46-7, molecular formula C3H2ClF5O, and molecular weight 184.49 g/mol. It is administered through an anesthesia vaporizer for induction and maintenance of general anesthesia.

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%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content ≤0.05%
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