Methoxyflurane API Manufacturer in India

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Methoxyflurane API

Methoxyflurane is a halogenated ether inhalation anesthetic and analgesic compound. It is a clear, colorless liquid with a characteristic fruity odor. Methoxyflurane has historically been used as an inhalational anesthetic and is also used in some markets at low doses for short-term analgesia.

Methoxyflurane API Manufacturer in India

Methoxyflurane is a specialized inhalation anesthetic pharmaceutical API. Its quality is particularly important because it is a volatile liquid and is subject to specific pharmacopeial requirements for purity, acidity, water and nonvolatile residue.

The current USP monograph defines Methoxyflurane as containing NLT 99.9% and NMT 100.0% of C₃H₄Cl₂F₂O.

Chemical Information

CAS Number: 76-38-0
Molecular Formula: C₃H₄Cl₂F₂O
Molecular Weight: 164.97 g/mol
IUPAC Name: 2,2-Dichloro-1,1-difluoro-1-methoxyethane
Drug Class: Halogenated Ether
Therapeutic Class: Inhalation Anesthetic / Analgesic
Therapeutic Area: Anesthesiology / Pain Management
Molecule Type: Synthetic Small Molecule

NIST reports a molecular weight of 164.966 g/mol, while the USP monograph uses 164.97.

Mechanism of Action

Methoxyflurane produces CNS depression through effects on neuronal signaling associated with general anesthetic activity. At higher historical doses it produces anesthesia, while lower-dose inhalation has been used for analgesia.

Pharmaceutical Applications

Methoxyflurane is associated with:

  • Inhalation anesthesia
  • Short-term analgesia
  • Emergency pain management
  • Anesthesiology research
  • Pharmaceutical development of inhalational anesthetics

Physical Characteristics

Methoxyflurane is a clear, colorless liquid with a fruity odor. Its reported melting point is approximately −35°C, while its boiling point is approximately 105°C at atmospheric pressure.

The USP specifies a specific gravity of 1.420–1.425.

Manufacturing Process

A controlled Methoxyflurane manufacturing process may include:

  1. Qualification of starting materials
  2. Controlled synthesis of the halogenated ether
  3. Purification
  4. Removal of volatile and nonvolatile impurities
  5. Distillation
  6. Stabilizer adjustment where applicable
  7. Final quality-control testing
  8. Filling into suitable light-resistant containers
  9. Pharmaceutical-grade packaging

Quality Control Testing

USP testing specifically includes:

  • Identification
  • Specific gravity
  • Acidity
  • Water
  • Limit of nonvolatile residue
  • Assay by gas chromatography

The USP assay requirement is 99.9%–100.0%. Water is limited to NMT 0.1%, and nonvolatile residue must not exceed 1 mg from a 50 mL sample.

Storage

The USP specifies storage in tight, light-resistant containers and avoidance of excessive heat.

Pharmaceutical Research

Methoxyflurane is relevant to research involving:

  • Inhalational anesthetics
  • Analgesic pharmacology
  • Volatile anesthetic agents
  • CNS pharmacology
  • Emergency pain management
  • Anesthesiology
  • Pharmaceutical formulation development

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 99.9%–100.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.2%
Heavy Metals NMT 10 ppm
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 0.5%
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