Meprobamate API Manufacturer in India

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

Meprobamate API

Meprobamate is a carbamate-class central nervous system (CNS) depressant with anxiolytic and sedative properties. It has historically been used for the short-term management of anxiety and tension and as a skeletal muscle relaxant.

Meprobamate is a synthetic pharmaceutical compound that acts primarily through modulation of inhibitory neurotransmission in the CNS.

Meprobamate API Manufacturer in India

Meprobamate is a specialized CNS pharmaceutical API used in pharmaceutical research and formulation development. Because it is a centrally acting compound, its manufacture and handling require appropriate quality and regulatory controls.

Key quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and stability characteristics, according to the applicable API specification.

Chemical Information

CAS Number: 57-53-4
Molecular Formula: C9H18N2O4
Molecular Weight: 218.25 g/mol
Chemical Name: Meprobamate
Drug Class: Carbamate
Therapeutic Class: Anxiolytic / Sedative / Skeletal Muscle Relaxant
Therapeutic Area: CNS / Psychiatry
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Meprobamate is a CNS depressant that enhances inhibitory neuronal activity. Its pharmacological effects are associated with reduced neuronal excitability and CNS depression.

Its activity is broadly associated with:

  • Reduction of CNS neuronal excitability
  • Anxiolytic effects
  • Sedative effects
  • Skeletal muscle relaxation
  • Modulation of inhibitory neurotransmission

Pharmaceutical Applications

Meprobamate API has historically been associated with:

  • Anxiety and tension
  • Short-term anxiolytic therapy
  • Sedative applications
  • Skeletal muscle relaxation
  • CNS pharmacology research
  • Pharmaceutical formulation development

Dosage Form Applications

Historically, Meprobamate has been formulated as:

  • Oral tablets
  • Oral capsules
  • Other oral pharmaceutical preparations

Its availability and approved applications vary by country because of regulatory restrictions associated with centrally acting sedative/anxiolytic medicines.

Physical Characteristics

Meprobamate is generally described as a white crystalline solid. Its physical and solid-state characteristics should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Meprobamate API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of appropriate intermediates
  3. Controlled chemical synthesis
  4. Carbamate formation
  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 Meprobamate API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Melting range
  • Particle-size distribution where applicable
  • Stability testing

Storage

Store Meprobamate API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Pharmaceutical Research

Meprobamate is relevant to research involving:

  • CNS depressants
  • Anxiolytic agents
  • Sedative pharmacology
  • Skeletal muscle relaxants
  • Inhibitory neurotransmission
  • CNS drug development
  • Historical anxiolytic pharmacology

Meprobamate API Summary

Meprobamate is a carbamate-class CNS depressant with anxiolytic, sedative and muscle-relaxant properties. It has CAS Number 57-53-4, molecular formula C9H18N2O4, and molecular weight 218.25 g/mol. It has historically been used for anxiety and tension and in skeletal muscle-relaxant 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 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 2.0%
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