Moclobemide API Manufacturer in India

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Moclobemide API

Moclobemide is a reversible inhibitor of monoamine oxidase-A (RIMA) and belongs to the benzamide class of pharmaceutical compounds. It increases the availability of monoamine neurotransmitters, including serotonin, norepinephrine and dopamine, by reversibly inhibiting their metabolism through monoamine oxidase-A. It is primarily associated with the treatment of major depressive disorder and depressive symptoms.

Moclobemide is a specialized central nervous system (CNS) pharmaceutical API used in the development and manufacture of antidepressant formulations.

Moclobemide API Manufacturer in India

Moclobemide is a synthetic pharmaceutical compound with applications in antidepressant and neuropsychiatric drug development. Its API quality assessment includes identity, assay, related substances, water content, residual solvents and other applicable pharmaceutical quality attributes.

Chemical Information

CAS Number: 71320-77-9
Molecular Formula: C13H17ClN2O2
Molecular Weight: 268.74 g/mol
IUPAC Name: 4-chloro-N-(2-morpholin-4-ylethyl)benzamide
Drug Class: Reversible Monoamine Oxidase-A Inhibitor
Therapeutic Class: Antidepressant
Therapeutic Area: Psychiatry / CNS
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Moclobemide selectively and reversibly inhibits monoamine oxidase-A (MAO-A). MAO-A is involved in the metabolism of neurotransmitters such as serotonin, norepinephrine and dopamine.

By inhibiting MAO-A, moclobemide increases the availability of these monoamines in the central nervous system, supporting its antidepressant pharmacological activity.

Pharmaceutical Applications

Moclobemide API is associated with:

  • Major depressive disorder
  • Depression
  • Antidepressant drug development
  • MAO-A inhibitor research
  • CNS pharmacology
  • Neuropsychiatric pharmaceutical research

Dosage Form Applications

Moclobemide has been developed primarily for oral pharmaceutical formulations, including tablets.

Physical Characteristics

Moclobemide is a solid crystalline compound. PubChem reports crystals obtained from isopropanol, with reported melting-point values of approximately 132–137 °C from referenced sources.

Manufacturing Process

A controlled Moclobemide API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of substituted benzamide intermediates
  3. Controlled amide synthesis
  4. Introduction of the morpholine-containing side chain
  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

Moclobemide API quality evaluation may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Melting range
  • Stability testing

Storage

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

Pharmaceutical Research

Moclobemide is relevant to research involving:

  • Monoamine oxidase-A
  • Reversible MAO inhibitors
  • Serotonin metabolism
  • Norepinephrine metabolism
  • Dopamine metabolism
  • Antidepressant pharmacology
  • CNS drug development
  • Neuropsychiatric research

Moclobemide API Summary

Moclobemide is a reversible MAO-A inhibitor and antidepressant compound with CAS Number 71320-77-9, molecular formula C13H17ClN2O2, and molecular weight 268.74 g/mol. Its pharmacological activity is based on reversible inhibition of monoamine oxidase-A.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 0.50%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 10 ppm
pH (1% Solution) 4.5–6.5
Individual Impurity NMT 0.50%
Water Content NMT 0.50%
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