Loxapine API Manufacturer in India

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

Loxapine API

Loxapine is a dibenzoxazepine antipsychotic API belonging to the chemical class of tricyclic antipsychotic agents. It is used in the treatment of schizophrenia and acts primarily through modulation of dopamine and serotonin neurotransmission in the central nervous system.

Loxapine is available in pharmaceutical formulations such as oral capsules and inhalation dosage forms. Its pharmacological activity is associated with antagonism at several neurotransmitter receptors, including dopamine D2 and serotonin 5-HT2 receptors.

Loxapine API Manufacturer in India

Loxapine is a specialized CNS pharmaceutical API used in the manufacture of antipsychotic formulations.

Important quality attributes include identity, assay, related substances, water content, residue on ignition, residual solvents, elemental impurities and particle characteristics.

Chemical Information

CAS Number: 1977-10-2
Molecular Formula: C18H18ClN3O
Molecular Weight: 327.81 g/mol
Chemical Name: 2-chloro-11-(4-methyl-1-piperazinyl)dibenzo[b,f][1,4]oxazepine
Synonyms: Loxapine Base, Loxapine Free Base
Drug Class: Antipsychotic
Therapeutic Class: Antipsychotic Agent
Therapeutic Area: Psychiatry / CNS
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Loxapine exerts its pharmacological effects through interaction with multiple neurotransmitter receptors in the central nervous system.

Its activity includes antagonism of:

  • Dopamine D2 receptors
  • Serotonin 5-HT2 receptors
  • Other dopaminergic and serotonergic receptor subtypes

This receptor activity contributes to its antipsychotic effects and modulation of neurotransmission associated with schizophrenia.

Pharmaceutical Applications

Loxapine API is used in pharmaceutical formulations for:

  • Schizophrenia
  • Psychotic disorders
  • Antipsychotic drug development
  • CNS pharmacology research
  • Dopamine receptor research
  • Serotonin receptor research

Dosage Form Applications

Loxapine may be incorporated into:

  • Oral capsules
  • Oral solid dosage formulations
  • Inhalation formulations

The inhaled formulation of loxapine is designed for rapid systemic delivery through the lungs and has been used for the acute treatment of agitation associated with schizophrenia or bipolar disorder in appropriate clinical settings.

Physical Characteristics

Loxapine is generally described as a white to off-white crystalline solid/powder. Its physicochemical properties support its use as an active ingredient in pharmaceutical dosage forms.

Manufacturing Process

A controlled Loxapine API manufacturing process may involve:

  1. Preparation of qualified starting materials
  2. Synthesis of the dibenzoxazepine intermediate
  3. Introduction of the chloro substituent
  4. Formation of the piperazine-containing intermediate
  5. Controlled coupling/substitution reaction
  6. Purification
  7. Crystallization
  8. Filtration
  9. Drying
  10. Milling, where required
  11. Final analytical testing
  12. GMP-compliant packaging

Quality Control Testing

Typical Loxapine API testing may include:

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

Storage

Store Loxapine API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow the manufacturer's validated stability data.

Pharmaceutical Research

Loxapine is relevant to research involving:

  • Antipsychotic pharmacology
  • Dopamine D2 receptors
  • Serotonin 5-HT2 receptors
  • Schizophrenia
  • CNS drug development
  • Psychopharmacology
  • Neurotransmitter receptor research
  • Antipsychotic formulations

Loxapine API Summary

Loxapine is a dibenzoxazepine antipsychotic API with CAS Number 1977-10-2, molecular formula C18H18ClN3O, and molecular weight 327.81 g/mol. It acts on multiple neurotransmitter receptor systems, particularly dopaminergic and serotonergic pathways, and is primarily associated with pharmaceutical treatment of schizophrenia.

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 2.0%
Water Content NMT 1.0%
Melting Point Approximately 108°C – 112°C
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