Mesoridazine API Manufacturer in India

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

Mesoridazine API

Mesoridazine is a phenothiazine antipsychotic belonging to the thioridazine-related class of antipsychotic agents. It acts primarily through dopamine receptor antagonism and has additional effects on other neurotransmitter receptors.

Mesoridazine was historically used in the management of schizophrenia and other psychotic disorders. Its clinical use has been discontinued or restricted in many markets because of significant cardiac safety concerns, particularly QT-interval prolongation and risk of serious ventricular arrhythmias.

Mesoridazine API Manufacturer in India

Mesoridazine is a specialized CNS / antipsychotic pharmaceutical API relevant to pharmaceutical research and reference-standard applications. Due to its historical regulatory status and safety profile, its commercial use should be evaluated against current applicable regulations.

Chemical Information

CAS Number: 5588-33-0
Molecular Formula: C21H26N2O2S2
Molecular Weight: 386.57 g/mol
Chemical Name: Mesoridazine
Drug Class: Phenothiazine Antipsychotic
Therapeutic Class: Antipsychotic
Therapeutic Area: Psychiatry / CNS
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Mesoridazine produces antipsychotic effects primarily through dopamine receptor antagonism, particularly at central dopamine receptors.

Its pharmacological activity also involves interactions with other neurotransmitter systems, contributing to its broader CNS effects.

Key pharmacological actions include:

  • Dopamine receptor antagonism
  • Modulation of central neurotransmission
  • Antipsychotic activity
  • Additional anticholinergic and adrenergic effects

Pharmaceutical Applications

Historically, Mesoridazine was associated with:

  • Schizophrenia
  • Psychotic disorders
  • Antipsychotic pharmaceutical research
  • Phenothiazine pharmacology
  • CNS drug research

Regulatory and Safety Consideration

Mesoridazine is notable for its cardiac electrophysiological safety concerns. It can prolong the QT interval and has been associated with potentially serious ventricular arrhythmias, including torsades de pointes.

Because of these concerns, mesoridazine's marketed clinical use has been withdrawn or discontinued in several jurisdictions. Therefore, any API listing should clearly distinguish it from currently marketed antipsychotic APIs and should comply with applicable regulatory requirements.

Dosage Form Applications

Historically, Mesoridazine was available in oral pharmaceutical formulations, including tablets and oral liquid preparations.

Physical Characteristics

Mesoridazine is generally handled as a solid pharmaceutical substance. Appearance, crystalline characteristics and other physical properties should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Mesoridazine API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of phenothiazine intermediates
  3. Controlled side-chain synthesis
  4. Chemical coupling and functional-group modification
  5. Purification
  6. Crystallization or isolation
  7. Filtration
  8. Controlled drying
  9. Milling or sieving where required
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Mesoridazine API testing may include:

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

Storage

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

Pharmaceutical Research

Mesoridazine is relevant to research involving:

  • Phenothiazine antipsychotics
  • Dopamine receptors
  • CNS pharmacology
  • Schizophrenia research
  • Antipsychotic drug development
  • QT-interval prolongation
  • Cardiac safety pharmacology
  • Historical antipsychotic compounds

Mesoridazine API Summary

Mesoridazine is a phenothiazine antipsychotic compound with CAS Number 5588-33-0, molecular formula C21H26N2O2S2, and molecular weight 386.57 g/mol. It was historically used as an antipsychotic but is particularly notable for cardiac safety concerns involving QT prolongation and ventricular arrhythmias.

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 20 ppm
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
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