Gepirone API | Gepirone Hydrochloride Pharmaceutical API Manufacturer in India

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Gepirone API

Gepirone is a synthetic azapirone-class serotonin 5-HT1A receptor agonist developed primarily for the treatment of major depressive disorder (MDD). It acts preferentially on 5-HT1A receptors and is structurally related to other azapirone compounds.

Gepirone is commonly formulated as gepirone hydrochloride, the hydrochloride salt used in pharmaceutical development and drug formulations.

Gepirone API Manufacturer in India

Gepirone Hydrochloride is a specialized CNS pharmaceutical active ingredient. It belongs to the serotonin receptor-modulating class and has been developed as an oral antidepressant for adults with major depressive disorder.

Chemical Information

CAS Number: 83928-76-1
Molecular Formula: C19H29N5O2
Molecular Weight: 359.47 g/mol
Common Form: Gepirone Hydrochloride
Drug Class: Azapirone
Pharmacological Class: 5-HT1A Receptor Agonist
Therapeutic Class: Antidepressant
Therapeutic Area: Psychiatry / CNS

Mechanism of Action

Gepirone acts as an agonist at serotonin 5-HT1A receptors. Activation of these receptors influences serotonergic neurotransmission within the central nervous system and is considered the primary pharmacological mechanism underlying its antidepressant activity.

Pharmaceutical Applications

Gepirone Hydrochloride has been developed for the treatment of major depressive disorder in adults. An extended-release formulation was developed to provide once-daily oral administration.

Gepirone Hydrochloride

Gepirone hydrochloride is the hydrochloride salt form of gepirone. Salt formation is used to provide suitable physicochemical and pharmaceutical properties for formulation and drug-product manufacturing.

Physical and Chemical Properties

Gepirone is a synthetic azapirone compound containing a piperazine-derived structure and an oxopyrimidinone moiety. The free-base molecular formula is C19H29N5O2, with a molecular weight of 359.47 g/mol. The hydrochloride salt has a higher molecular weight due to the addition of hydrochloride.

Quality and Analytical Testing

Gepirone Hydrochloride API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • LC-MS confirmation
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Particle-size testing where applicable
  • Solid-state characterization where applicable

Storage

Gepirone Hydrochloride should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Final storage requirements should follow validated stability data and the applicable material-specific specification.

Pharmaceutical Research and Development

Gepirone has been investigated as a selective serotonergic antidepressant. Its development has focused on 5-HT1A receptor agonism and its potential role in improving depressive symptoms while providing an alternative pharmacological approach to conventional antidepressant therapies.

Gepirone API Summary

Gepirone is a synthetic 5-HT1A receptor agonist of the azapirone class developed for major depressive disorder. It is commonly associated with its hydrochloride salt form and is administered orally in extended-release pharmaceutical formulations.

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
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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