Granisetron Hydrochloride API | Pharmaceutical API Manufacturer in India

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Granisetron Hydrochloride API

Granisetron Hydrochloride is the hydrochloride salt of granisetron, a selective 5-HT3 receptor antagonist used primarily for the prevention and treatment of nausea and vomiting associated with cancer chemotherapy, radiation therapy and certain surgical procedures.

Granisetron works by blocking serotonin (5-hydroxytryptamine, 5-HT) from activating 5-HT3 receptors involved in the vomiting reflex.

Granisetron Hydrochloride API Manufacturer in India

Granisetron Hydrochloride is a pharmaceutical API used in the development and manufacture of antiemetic formulations. Its production involves controlled chemical synthesis, purification and analytical testing to maintain consistent assay, stereochemical purity and impurity profile.

Chemical Information

CAS Number: 107007-99-8
Molecular Formula: C18H25Cl2N3O
Molecular Weight: 348.22 g/mol
Chemical Name: Granisetron Hydrochloride
Drug Class: 5-HT3 Receptor Antagonist
Therapeutic Class: Antiemetic
Therapeutic Area: Oncology / Gastroenterology / Perioperative Medicine

Mechanism of Action

Granisetron Hydrochloride selectively antagonizes 5-HT3 receptors located on vagal nerve terminals and in the central nervous system.

During chemotherapy and other emetogenic conditions, serotonin release can stimulate these receptors and initiate signals contributing to nausea and vomiting. Granisetron blocks this receptor-mediated signaling and helps prevent the vomiting response.

Pharmaceutical Applications

Granisetron Hydrochloride is used for the prevention and treatment of nausea and vomiting associated with:

  • Cancer chemotherapy
  • Radiation therapy
  • Surgical procedures

The specific approved indication depends on the formulation and applicable regulatory labeling.

Granisetron Hydrochloride in Antiemetic Therapy

Granisetron is particularly useful in oncology supportive care because serotonin-mediated signaling through 5-HT3 receptors is an important component of chemotherapy-induced nausea and vomiting (CINV).

Physical and Chemical Properties

Granisetron Hydrochloride is a synthetic small-molecule pharmaceutical ingredient supplied as a hydrochloride salt. It is generally described as a white to off-white crystalline solid and is soluble in water.

Quality and Analytical Testing

Granisetron Hydrochloride API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Enantiomeric purity
  • Water content
  • Residual solvents
  • Residue on ignition
  • Heavy metals / elemental impurities
  • Particle-size analysis where applicable

Storage

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

Pharmaceutical Research and Development

Granisetron Hydrochloride remains an established pharmaceutical ingredient in antiemetic drug development, particularly for formulations intended to prevent nausea and vomiting associated with cancer treatment and surgical procedures.

Granisetron Hydrochloride API Summary

Granisetron Hydrochloride is a 5-HT3 receptor antagonist API with CAS Number 107007-99-8, molecular formula C18H25Cl2N3O, and molecular weight 348.22 g/mol. It is primarily used in antiemetic therapy for the prevention and treatment of nausea and vomiting associated with chemotherapy, radiation and surgery.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification Conforms by IR and HPLC
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) 4.0 – 6.0
Water Content NMT 2.0%
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