Granisetron Hydrochloride, commonly known as Granisetron HCl, is the hydrochloride salt of granisetron and belongs to the class of selective 5-HT3 receptor antagonists. It is primarily used as an antiemetic for the prevention and treatment of nausea and vomiting associated with chemotherapy, radiotherapy and other medical procedures.
Granisetron Hydrochloride has the molecular formula C18H25ClN4O and a molecular weight of approximately 348.9 g/mol. The CAS Number is 107007-99-8.
Granisetron Hydrochloride is described in the Indian Pharmacopoeia Commission monograph as a white or almost white powder. A 1.0% w/v aqueous solution is specified to be clear and colourless, with a pH of 4.0 to 6.5.
The Indian Pharmacopoeia Commission specifies that Granisetron Hydrochloride contains 97.0% to 102.0% of C18H25ClN4O, calculated on the dried basis. The monograph also specifies limits for related substances, sulphated ash and loss on drying.
Granisetron Hydrochloride is a selective serotonin 5-HT3 receptor antagonist. By blocking serotonin-mediated signaling at 5-HT3 receptors, it helps prevent nausea and vomiting. It is particularly associated with the management of nausea and vomiting caused by cancer chemotherapy and radiotherapy.
Granisetron Hydrochloride API manufacturing involves controlled synthesis, purification, drying and analytical testing. Quality control includes identity testing, assay, related substances, pH, sulphated ash and loss on drying according to the applicable pharmacopoeial or approved manufacturer specification.
For pharmaceutical applications, appropriate analytical testing is performed to confirm the chemical identity, purity and consistency of each batch.
Granisetron Hydrochloride should be stored protected from light and moisture, in accordance with the applicable pharmaceutical material specification.
Granisetron Hydrochloride is an established pharmaceutical API used as a selective 5-HT3 receptor antagonist. Its defined chemical identity, pharmacopoeial specifications and established pharmaceutical application make it an important API for antiemetic drug development and manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms by IR, HPLC and chloride reaction |
| Assay (HPLC) | 97.0% – 102.0% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 6.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |