Cinitapride is a gastroprokinetic pharmaceutical active ingredient belonging to the benzamide class. It exhibits activity at serotonin receptors, acting as an agonist at 5-HT1 and 5-HT4 receptors and as an antagonist at 5-HT2 receptors. Cinitapride is associated with the treatment of gastrointestinal motility disorders and has been used in pharmaceutical formulations for conditions such as functional dyspepsia and gastroesophageal reflux disease.
| Parameter | Details |
|---|---|
| Product Name | Cinitapride |
| Generic Name | Cinitapride |
| CAS Number | 66564-14-5 |
| Molecular Formula | C₂₁H₃₀N₄O₄ |
| Molecular Weight | 402.49 g/mol |
| Physical Form | Solid |
| Appearance | Light yellow to yellow solid |
| Chemical Class | Benzamide derivative |
| Therapeutic Class | Gastroprokinetic agent |
| ATC Classification | A03FA08 |
| Stereochemistry | Racemic |
The FDA GSRS record confirms the formula, molecular weight and racemic character, while PubChem and LGC Standards confirm CAS 66564-14-5 and the molecular data.
Cinitapride is used as a gastroprokinetic agent and has been investigated/used in relation to functional dyspepsia and gastroesophageal reflux disease (GERD).
Cinitapride API is evaluated using appropriate analytical controls for identity, assay, related substances, water content and other applicable pharmaceutical quality parameters.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to Cinitapride identification by IR/HPLC |
| Assay (HPLC) | ≥98.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Solubility | Sparingly soluble in water; soluble in organic solvents |