Sulpiride is a substituted benzamide-class active pharmaceutical ingredient (API) with selective dopamine D₂ receptor antagonist activity. It has CAS Number 15676-16-1, molecular formula C₁₅H₂₃N₃O₄S and molecular weight 341.43 g/mol.
Sulpiride is chemically identified as N-[(1-ethylpyrrolidin-2-yl)methyl]-2-methoxy-5-sulfamoylbenzamide and is generally characterized as a white to almost-white crystalline powder or crystals.
Sulpiride belongs to the substituted benzamide class of compounds. Its structure contains a methoxybenzamide group, sulfamoyl functionality and an N-ethylpyrrolidine moiety.
The API is characterized using established pharmaceutical analytical procedures including spectroscopic identification, chromatographic testing and pharmacopoeial assay procedures.
Sulpiride has a molecular weight of 341.43 g/mol and is supplied as a solid pharmaceutical material.
Sulpiride is primarily associated with pharmaceutical applications involving dopamine D₂ receptor antagonism. It has been used as an antipsychotic API and has also been used in certain countries for other approved psychiatric or gastrointestinal indications, depending on local regulatory status.
Its pharmacological activity is associated with antagonism of dopamine D₂ receptors. Sulpiride therefore belongs to the dopamine-receptor antagonist class of pharmaceutical compounds.
Sulpiride API can be evaluated using identity, assay, moisture, inorganic-residue, impurity and physical-property testing according to the applicable pharmacopoeial or customer specification.
The Japanese Pharmacopoeia specifies Sulpiride at 98.0–102.0% calculated on the dried basis. The JP monograph also specifies loss on drying of not more than 0.5% and residue on ignition of not more than 0.1%.
Typical analytical controls may include:
Commercial analytical specifications may additionally include HPLC purity; TCI reports a minimum HPLC purity of 98.0 area%.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities for Sulpiride with quality-focused analytical evaluation and documentation.
Sulpiride API can be handled according to applicable pharmacopoeial requirements and agreed customer specifications. Quality evaluation can cover identity, assay, moisture, impurities, physical characteristics and other applicable quality attributes.
For pharmaceutical companies requiring Sulpiride API from an India-based manufacturer, specification alignment, batch consistency, analytical testing and appropriate documentation are important considerations.
Sulpiride API should be stored in suitable, tightly closed pharmaceutical packaging that protects the material from contamination, moisture and excessive environmental exposure.
The Japanese Pharmacopoeia specifies well-closed containers for Sulpiride.
Recommended handling includes:
Depending on customer and regulatory requirements, documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API manufacturing with quality systems, analytical evaluation and documentation intended to support pharmaceutical applications.
Sulpiride API is handled according to defined quality requirements with attention to identity, assay, impurities, physical characteristics and batch-to-batch consistency.
Customers can discuss Sulpiride API requirements, applicable specifications, packaging and documentation with Swapnroop Drugs and Pharmaceuticals.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Melting Point | 179–185°C |