Rebamipide is a pharmaceutical active ingredient belonging to the quinolinone derivative class and is widely recognized for its gastroprotective properties. It is used in pharmaceutical formulations intended to support gastric mucosal protection and the management of gastric mucosal disorders. Rebamipide is identified by CAS No. 90098-04-7 and has the molecular formula C19H15ClN2O4 with a molecular weight of 370.79 g/mol.
Rebamipide API is characterized by established pharmacopoeial quality requirements, particularly under the Japanese Pharmacopoeia (JP). Its quality evaluation includes assay, loss on drying, residue on ignition, heavy metals, chloride and related-substance testing. The JP specifies 99.0–101.0% Rebamipide on the dried basis.
Rebamipide is chemically described as (2RS)-2-(4-Chlorobenzoylamino)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic acid. It occurs as a white crystalline powder and is practically insoluble in water, very slightly soluble in methanol and ethanol, and soluble in N,N-dimethylformamide. The substance is racemic and does not exhibit optical rotation in the pharmacopoeial test solution.
The API has a reported melting point of approximately 291°C with decomposition.
Rebamipide contains a quinolinone ring system together with a 4-chlorobenzoylamino propionic acid structure. Its defined pharmaceutical identity is supported by UV, infrared and pharmacopoeial identification testing.
| Parameter | Value |
|---|---|
| Chemical Name | (2RS)-2-(4-Chlorobenzoylamino)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic acid |
| CAS Number | 90098-04-7 |
| Molecular Formula | C19H15ClN2O4 |
| Molecular Weight | 370.79 g/mol |
| Chemical Class | Quinolinone derivative |
| Physical Form | White crystalline powder |
| Pharmacopoeial Standard | Japanese Pharmacopoeia |
| Melting Point | About 291°C, with decomposition |
| Optical Rotation | No optical rotation |
| Water Solubility | Practically insoluble |
Rebamipide is primarily used as a gastroprotective pharmaceutical ingredient. It is associated with gastric mucosal protection and is used in pharmaceutical products for gastric ulcer and gastric mucosal disorders. PubChem describes Rebamipide as a quinolinone derivative with anti-ulcer and anti-inflammatory activity.
Its pharmaceutical applications include formulations designed for:
Rebamipide API can be evaluated according to Japanese Pharmacopoeia requirements. The official monograph specifies identification by UV, IR and flame coloration testing and establishes numerical limits for assay and several purity attributes.
Important quality-control parameters include:
Rebamipide API manufacturing and quality control require consistent control of chemical identity, assay, physical characteristics and related substances. Pharmacopoeial testing provides a defined framework for evaluating Rebamipide quality, with the Japanese Pharmacopoeia specifying an assay range of 99.0–101.0% on the dried basis.
Quality-focused manufacturing programs can incorporate validated analytical procedures for chromatographic purity, identification, residual inorganic impurities and physical characteristics to support pharmaceutical applications.
Rebamipide should be handled in suitable pharmaceutical-grade packaging that protects the API from environmental contamination and light. The Japanese Pharmacopoeia specifies well-closed containers and light-resistant storage.
Typical Rebamipide API documentation may include:
Rebamipide is supported by established pharmacopoeial quality requirements, making analytical consistency and specification control important for pharmaceutical manufacturing. A properly controlled Rebamipide API program should address assay, related substances, drying loss, inorganic impurities, physical characteristics and appropriate documentation.
The Japanese Pharmacopoeia provides specific numerical requirements for several critical quality attributes, including assay, chloride, heavy metals, loss on drying and residue on ignition.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–101.0% on dried basis |
| Loss on Drying | NMT 3.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 1.0% |