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4.Others:
4.1.Piroxicam Standard: USP 29
Characteristics: White or slightly yellow crystalline powder
Identification: Positive Reaction
Solubility: Practically insoluble in water, soluble in methylene chloride, slightly soluble in ethanol.
Loss on drying: 0.5% Max
Residue on ignition: 0.3% Max
Heavy metals: 0.002% Max
Organic volatile impurities: 500ppm Max
Methylene chloride chloroform: 50ppm Max
Trichloroethylene: 80ppm Max
1,4-Dixoane: 100ppm Max
Benzene: 2ppm Max
Particle size: 100% < 12μm
90% < 8μm
Assay (on dry basis): 97.0 ~ 103.0%
4.2.Rebamipide Appearance: A white crystalline powder
Solubility: Soluble in DMF, slightly soluble in methanol and 95% ethanol, practically insoluble in water
Identification: IR spectrum should comply with CRS
UV Absorption maximum 228~232, 327~331
UV Absorption minimum 290 ~ 296
Chloride: 0.028% Max
Loss on drying: 3.0% Max
Residue on ignition: 0.10% Max
Heavy metals: 0.001% Max
m-Chlor isomer: 0.5% Max
Isolated Benzoyl derivates: 0.3% Max
Related substances:
Individual impurity: 0.1% Max
Total impurity: 0.5% Max
Content (on dried basis): 99.0% Min
4.3.Alibendol Assay: 99% Min
Appearance: Crystalline white powder
Heavy metals: 20 ppm Max
Ethanolamine: 0.1% Max
Residues on ignition: 0.2% Max
Absorbance: 150 - 158 at 315 nm
Impurities: 1.0% Max
Loss on drying: 1.0% Max
Melting Point: 98.0 Assay: 99.0% Min (HPLC)
4.4.Indomethacin Characteristics: White or yellow crystalline powder, practically insoluble in water, sparingly soluble in alcohol
