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Specification of Ornidazole

Tests	Specification
Description	White to slightly yellowish Powder
Solubility	Soluble in Chloroform
Identification	By IR
Melting Point	85^oC to 90^oC
Heavy Metals	Not more than 10PPM
Loss on drying	Not more than 0.5%
Sulphate Ash	Not more than 0.2%
Clarity & Color of Solution	A5% w/v solution in acetone is clear and free from visible foreign particles and absorbance at 450nm is not more than 0.020
Related substance By HPLC	[1] Individual known impurity : (i) 2-methyl-5-nitro imidazole : Not more than 0.2 % (ii)Ornidazole Isomer : Not more than 0.5 % [2] Individual unknown impurities : Not more than 0.2 % [3] Total Impurities : Not more than 1.0 %
Assay	Not less than 98.0 % and not more than 102.0 % w/w of C₇H₁₀CIN₃O₃ calculated on dried basis

Ornidazole | Fluconazole | Tizanidine HCL | Fluxetine HCL