Fluconazole Chemical

Sr No. Test Specification Result 1 APPEARANCE A White to off white crystalline powder A whit Crystalline Powder 2 SOLUBILITY Freely soluble in Methanol, Chloroform & slightly soluble in Water Complies 3 IDENTIFICATION BY TLC Compared with standard Complies 4 MELTNG POINT 1360C to 1400 C 1370C to 1380C 5 LOSS ON DRYING Not more than 0.5% w/w 0.11% 6 HEAVY METAL Not more than 20ppm 8ppm 7 IRON AS Fe Not more than 20ppm 9ppm 8 SULPHATED ASH Not more than 0.20%w/w 0.08% 9 RELATED SUBSTANCE (BY HPLC) Individual impurity is NMT0.3% Total of the impurity NMT 0.5% Individual impurity 0.20% Total impurity 0.20% 10 ASSY (on dry basis) (By chemically) Not less than 98.50% Not less than 101% 99.25 %