Superiority
No. TEST SPECIFICATIONS RESULTS
1. Description Yellow Crystalline Powder. Complies
2. Solubility Soluble in Chloroform & slightly in Acetone. Comp…
Details
No. TEST SPECIFICATIONS RESULTS
1. Description Yellow Crystalline Powder. Complies
2. Solubility Soluble in Chloroform & slightly in Acetone. Complies
3. Loss on drying at 1050C NMT 0.2 % w/w 0.086%
4. Identification by TLC Any spot in the chromatogram other than the principle spot obtained with solution (1) in not more intense than the principle spot obtained with solution (2) and not more than four spots are observed. Complies
6. Melting Point Between 1250C and 1310C 1280C to 1310C
7. Heavy metals NMT 0.002 % 0.001 %
8. Assay 98.0 % to 101.0 % 99.84 %
9. Related Substance
( By HPLC ) 1. 2-(Di-butylamino)-1-[2,7-dichloro-9H fluoren- 4-yl]-ethanol : NMT 0.2 %
2. Any other impurity : NMT 0.1 %
3. Total impurity : NMT 0.5 % 0.10 %
0.05 %
0.19 %