we have fda/cos/gmp
prednisolone
appearance |
white or almost white,crystalline,hygroscopic powder |
identification |
ir:conforms to the crs spectrum uv:absorptivities a 242nm,calculated on the dried basis,do not differ by more than 2.5% |
specific rotation |
+97°~ +103° |
loss on drying |
≤1.0% |
residue on ignition |
negligible,from 100mg |
selenium |
0.003%.200mg test specimen being used |
chromatographic purity(hplc) |
any individual impurity≤1.0% ≥0.5% impurity not more than one total impurities≤2.0% |
assay (by hplc) |
contains 97.0%~102.0% of c21h28o5 calculated on anhydrous basis |
residual solvents |
methanol≤3000ppm ethanol≤3000ppm methylene≤600ppm |
particle size |
99%≤30µm |