Tests |
Specifications |
|
Appearance |
Yellow to orange powder, odorless or practically so. |
|
Solubility |
Insoluble in water and in ether,slightly soluble in methanol |
|
Identification A: (UV) |
Conforms to standard; absorbance in the range of 240nm to 320nm |
|
Identification B: (UV/Vis ) |
Conforms to standard; absorbance in the range of 320nm to 400nm |
|
Loss on drying |
Not more than 5.0% |
|
Residue on Ignition |
Not more than 3.0% |
|
Limit amphotericin A |
Not more than 15.0% |
|
Assay (microbial) |
Not less than 750 μg/mg calculated on the dried basis |
|
Residual Solvents |
Ethanol |
Not more than 5000 ppm |
|
Acetone |
Not more than 5000 ppm |
Total aerobic acount |
Not more than 100CFU/G |
|
Salmonella Specifies |
Negative |
|
Escherichia Coli |
Negative |
Grupos de Producto : API