Items
USP injection Standards
Appearance
White to orange powder. No visible evidence of contamination by foreign matter
Identification
UV
UV/Vis
IR
Color
Loss on drying
5.0% max
Absorbance ration
362/381=0.57 to 0.61
381/405=0.87 to 0.93
Residue on ignition
0.5% max
Solubility
Passed test
Amphotericin A
5% max (on dried basis)
Related substances
Amphotericin B methylester: 2.0% max
Any individual unknown: 2.0% max
Total unknown impurities: 7.0% max
Total impurities : 9.0% max
Assay (microbial )
840ug/mg min (on dried basis)
Assay (HPLC)
90% min (on an anhydrous weight basis)
Microbial limits
Total aerobic count: 100cfu/gram max
Salmonella species: Negative
Eschenchia coli: Negative
Bacterial endotoxins
1EU/mg max
Residual solvents
Ethanol: 5000ppm max
DMF: 6000ppm max
Acetone: 5000ppm max