AmphotericinB,EPmeetsEuropeanPharmacopoeiaspecifications.
CASNumber
1397-89-3
MolecularFormula
C47H73NO17
MolecularWeight
924.08
MechanismofAction
AmphotericinBassociateswithmembranesterolsinmammalianandfungalcellmembranes.AmphotericinBformsaporeinthesemembranesleADIngtoessentialionleakageandultimately,celldeath.
StorageConditions
2-8°C
TariffCode
2941.90.1050
Spectrum
AmphotericinBisactiveagainstmammalianandfungal(moldsandyeasts)cells.AmphotericinBisnottoxictobacteriaduetotheirlackofsterols.ThefollowingrepresentsMICsusceptibilitydataforamphotericinBagainstcommonfungalpathogens:
- Candidaalbicans -0.001-321μg/mL
- Candidakrusei -0.001-16μg/mL
- Coccidioidesimmitis -0.0625-2μg/mL
- Cryptococcusneoformans -0.2-39μg/mL
- Fusariumoxysporum -0.75-125μg/mL
Form
Powder
Appearance
YelloworOrangehygroscopicpowder
Source
Streptomycesnodosus
Absorbance
UVmax:362,381and405nm
UVratios:
A362/A381=0.57-0.61
A381/A405=0.87-0.93
Assay
(OnDriedBasis):≥750IU/mg
LossonDrying
≤5.0%
SulfatedAsh
≤3.0%
Impurities
RelatedSubstances
ImpurityA(303nm):≤5.0%
AnyOtherImpurity(303nm):≤1.0%
ImpurityB(383nm):≤4.0%
AnyOtherImpurity(383nm):≤2.0%
TotalImpurities(303nmand383nm):≤15.0%