Business Type:Lab/Research institutions
Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Lab/Research institutions
CAS NO.862-89-5
A(1-10)GramA(20-50)Gram
Product Name: Amphotericin B
Synonyms: Amfostat,Ampho-Moronal,Amphotericin,Anfotericina B,Fongizone,Fungilin,Fungizone,Lushanmycin,Wypicil
CAS: 1397-89-3
Molecular Formula: C47H73NO17
Standard: USP32
Amphotericin B (Fungilin, Fungizone, Abelcet, AmBisome, Fungisome, Amphocil, Amphotec) is a polyene antifungal drug, often used intravenously for systemic fungal infections. It was originally extracted from Streptomyces nodosus, a filamentous bacterium, in 1955 at the Squibb Institute for Medical Research from cultures of an undescribed streptomycete isolated from the soil collected in the Orinoco River region of Venezuela. Its name originates from the chemical's amphoteric properties. Two amphotericins, amphotericin A and amphotericin B are known, but only B is used clinically, because it is significantly more active in vivo. Amphotericin A is almost identical to amphotericin B (having a double C=C bond between the 27th and 28th carbon), but has little antifungal activity. Currently, the drug is available as plain amphotericin B, as a cholesteryl sulfate complex (ABCD), as a lipid complex (ABLC), and as a liposomal formulation (LAmB). The latter formulations have been developed to improve tolerability for the patient, but may show considerably different pharmacokinetic characteristics compared to plain amphotericin B.
ITEMS
|
LIMIT |
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 |
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
|
Not less than 750 ug/mg calculated on the dried basis |
Total Aerobic count
|
Not more than 100CFU/gram |
Salmonella species
|
Negative |
Eschenchia Coli
|
Negative |
Ethanol
|
Not more than 5000ppm |
Acetone
|
Not more than 5000ppm |