Amphotericin B Specification
Amphotericin B Pharma Grade ECOA
|
ITEM |
STANDARD |
RESULTS |
|
Appearance |
Yellow to orange powder, odorless or practically so |
Yellow powder |
|
Solubility |
Insoluble in water and in ether,slightly soluble in methanol |
Complies |
|
Identification A: (UV) |
Conforms to standard; absorbance in the range of 240nm to 320nm |
Complies |
|
Identification B: (UV/Vis ) |
Conforms to standard; absorbance in the range of 320nm to 400nm |
Complies |
|
Loss on drying |
Not more than 5.0% |
1.5% |
|
Residue on Ignition |
Not more than 3.0% |
0.4% |
|
Limit amphotericin A |
Not more than 15.0% |
Not detected |
|
Assay (microbial) |
Not less than 750 ug/mg calculated on the dried basis |
894 ug/mg |
|
Residual Solvents Ethanol Acetone |
Not more than 5000 ppm Not more than 5000 ppm |
3309ppm 1346ppm |
|
Conclusion |
Complies with USP34 |
|
Medical uses
Antifungal
One of the main uses of amphotericin B is treating a wide range of systemic fungal infections.
Due to its extensive side effects, it is often reserved for severe infections in critically ill, or
immunocompromised patients. It is considered first line therapy for invasive mucormycosis
infections, cryptococcal meningitis, and certain aspergillus and candidal infections.
Antiprotozoal
Amphotericin B is often used in otherwise-untreatable protozoan infections such as visceral leishmaniasis and primary amoebic
meningoencephalitis.
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