Sinoway Industrial Co.Ltd.
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ChP, USP, EP Amphotericin B 1397-89-3
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1. Basic information for amphotericin B
Product Name
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Amphotericin B non-sterile
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Other name
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Fungizone; Amfostat; Ampho-Moronal; Amphotericin; Anfotericina B, Fungilin; Fongizone, Lushanmycin
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Quality
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USP37
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Cas:
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1397-89-3
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EINECS
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215-742-2
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Molecular Formula
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C47H73NO17
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Molecular Weight
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924.08
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2. Function for amphotericin B
Functions
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(1) Amphotericin B is an antifungal drug often used intravenously for systemic fungal infections. It is the only effective treatment for some fungal infections
(2) Common side effects may include: a reaction which may include fever, headaches and low blood pressure among other symptoms rapidly after it is given, and kidney problems. Allergic symptoms including anaphylaxis may occur
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3.Specification for Amphotericin B
Test
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Specifications
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Results
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Description
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Yellow to orange powder; odorless or practically so. Insoluble in water, in anhydrous alcohol, in ether, in benzene, and in toluene; soluble in dimethylformamide, in dimethyl sulfoxide, and in propylene glycol; slightly soluble in methanol.
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Conforms
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Identification: UV
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Conforms
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Conforms
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Loss on Drying
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≤5.0%
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0.84%
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Residual on ignition
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≤3.0%
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0.8%
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Amphotericin A
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≤15.0%
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1.8%
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Residual Solvents
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Methanol ≤0.3%
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0.049%
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Acetone ≤0.5%
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0.16%
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Assay(Calculated on the Dried Bases)
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≥750μg/mg
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1028μg/mg
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Conclusion
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Conforms to USP 37 specification (used for dermatological creams, lotions, and ointments, and oral suspensions and capsules)
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