ChP, USP, EP Amphotericin B 1397-89-3

ChP, USP, EP Amphotericin B 1397-89-3

Product Name

Amphotericin B non-sterile

Other name

Fungizone; Amfostat; Ampho-Moronal; Amphotericin; Anfotericina B, Fungilin; Fongizone, Lushanmycin

Quality

USP37

Cas:

1397-89-3

EINECS

215-742-2

Molecular Formula

C47H73NO17

Molecular Weight

924.08

Functions

(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

Test

Specifications

Results

Description

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.

Conforms

Identification: UV

Conforms

Conforms

Loss on Drying

≤5.0％

0.84%

Residual on ignition

≤3.0％

0.8%

Amphotericin A

≤15.0％

1.8%

Residual Solvents

Methanol ≤0.3％

0.049%

Acetone ≤0.5％

0.16%

Assay（Calculated on the Dried Bases）

≥750μg/mg

1028μg/mg

Conclusion

Conforms to USP 37 specification (used for dermatological creams, lotions, and ointments, and oral suspensions and capsules)