happymingxu
第10楼2007/06/06
Prednisolone
C21H28O5(anhydrous) 360.45
Pregna-1,4-diene-3,20-dione,11,17,21-trihydroxy-,(11)-.
11,17,21-Trihydroxypregna-1,4-diene-3,20-dione (anhydrous) [50-24-8].
Sesquihydrate 387.48 [52438-85-4].
»Prednisolone is anhydrous or contains one and one-half molecules of water of hydration.It contains not less than 97.0percent and not more than 102.0percent of C21H28O5,calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label it to indicate whether it is anhydrous or hydrous.
USP Reference standards á11ñ— USP Prednisolone RS.
Identification—
A:Infrared Absorption 197K.
B:Ultraviolet Absorption á197Uñ—
Solution: 10µg per mL.
Medium: methanol.
Absorptivities at 242nm,calculated on the dried basis, do not differ by more than 2.5%. If a difference appears, dissolve portions of both the test specimen and the Reference Standard in ethyl acetate, evaporate the solutions to dryness, and repeat the test on the residues.
Specific rotation 781S: between +97 and +103 .
Test solution: 10mg per mL,in dioxane.
usp里面Prednisolone 的质量标准!