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Items
Specifications
Results
Characters
A white crystalline powder
A white crystalline powder
Identification
Complies
Complies
Acidity or alkalinity
PH 5.5−7.5
6.1
Specific optical rotation
+215°-+230°
+229°
Related substances
Apart from the principal peak and any peak corresponding to 4-hydroxyphenoxymethyl-penicillin,is not greater than the area of the principal peak in the chromatogram obtained with reference solution(1 per cent)
Complies
4-Hydroxyphenoxymethylpenicillin potassium
not more than 4.0%
1.1%
Water
not more than 1.0%
0.1%
Assay
The sum of the percentage contents of phenoxymethylpenicillin potassium and 4 -Hydroxyphenoxymethylpenicillin potassium is not less than 95.0 per cent and not more than the equivalent of 100.5 per cent,calculated with reference to the anhydrous substance
100.0%
Potency(on dried basis)
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1512u/mg
Function and Use: To the treatment of penicillin G-sensitive mild, moderate, severe infection, and surgery for the prevention of rheumatic fever, cholera and to prevent the recurrence of bacterial endocarditis.Ear, nose and throat infections caused by sensitive bacteria, such as flat pick pancreatitis, pharyngitis, otitis media. Respiratory tract infections: pneumonia. Skin infections; such as erysipelas, erysipelas and transitional types of erythema; scarlet fever; the prevention of the recurrence of acute rheumatic fever; the prevention of teeth, mouth, jaw and upper respiratory tract of endocarditis after surgery.
China
