POLYSORBATE 20 - uspbpep.com
EUROPEAN PHARMACOPOEIA 20Calculate the percentage content of polymyxin B3, ofpolymyxin B1-I, and of the sum of polymyxins B1, B2, B3and B1-I, using the following expression:CBi=percentage content of polymyxin Bi;ABi=area of the peak due to polymyxin Biin thechromatogram obtained with the test solution;m1=mass of the substance to be examined (driedsubstance) in the test solution, in milligrams;BBi=area of the peak due to polymyxin Biinthe chromatogram obtained with referencesolution (a);m2=mass ofpolymyxin B sulphate CRSin referencesolution (a), in milligrams;DBi=declared percentage content for polymyxin Biinpolymyxin B sulphate an airtight container, protected from light. If thesubstance is sterile, store in a sterile, airtight, :0426POLYSORBATE 20Polysorbatum 20DEFINITIONMixture of partial esters of fatty acids, mainly lauric(dodecanoic) acid, with sorbitol and its anhydridesethoxylated with approximately 20 moles of ethylene oxidefor each mole of sorbitol and sorbitol : oily, yellow to brownish-yellow, clear or slightlyopalescent : soluble in water, in ethanol, in ethyl acetate andin methanol, practically insoluble in fatty oils and in : about 400 mPa s at 25 identication: A, :B,C,D, Infrared absorption spectrophotometry ( ).
EUROPEAN PHARMACOPOEIA 6.0 Polysorbate 20 Calculate the percentage content of polymyxin B3, of polymyxin B1-I, and of the sum of polymyxins B1, B2, B3 and B1-I, using the following expression:
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