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POLYSORBATE 20 - uspbpep.com
EUROPEAN PHARMACOPOEIA 20 Calculate 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, :0426 POLYSORBATE 20 Polysorbatum 20 DEFINITIONM ixture 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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