Transcription of MAGNESIUM STEARATE - uspbpep.com
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MAGNESIUM STEARATE - uspbpep.com
EUROPEAN PHARMACOPOEIA stearateColumn: size:l= , = , stationary phase:octadecylsilyl silica gel forchromatography R(5 m).Mobile phase: dissolve g ofsodium dihydrogenphosphate Rin 1000 ml ofwater Rand adjust to pH witha10percentV/Vsolution ofphosphoric acid : spectrophotometer at 210 : 10 l loop injector; inject the test solution andreference solutions (b), (c), (d) and (e).Run time: 4 times the retention time of pidolic times: pidolic acid = about min;impurity B = about suitability: reference solution (e): resolution: minimum 10 between the peaks due to pidolicacid and to impurity : impurity B: not more than the area of the principal peakin the chromatogram obtained with reference solution (b)( per cent), total of other impurities: not more than half of the areaof the principal peak in the chromatogram obtained withreference solution (b) ( per cent), disregard limit: not more than times the area ofthe principal peak in the chromatogram obtained withreference solution (c) ( per cent); disregard any peakcorresponding to the nitrate ion (NO3 ).
Magnesium stearate EUROPEAN PHARMACOPOEIA 6.0 Second identification: A, B, D. A. The residue obtained in the preparation of solution S (see Tests) has a freezing point (2.2.18)notlowerthan53°C.B.Theacidvalueofthefattyacids(2.5.1)is195to210,determined on 0.200 g of the residue obtained in the
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