Transcription of Amikacini sulfas - uspbpep.com
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Amikacini sulfas - uspbpep.com
EUROPEAN PHARMACOPOEIA sulphateReference solution (c).Dissolve 5 mg ofamikacin CRSand5mgofamikacin impurity A CRSinwater Rand dilute to50 ml with the same solvent. Then prepare as prescribed fortest solution (a).Blank as described for test solution (a)using ml ofwater : size:l= , = ; stationary phase:octadecylsilyl silica gel forchromatography R(5 m); temperature:30 phase: mix 30 volumes of a g/l solution ofpotassium dihydrogen phosphate R, 22 g/l solution ofpotassium hydroxide R,and70volumesofmethanol rate:1 : spectrophotometer at 340 : 20 l of test solution (a) and reference solutions (a)and (c).Run time: 4 times the retention time of suitability: reference solution (c): resolution: minimum between the peaks due toamikacin and impurity A (see Figure ).Limits: impurity A: not more than the area of the principal peakin the chromatogram obtained with reference solution (a)(1 per cent); any other impurity:foreachimpurity,notmorethan times the area of the principal peak in thechromatogram obtained with reference solution (a)( per cent); sum of impurities other than area of the principal peak in the chromatogramobtained with reference solution (a) ( per cent); disregard limit: times the area of the principal peakin the chromatogram obtained with reference solution (a)( per cent); disregard any peak due to the ( ): maximum per cent, determined ash( )): maximum per cent, determinedon chromatography ( ) as describ
Amikacin sulphate EUROPEAN PHARMACOPOEIA 6.0 Test solution.Dissolve 25 mg of the substance to be examined in water Rand dilute to 10 ml with the same solvent. Reference solution (a).Dissolve 25 mg ofamikacin sulphate CRS in water R and dilute to 10 ml with the same solvent.
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