Transcription of LACTOSE MONOHYDRATE - uspbpep.com
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LACTOSE MONOHYDRATE - uspbpep.com
EUROPEAN PHARMACOPOEIA monohydrateBulkandtappeddensity( ). Determine the bulkdensity and the tapped density. Calculate the Hausner indexusing the following expression:V0=volume of bulk substance,Vf=volume of tapped substance. - LACTOSE and ( ).Silylation Rand 72 volumes ofpyridine solution. Dissolve about 1 mg of the substance to beexamined in ml ofdimethyl sulphoxide the silylation reagent. Mix gently and allow to stand for20 solution. Prepare a mixture of -lactosemonohydrate Rand - LACTOSE Rhaving an anomeric ratio ofabout 1:1 based on the labelled anomeric contents of the - LACTOSE MONOHYDRATE and - LACTOSE . Dissolve about 1 mgof this mixture in ml ofdimethyl sulphoxide ml of the silylation reagent. Mix gently and allow tostand for 20 : material: glass, size:l= , =4mm, stationary phase:silanised diatomaceous earth for gaschromatography Rimpregnated with 3 per centm/mofpoly[(cyanopropyl)(methyl)][(ph enyl)(methyl)]siloxane gas:helium for chromatography rate:40 : column:215 C, injection port and detector:275 :2 suitability: reference solution: relative retentionwith reference to - LACTOSE : - LACTOSE = about , resolution: minimum between the peaks due to - LACTOSE and the percentage content of - LACTOSE from theexpression:Calculate the percentage content of - LACTOSE from theexpression:Sa=area of the peak due to - LACTOSE ,Sb=area of the peak due to on drying( ).
EUROPEAN PHARMACOPOEIA 5.0 Lactose monohydrate Bulkandtappeddensity(2.9.15).Determine the bulk density and the tapped density. Calculate the Hausner index using the following expression:
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