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    The dissolution specifications for kanamycin sulfate capsules require determining the amount dissolved using the assay procedure and making any necessary modifications, with not less than 72% of the labeled amount dissolving within 12 minutes in medium (pH 7.1-7.3) using Apparatus 1 at 100 rpm. We would suggest an enteric-coated tablet dissolution test by placing the tablet in acidic environment (pH 1.2-4.5) for a couple hours and then raising the pH to 6.2-7.2 to simulate the intestine. Our tablets had the lowest RSD in weight variation because the tablet making machine provides a precise process that avoids manhandling errors seen with other dosage forms.

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    lab_3 247

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    The dissolution specifications for kanamycin sulfate capsules require determining the amount dissolved using the assay procedure and making any necessary modifications, with not less than 72% of the labeled amount dissolving within 12 minutes in medium (pH 7.1-7.3) using Apparatus 1 at 100 rpm. We would suggest an enteric-coated tablet dissolution test by placing the tablet in acidic environment (pH 1.2-4.5) for a couple hours and then raising the pH to 6.2-7.2 to simulate the intestine. Our tablets had the lowest RSD in weight variation because the tablet making machine provides a precise process that avoids manhandling errors seen with other dosage forms.

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    Questions To Be Answered

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    priyapatel497
    The dissolution specifications for kanamycin sulfate capsules require determining the amount dissolved using the assay procedure and making any necessary modifications, with not less than 72% of the labeled amount dissolving within 12 minutes in medium (pH 7.1-7.3) using Apparatus 1 at 100 rpm. We would suggest an enteric-coated tablet dissolution test by placing the tablet in acidic environment (pH 1.2-4.5) for a couple hours and then raising the pH to 6.2-7.2 to simulate the intestine. Our tablets had the lowest RSD in weight variation because the tablet making machine provides a precise process that avoids manhandling errors seen with other dosage forms.

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    QUESTIONS TO BE ANSWERED 1) What are the dissolution specifications of another USP monographed tablet or capsule?

    Summarize the dissolution specifications for a USP monographed tablet or capsule that begins with the same letter as your last name. For last names beginning with ! U! "! #! $! or %! use a monograph for a tablet or capsule beginning with the letter &.

    Kanamycin Sulfate Capsules 'edium( ).)1* +,-. /))ml &pparatus 1( 1))rpm 0ime( 12 minutes Procedure( 3etermine the amount of 4anamycin dissol5ed by employing the procedure set forth in the assay! ma6ing any necessary modifications. 0olerance( not less that 72 8 of labeled amount of ,19+:;*1<11 is dissol5e in 12 minutes =) 3escribe the dissolution test you would suggest for an enteric>coated tablet. $ou may find some hints in the USP.

    We can do dissolution test by putting the tablet into acidic en5ironment! that is similar to the stomach acid ?e.g. ).1* +,-)! for couple of hours and then raise the P+ to P+ similar to intestine ?&bout ;.2 to 7.2) :) Which of your dosage forms has the lowest 8@S3 in weight 5ariation? ABplain why the process you used ga5e this result.

    0he tablets ha5e the lowest 8 @S3. 0his is because of the much more precise method of ma6ing tablets by the machine. 0his precise process will not be possible by other two methods because of manhandling errors! such as weight of capsules to be considered! filling of capsules! etc. 1) What is the reactionCinteraction between disodium A30& and calcium? *a=DA30&=> D ,a=D >> ,a=DA30&=> D =*aD ,ompleB formation ?chelation) 2) Why must the p+ of the titration be 6ept too high? ?+int( -oo6 at the p4a of A30&).

    We must 6eep the P+ high so that the A30& remains deprotonated ?4eep E5e charge on A30&) so that is can compleB with the calcium. 0he compleB can only form at higher P+. ;) What is the function of hydroBynaphthol blue?

    +ydroBynaphthol blue acts as an indicator for the total completion of the titration reaction! which is the completion of ,a=D>A30& compleB formation. 7) 3id your tablets pass the dissolution test? ABplain why or why not based on the formulation of your batch.

    <ur tablets failed the dissolution test. 0he tablets in our batch contained calcium carbonate /2 and magnesium stearate. Ft did not contain any ABplotab and thus did not ha5e any or 5ery less disintegrating capability. 0hus it only dissol5ed from the surface and not from inside! which was due to little ability of magnesium stearate to disintegrate.

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