»Prepare Bentonite Magma as follows:
Sprinkle the Bentonite,in portions,upon 800g of hot purified water,allowing each portion to become thoroughly wetted without stirring.Allow it to stand with occasional stirring for 24hours.Stir until a uniform magma is obtained,add Purified Water to make 1000g,and mix.
The Magma may be prepared also by mechanical means such as by use of a blender,as follows.Place about 500g of Purified Water in the blender,and while the machine is running,add the Bentonite.Add Purified Water to make up to about 1000g or up to the operating capacity of the blender.Blend the mixture for 5to 10minutes,add Purified Water to make 1000g,and mix.
Packaging and storage Preserve in tight containers.
Microbial limits á61ñ It meets the requirements of the test for absence of Escherichia coli.
Organic volatile impurities,Method IVá467ñ: meets the requirements.
Auxiliary Information Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content