Milk of Bismuth
»Milk of Bismuth contains bismuth hydroxide and Bismuth Subcarbonate in suspension in water,and yields not less than 5.2percent and not more than 5.8percent (w/w)of bismuth trioxide (Bi2O3).
Bismuth Subnitrate 80g
Nitric Acid 120mL
Ammonium Carbonate 10g
Strong Ammonia Solution,
Purified Water,each,a sufficient
quantity,to make
1000mL
Mix the Bismuth Subnitrate with 60mLof Purified Water and 60mLof the Nitric Acid in a suitable container,and agitate,warming gently until solution is effected.Pour this solution,with constant stirring,into 5000mLof Purified Water containing 60mLof the Nitric Acid.Dilute 160mLof Strong Ammonia Solution with 4300mLof Purified Water in a glazed or glass vessel of at least 12,000-mLcapacity.Dissolve the Ammonium Carbonate in this solution,and then pour the bismuth solution quickly into it with constant stirring.Add sufficient 6Nammonium hydroxide,if necessary,to render the mixture distinctly alkaline,allow to stand until the precipitate has settled,then pour or siphon off the supernatant,and wash the precipitate twice with Purified Water,by decantation.Transfer the magma to a strainer of close texture,so as to provide continuous washing with Purified Water,the outlet tube being elevated to prevent the surface of the magma from becoming dry.When the washings no longer yield a pink color with phenolphthalein TS,drain the moist preparation,transfer to a graduated vessel,add sufficient Purified Water to make 1000mL,and mix.
NOTE—This method of preparation may be varied,provided the product meets the following requirements.
Packaging and storage— Preserve in tight containers,and protect from freezing.
Identification—
A: It responds to the tests for Bismuth á191ñand for Carbonate á191ñ.
B: Add 1mLof 3Nhydrochloric acid to 1mLof Milk of Bismuth:a clear solution is produced.Pour the clear solution into 10volumes of water:a white precipitate is formed.
Microbial limits á61ñ The total bacterial count does not exceed 100cfu per mLand the test for Escherichia coliis negative.
Water-soluble substances— Boil 10mLwith 90mLof water for 10minutes,cool,add water to make the total volume 100mL,mix,and filter.Evaporate 50mLof the filtrate to dryness,and ignite it gently:the weight of the residue does not exceed 5mg (0.1%).
Arsenic,Method Iá211ñ Evaporate 3.75mLon a steam bath to dryness,add 2mLof sulfuric acid,and heat until copious fumes of sulfur trioxide are evolved.The limit is 0.8ppm.
Lead— To 5mLadd warm nitric acid,dropwise,until it is just dissolved,and pour the solution into 50mLof water:a white precipitate may form.Filter,if necessary,evaporate the filtrate on a steam bath to 15mL,again filter,and to 10mLof the filtrate add an equal volume of 2Nsulfuric acid:no precipitate is formed.
Limit of alkalies and alkaline earths— Dissolve 2.0mLin 5mLof hydrochloric acid,dilute with water to 100mL,add hydrogen sulfide to precipitate the bismuth completely,and filter.To 50mLof the clear filtrate add 5drops of sulfuric acid,evaporate to dryness,and ignite:the weight of the residue does not exceed 3mg (0.3%).
Assay— Evaporate an accurately weighed quantity of Milk of Bismuth to dryness,and ignite the residue to constant weight.From the weight of the Bi2O3so obtained determine the percentage in the assay specimen.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 264
Phone Number:1-301-816-8251