Gelatin
»Gelatin is a product obtained by the partial hydrolysis of collagen derived from the skin,white connective tissue,and bones of animals.Gelatin derived from an acid-treated precursor is known as Type A,and Gelatin derived from an alkali-treated precursor is known as Type B.
Gelatin,where being used in the manufacture of capsules,or for the coating of tablets,may be colored with a certified color,may contain not more than 0.15percent of sulfur dioxide,and may contain a suitable concentration of sodium lauryl sulfate and suitable antimicrobial agents.
Packaging and storage— Preserve in well-closed containers in a dry place.
Identification—
A: Dissolve 1g of Gelatin in 100mLof hot water.To this solution add about 20mLof a mixture of 0.2Mpotassium dichromate and 3Nhydrochloric acid (4:1):a yellow precipitate is formed.
B: To a hot solution (0.2mg per mL)add tannic acid TS:turbidity is produced.
Microbial limits á61ñ— The total bacterial count does not exceed 1000cfu per g,and the tests for Salmonellaspecies and Escherichia coliare negative.
Residue on ignition á281ñ— Incinerate 5.0g without the use of sulfuric acid,but with the addition of 1.5to 2.0g of paraffin to avoid loss due to swelling,then finish ashing in a muffle furnace at 550for 15to 20hours:the weight of the residue does not exceed 2.0%.
Odor and water-insoluble substances— Ahot solution (1in 40)is free from any disagreeable odor,and when viewed in a layer 2cm thick is only slightly opalescent.
Sulfur dioxide— Dissolve 20.0g in 150mLof hot water in a flask having a round bottom and a long neck,add 5mLof phosphoric acid and 1g of sodium bicarbonate,and at once connect the flask with a condenser.[NOTE—Excessive foaming can be alleviated by the addition of a few drops of a suitable antifoaming agent.]Distill 50mL,receiving the distillate under the surface of 50mLof 0.1Niodine.Acidify the distillate with a few drops of hydrochloric acid,add 2mLof barium chloride TS,and heat on a steam bath until the liquid is nearly colorless.The precipitate of barium sulfate,if any,when filtered,washed,and ignited,weighs not more than 3mg,corresponding to not more than 0.004%of sulfur dioxide,correction being made for any sulfate that may be present in 50mLof the 0.1Niodine.Gelatin used in the manufacture of capsules or for the coating of tablets yields not more than 109.3mg of barium sulfate,corresponding to not more than 0.15%of sulfur dioxide.
Arsenic,Method Iá211ñ—
Pepsin solution— Dissolve 0.5g of pepsin in 80mLof 0.1Nhydrochloric acid,dilute with 0.1Nhydrochloric acid to 100mL,and mix.
Standard preparation— Transfer 3.0mLof Standard Arsenic Solutionto an arsine generator flask,and dilute with Pepsin solutionto 52mL.Add 3mLof hydrochloric acid and 4mLof isopropyl alcohol,and mix.
Test preparation— Mix 3.75g with 40mLof Pepsin solutionin an arsine generator flask.Heat cautiously to a temperature between 65and 70,and,while maintaining this temperature for 30minutes,sonicate the solution for 2minutes at each 10-minute interval of heating time.Cool,wash down the sides of the generator with Pepsin solution,and dilute with Pepsin solutionto 52mL.Add 3mLof hydrochloric acid and 4mLof isopropyl alcohol,and mix.
Procedure— Proceed as directed for Procedureexcept omit the addition of 20mLof 7Nsulfuric acid and 1mLof isopropyl alcohol to the Standard preparationand to the Test preparation.The resulting solution obtained from the Test preparationmeets the requirements of the test:the limit is 0.8ppm.
Heavy metals á231ñ— To the residue obtained in the test for Residue on ignitionadd 2mLof hydrochloric acid and 0.5mLof nitric acid,and evaporate on a steam bath to dryness.To the residue add 1mLof 1Nhydrochloric acid and 15mLof water,and warm for a few minutes.Filter,and wash with water to make the filtrate measure 100mL.Dilute 8mLof the solution with water to 25mL:the limit is 0.005%.
Auxiliary Information— Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3009
Phone Number:1-301-816-8323