Add the following:
Adipic Acid
»Adipic Acid contains not less than 99.0percent and not more than 101.0percent of C6H10O4,calculated on the dried basis.
Identification,
Infrared Absorption á197Kñ.
Melting range á741ñ:
between 151and 154.
Loss on drying á731ñ
Dry it at 105to constant weight:it loses not more than 0.2%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Limit of nitrates
Standard stock solution
Dissolve about 815mg of potassium nitrate in 500mLof water,and mix.
Standard solution
Dilute 1mLof the Standard stock solutionwith water to 10mL,and mix.Dilute 1mLof this solution with water to 50mLto obtain a solution containing 2ppm of nitrate.
Test solution
Transfer 5g of Adipic Acid to a 50-mLvolumetric flask.Dissolve in water,with heating,and dilute with water to volume.Allow to cool and crystallize,then pass through a sintered-glass filter.Wash the filter with water,and collect the filtrate and washings until a volume of 50mLis obtained.[NOTEThis solution is to be used in the tests for Chloride,Sulfate,Iron,and Heavy metals.]
Procedure
To 1.0mLof the Test solutionand to 1.5mLof the Standard solution,separately add 2mLof concentrated ammonia,0.5mLof manganese sulfate solution (1in 100),and 1mLof sulfanilamide solution (1in 100),and dilute with water to 20mL.Add 100mg of zinc powder,and cool in an ice bath for 30minutes,shaking periodically.Filter 10mLof the solution,cool in an ice bath,and then add 2.5mLof hydrochloric acid and 1mLof a naphthylethylenediamine dihydrochloride solution (1in 100).Allow to stand at room temperature for 15minutes:the color of the Test solutionis not darker than a concomitantly prepared Standard solution;the limit is 0.003%.The test is invalid if a concomitantly prepared blank solution (prepared using 1mLof water instead of 1mLof the Test solution)is darker than a solution containing 2mg of potassium permanganate per L.
Chloride á221ñ
A5-mLportion of the Test solutionfrom the Limit of nitratestest shows no more chloride than a corresponding 0.14-mLportion of 0.020Nhydrochloric acid:the limit is 0.02%.
Sulfate á221ñ
A5-mLportion of the Test solutionfrom the Limit of nitrates test shows no more sulfate than a corresponding 0.26-mLportion of 0.020Nsulfuric acid:the limit is 0.05%.
Iron á241ñ
Use a 10-mLportion of the Test solutionfrom the Limit of nitratestest:the limit is 0.001%.
Heavy metals,Method Iá231ñ:
0.001%.
Assay
Dissolve 60mg of Adipic Acid in 50mLof water.Add 0.2mLof phenolphthalein TS,and titrate with 0.1Nsodium hydroxide VSto a permanent pale pink endpoint.Each mLof 0.1Nsodium hydroxide is equivalent to 7.31mg of C6H10O4.NF23
Auxiliary Information
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28NF23Page 2950
Pharmacopeial Forum:Volume No.30(4)Page 1322
Phone Number:1-301-816-8379
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