Aminosalicylic Acid Tablets
»Aminosalicylic Acid Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of aminosalicylic acid (C7H7NO3).
Packaging and storage— Preserve in tight,light-resistant containers,at a temperature not exceeding 30.
Identification— Macerate a portion of powdered Tablets,equivalent to about 2g of aminosalicylic acid,with 50mLof a mixture of 1volume of acetone and 2volumes of chloroform,and filter.Evaporate the filtrate with the aid of a current of warm air to dryness:the residue so obtained responds to Identificationtests Band Cunder Aminosalicylic Acid.
Dissolution á711ñ—
Medium: pH7.5phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of C7H7NO3dissolved,employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances— Not less than 75%(Q)of the labeled amount of C7H7NO3is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Limit of m-aminophenol—
Mobile phase andInternal standard solution— Prepare as directed in the Assayunder Aminosalicylic Acid.
Standard solution and Chromatographic system— Prepare as directed in the test for Limit of m-aminophenolunder Aminosalicylic Acid.
Test solution— Use the Assay preparation,prepared as directed in the Assay.
Procedure— Proceed as directed for Procedurein the test for Limit of m-aminophenolunder Aminosalicylic Acid.Calculate the percentage of m-aminophenol,in relation to the quantity of aminosalicylic acid in the portion of Tablets taken by the formula:
100(C/W)(RU/RS),
in which Cis the concentration,in µg per mL,of USPm-Aminophenol RSin the Standard solution;Wis the quantity of aminosalicylic acid,in mg,in the portion of Tablets taken,as determined in the Assay;and RUand RSare the ratios of the response of the m-aminophenol peak to the response of the sulfanilamide peak obtained from the Test solutionand the Standard solution;respectively:not more than 1.0%of m-aminophenol is found.
Assay—
Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Aminosalicylic Acid.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 500mg of aminosalicylic acid,to a 100-mLlow-actinic volumetric flask.Add 50mLof Mobile phase,and shake for about 5minutes.Dilute with Mobile phaseto volume,and mix.Filter,and transfer 10.0mLof the clear filtrate to a 100-mLlow-actinic volumetric flask containing 10.0mLof Internal standard solution,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Aminosalicylic Acid.Calculate the quantity,in mg,of aminosalicylic acid (C7H7NO3)in the portion of Tablets taken by the formula:
1000C(RU/RS),
in which Cis the concentration,in mg per mL,of USP Aminosalicylic Acid RSin the Standard preparation;and RUand RSare the ratios of the response of the aminosalicylic acid peak to the response of the acetaminophen peak obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 134
Phone Number:1-301-816-8394
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