(a mee'' noe sa lis' i late soe' dee um).
Benzoic acid, 4-amino-2-hydroxy-, monosodium salt, dihydrate.
Monosodium 4-aminosalicylate dihydrate [6018-19-5].
Anhydrous 175.12 [133-10-8].
» Aminosalicylate Sodium contains not less than 98.0 percent and not more than 101.0 percent of C7H6 NNaO3, calculated on the anhydrous basis.
[CautionPrepare solutions of Aminosalicylate Sodium within 24 hours of administration. Under no circumstances use a solution if its color is darker than that of a freshly prepared solution. ]
Packaging and storage Preserve in tight, light-resistant containers, protected from excessive heat.
USP Reference standards 11
Clarity and color of solution One g dissolves in 10 mL of water to give a clear solution that has not more than a faint yellow color. One g dissolves in a freshly prepared mixture of 5 mL of nitric acid and 45 mL of water to give a clear solution that has not more than a slight color.
A: Dissolve 250 mg in 3 mL of 1 N sodium hydroxide, transfer to a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer a 5-mL aliquot to a 250-mL volumetric flask containing 12.5 mL of pH 7 phosphate buffer (see under Buffer Solutions in the section Reagents, Indicators, and Solutions), dilute with water to volume, and mix. This solution, when compared in a suitable spectrophotometer against a blank of the same buffer in the same concentration, exhibits absorbance maxima at 265 ± 2 nm and 299 ± 2 nm, and the ratio A265/A299 is between 1.50 and 1.56.
B: Place about 1 g in a small, round-bottom flask, and add 10 mL of acetic anhydride. Heat the flask on a steam bath for 30 minutes, add 40 mL of water, mix, filter, cool, and allow to stand until the diacetyl derivative has crystallized. Collect the precipitate on a filter, wash with water, and dry at 105 for 1 hour: the diacetyl derivative so obtained melts between 191 and 197.
C: Dissolve 50 mg in 5 mL of water, add 1 mL of 3 N hydrochloric acid, and filter if necessary. To the filtrate add 1 drop of ferric chloride TS: a violet color is produced.
D: A solution of it responds to the tests for Sodium 191.
pH 791: between 6.5 and 8.5, in a solution (1 in 50).
Water, Method I 921: between 16.0% and 18.0%.
Chloride 221 Dissolve 0.50 g in a mixture of 5 mL of nitric acid and 15 mL of water: the solution shows no more chloride than corresponds to 0.30 mL of 0.020 N hydrochloric acid (0.042%).
Heavy metals, Method II 231: 0.003%.
Limit of m-aminophenol
Internal standard solution, Standard preparation, and Chromatographic system Prepare as directed in the test for Limit of m-aminophenol under Aminosalicylic Acid.
Test preparation Use the Assay preparation, prepared as directed in the Assay.
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Test preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. The relative retention times are about 0.66 for sulfanilamide and 1.0 for m-aminophenol. Calculate the percentage of m-aminophenol, in relation to the quantity of aminosalicylate sodium in the portion of Aminosalicylate Sodium taken by the formula:
10(C / W)(RU / RS)in which C is the concentration, in µg per mL, of USP m-Aminophenol RS in the Standard preparation; W is the quantity of aminosalicylate sodium, in mg, in the portion of Aminosalicylate Sodium taken, as determined in the Assay; and RU and RS are the ratios of the response of the m-aminophenol peak to the response of the sulfanilamide peak obtained from the Test preparation and the Standard preparation, respectively: not more than 0.25% of m-aminophenol is found.
Hydrogen sulfide, sulfur dioxide, and amyl alcohol Dissolve about 500 mg in 5 mL of 1 N sodium hydroxide, add 6 mL of 3 N hydrochloric acid, and stir vigorously: no odor of hydrogen sulfide or sulfur dioxide is perceptible, and not more than a faint odor of amyl alcohols is perceptible. A piece of moistened lead acetate test paper held over the mixture does not become discolored.
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Aminosalicylic Acid.
Assay preparation Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Aminosalicylic Acid. Calculate the quantity of C7H6NNaO3, in mg, in the Aminosalicylate Sodium taken by the formula:
(175.12 / 153.14)(100C)(RU / RS)in which 175.12 and 153.14 are the molecular weights of anhydrous aminosalicylate sodium and aminosalicylic acid, respectively; C is the concentration, in mg per mL, of USP Aminosalicylic Acid RS in the Standard preparation; and RU and RS are the ratios of the response of the aminosalicylic acid peak to the response of the acetaminophen peak obtained from the Assay preparation and the Standard preparation; respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2177