Esterified Estrogens Tablets
» Esterified Estrogens Tablets contain not less than 90.0 percent and not more than 115.0 percent of the labeled amount of esterified estrogens as the total of sodium estrone sulfate and sodium equilin sulfate. The ratio of sodium equilin sulfate to sodium estrone sulfate is not less than 0.071 and not more than 0.20.
Packaging and storage Preserve in well-closed containers.
USP Reference standards 11
Simulated intestinal fluid Dissolve 6.8 g of monobasic potassium phosphate in 250 mL of water, mix, and add 190 mL of 0.2 N sodium hydroxide and 400 mL of water. Add 10.0 g of pancreatin, mix, and adjust the resulting solution with 0.2 N sodium hydroxide to a pH of 7.5 ± 0.1. Dilute with water to 1000 mL.
Procedure Place 1 Tablet in each of the six tubes of the basket, and immerse the basket in water at 25 ± 0.5 for 5 minutes to remove the coating. Add a disk to each tube, and operate the apparatus using simulated gastric fluid TS, maintained at 37 ± 2, as the immersion fluid. After 30 minutes in simulated gastric fluid TS, lift the basket from the fluid, and observe the Tablets: all the Tablets have disintegrated. If all the Tablets have not disintegrated completely, substitute Simulated intestinal fluid, maintained at 37 ± 2, as the immersion fluid, and continue the test so that the total period of time, including previous exposure to water and simulated gastric fluid TS, does not exceed 90 minutes.
Uniformity of dosage units Assay 10 individual Tablets as directed in the Assay, and calculate the average content of esterified estrogens, as the average of the total contents of sodium estrone sulfate and sodium equilin sulfate, in the 10 Tablets. The requirements are met if the content of each of the Tablets is not less than 85.0 percent and not more than 115.0 percent of the average content of esterified estrogens. If the content of not more than 2 Tablets falls outside the range of 85.0 percent to 115.0 percent of the average content but not outside the range of 75.0 percent to 125.0 percent, assay an additional 20 Tablets. The requirements are met if the content of not more than 2 of the 30 Tablets falls outside the limits of 85.0 percent and 115.0 percent of the average, and no unit is outside the range of 75.0 percent to 125.0 percent of the average content.
Assay Weigh and finely powder not less than 20 Tablets. Using a suitable portion of the powder, proceed as directed in the Assay under Conjugated Estrogens.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3116Pharmacopeial Forum: Volume No. 37(3)