{"id":19232,"date":"2025-10-24T16:14:57","date_gmt":"2025-10-24T09:14:57","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19232"},"modified":"2025-10-24T16:14:57","modified_gmt":"2025-10-24T09:14:57","slug":"norethisterone-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/norethisterone-tablets\/","title":{"rendered":"Norethisterone Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Progestogen.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Norethisterone Tablets contain Norethisterone.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<h3>Content of norethisterone, C<sub>20<\/sub>H<sub>26<\/sub>O<sub>2<\/sub><\/h3>\n<p>90.0 to 110.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n<p>(1) Crush one tablet in sufficient ethanol (96%) to produce a final solution containing approximately 0.035% w\/v of Norethisterone, warm to 50\u00b0 for 10 minutes, mix with the aid of ultrasound, allow to cool and centrifuge to obtain a clear<br \/>\nsupernatant liquid.<\/p>\n<p>(2) 0.035% w\/v of norethisterone BPCRS in ethanol (96%).<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use as the coating silica gel (Merck silica gel 60 plates are suitable).<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 20 \u03bcL of each solution.<\/p>\n<p>(d) Develop the plate to 10 cm.<\/p>\n<p>(e) After removal of the plate, dry in air, spray with a mixture of 30 volumes of methanol and 70 volumes of sulfuric acid and examine under ultraviolet light (365 nm).<\/p>\n<p>MOBILE PHASE<\/p>\n<p>20 volumes of ethyl acetate and 80 volumes of toluene.<\/p>\n<p>CONFIRMATION<\/p>\n<p>The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Uniformity of content<\/h3>\n<p>Tablets containing less than 2 mg and\/or less than 2% w\/w of Norethisterone comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the<br \/>\nfollowing solutions.<\/p>\n<p>(1) Disperse one tablet in 2 mL of water with the aid of ultrasound for 15 minutes, add sufficient methanol to produce 5 mL, centrifuge for 10 minutes and use the clear supernatant liquid.<\/p>\n<p>(2) 0.007% w\/v of norethisterone BPCRS in methanol (60%).<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 \u03bcm) (Spherisorb ODS 1 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 254 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>28 volumes of water and 72 volumes of methanol.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of C<sub>20<\/sub>H<sub>26<\/sub>O<sub>2<\/sub> in each tablet using the declared content of C<sub>20<\/sub>H<sub>26<\/sub>O<sub>2<\/sub> in norethisterone BPCRS.<\/p>\n<h2>ASSAY<\/h2>\n<h3>For tablets containing less than 2 mg and\/or less than 2% w\/w of Norethisterone<\/h3>\n<p>Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n<h3>For tablets containing 2 mg or more and 2% w\/w or more of Norethisterone<\/h3>\n<p>Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Mix a quantity of the powdered tablets containing 5 mg of Norethisterone in 10 mL of water with the aid of ultrasound for 15 minutes, add sufficient methanol to produce 25 mL, centrifuge for 10 minutes and use the supernatant liquid.<\/p>\n<p>(2) 0.02% w\/v of norethisterone BPCRS in methanol (60%).<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions described under Uniformity of content may be used.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of C<sub>20<\/sub>H<sub>26<\/sub>O<sub>2<\/sub> in the tablets using the declared content of C<sub>20<\/sub>H<sub>26<\/sub>O<sub>2<\/sub> in norethisterone BPCRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Norethisterone Tablets should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Progestogen. DEFINITION Norethisterone Tablets contain Norethisterone. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of norethisterone, C20H26O2 90.0 to 110.0% of the stated amount. IDENTIFICATION Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1) Crush one tablet in sufficient&#8230;<\/p>\n","protected":false},"author":2,"featured_media":19250,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19232"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19232\/revisions"}],"predecessor-version":[{"id":19252,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19232\/revisions\/19252"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19250"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}