Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n 5-Alpha reductase inhibitor; treatment of benign prostatic hyperplasia.<\/p>\n Finasteride Tablets contain Finasteride. They are coated.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n Content of finasteride, C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub><\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. In the test for Dissolution, the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to finasteride in the chromatogram obtained with solution (2).<\/p>\n B. In the test for Uniformity of content, the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to finasteride in the chromatogram obtained with solution (2).<\/p>\n Dissolution<\/strong><\/p>\n Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n (a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n (b) Use 900 mL of water, at a temperature of 37\u00b0, as the medium.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) After 45 minutes withdraw a 10 mL sample of the medium and filter. Use the filtered medium.<\/p>\n (2) A suitable solution of finasteride BPCRS in a mixture of 3 volumes of water and 7 volumes of acetonitrile.<\/p>\n (a) Use a stainless steel column (5 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 \u03bcm) (Hypersil ODS is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use a column temperature of 45\u00b0.<\/p>\n (e) Use a detection wavelength of 220 nm.<\/p>\n (f) Inject 200 \u03bcL of each solution.<\/p>\n 21 volumes of water and 29 volumes of acetonitrile.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (2), the symmetry factor of the peak corresponding to finasteride is less than 2.0.<\/p>\n Calculate the content of C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub> in the medium from the chromatograms obtained using the declared content of C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub> in finasteride BPCRS.<\/p>\n Related substances<\/strong><\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Add 30 mL of a mixture of equal volumes of acetonitrile and water to a quantity of powdered tablets containing 100 mg of Finasteride, dilute to 50 mL with the same mixture of solvents, centrifuge and filter the supernatant liquid (0.2%).<\/p>\n (2) Dilute 2 volumes of solution (1) to 100 volumes with a mixture of equal volumes of acetonitrile and water, dilute 1 volume of this solution to 10 volumes with a mixture of equal volumes of acetonitrile and water.<\/p>\n (3) 0.2% w\/v of finasteride for peak identification EPCRS in a mixture of equal volumes of acetonitrile and water.<\/p>\n (4) Dilute 25 volumes of solution (2) to 100 volumes with equal volumes of acetonitrile and water.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.0 mm) packed with base-deactivated, end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil BDS is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use a column temperature of 60\u00b0.<\/p>\n (e) Use a detection wavelength of 210 nm.<\/p>\n (f) Inject 50 \u03bcL of each solution.<\/p>\n When the chromatograms are recorded using the prescribed conditions the retention time of finasteride is about 28 minutes. The retention times relative to finasteride are: impurity A, about 0.9; impurity B, about 1.2; impurity C, about 1.4.<\/p>\n For solution (1) allow the chromatography to run for twice the retention time of the finasteride peak.<\/p>\n 10 volumes of acetonitrile, 10 volumes of tetrahydrofuran and 80 volumes of water.<\/p>\n The test is not valid, unless in the chromatogram obtained with solution (3), the peak-to-valley ratio between finasteride impurity A and finasteride is at least 2.5.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n identify any peak due to finasteride impurity A and multiply the peak area by a correction factor of 2.4;<\/p>\n any peak corresponding to finasteride impurity A is not greater than 1.5 times the area of the principal peak in solution (2) (0.3%);<\/p>\n the area of any peak corresponding to finasteride impurity B is not greater than 1.5 times the area of the principal peak in solution (2) (0.3%);<\/p>\n the area of any peak corresponding to finasteride impurity C is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n the area of any other secondary peak is not greater than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%);<\/p>\n the sum of the areas of any secondary peaks is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.6%).<\/p>\n Disregard any peak with an area less than 0.25 times the area of the peak due to finasteride in the chromatogram obtained with solution (2) (0.05%).<\/p>\n Uniformity of content<\/strong><\/p>\n Tablets containing less than 2 mg and\/or less than 2% w\/w of Finasteride comply with the requirements stated under<\/p>\n Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 3 volumes of water and 7 volumes of acetonitrile (solvent A).<\/p>\n (1) Add 2.5 mL of water to one tablet, shake with the aid of ultrasound until the tablet is completely dispersed. Add 35 mL of solvent A mix with the aid of ultrasound for a further 30 minutes. Cool to room temperature, dilute to 50 mL with solvent A, centrifuge and use the clear supernatant liquid.<\/p>\n (2) A suitable solution of finasteride BPCRS in solvent A.<\/p>\n (a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil ODS is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use a column temperature of 45\u00b0.<\/p>\n (e) Use a detection wavelength of 240 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n Equal volumes of acetonitrile and 0.0025M of orthophosphoric acid.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (2), the symmetry factor of the peak due to finasteride is less than 2.0.<\/p>\n Calculate the content of C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub> in each tablet using the declared content of C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub> in finasteride BPCRS.<\/p>\n For tablets containing less than 2 mg and\/or less than 2% w\/w of Finasteride<\/strong><\/p>\n Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n For tablets containing 2 mg or more and 2% w\/w or more of Finasteride<\/strong><\/p>\n Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 3 volumes of water and 7 volumes of acetonitrile (solvent A).<\/p>\n (1) Add 25 mL of water to a quantity of the powdered tablets containing 50 mg of Finasteride, add 350 mL of solvent A, mix with the aid of ultrasound for 30 minutes. Allow to attain room temperature and dilute to 500 mL with solvent A, centrifuge and use the clear supernatant liquid.<\/p>\n (2) 0.010% w\/v of finasteride BPCRS in solvent A.<\/p>\n The chromatographic conditions described under Uniformity of content may be used.<\/p>\n The assay is not valid unless, in the chromatogram obtained with solution (2), the symmetry factor of the peak due to finasteride is less than 2.0.<\/p>\n Calculate the content of C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub> in the tablets from the chromatograms obtained and using the declared content of C23<\/sub>H36<\/sub>N2<\/sub>O2<\/sub> in finasteride BPCRS.<\/p>\n The impurities limited by the requirements of this monograph include those listed in the monograph for Finasteride.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use 5-Alpha reductase inhibitor; treatment of benign prostatic hyperplasia. DEFINITION Finasteride Tablets contain Finasteride. They are coated. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of finasteride, C23H36N2O2 95.0 to 105.0% of the stated amount. IDENTIFICATION A. In the…<\/p>\n","protected":false},"author":5,"featured_media":13796,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-13793","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\/13793","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=13793"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13793\/revisions"}],"predecessor-version":[{"id":13808,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13793\/revisions\/13808"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/13796"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=13793"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=13793"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=13793"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
TEST CONDITIONS<\/h3>\n
PROCEDURE<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
LIMITS<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
IMPURITIES<\/h2>\n