{"id":13571,"date":"2025-10-13T22:43:40","date_gmt":"2025-10-13T15:43:40","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=13571"},"modified":"2025-10-14T16:16:48","modified_gmt":"2025-10-14T09:16:48","slug":"famotidine-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/famotidine-tablets\/","title":{"rendered":"Famotidine Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Histamine H<sub>2<\/sub> receptor antagonist; treatment of peptic ulceration.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Famotidine Tablets contain Famotidine.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<p>Content of famotidine, C<sub>8<\/sub>H<sub>15<\/sub>N<sub>7<\/sub>O<sub>2<\/sub>S<sub>3<\/sub><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak in the chromatogram obtained with solution (2).<br \/>\nB. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<br \/>\n(1) Shake a quantity of the powdered tablets containing 40 mg of Famotidine with 4 mL of glacial acetic acid with the aid of ultrasound, dilute to 10 mL with the same solvent, centrifuge and use the clear supernatant liquid.<br \/>\n(2) 0.4% w\/v of famotidine BPCRS in glacial acetic acid.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use as the coating silica gel F254 (Fischer Silica Gel GF plates are suitable).<br \/>\n(b) Use the mobile phase as described below.<br \/>\n(c) Apply 10 \u03bcL of each solution.<br \/>\n(d) Develop the plate to 15 cm.<br \/>\n(e) After removal of the plate, allow it to dry in air and examine immediately under ultraviolet light (254 nm).<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>2 volumes of 13.5M ammonia, 20 volumes of toluene, 25 volumes of methanol and 40 volumes of ethyl acetate.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<p><strong>Dissolution<\/strong><\/p>\n<p>Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n<h3>TEST CONDITIONS<\/h3>\n<p>(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<br \/>\n(b) Use 900 mL of phosphate buffer pH 4.5, at a temperature of 37\u00b0, as the medium prepared in the following manner. Dissolve 13.61 g of potassium dihydrogen orthophosphate in water, adjust the pH of the solution with orthophosphoric acid or 1M potassium hydroxide as necessary and add sufficient water to produce 1000 mL.<\/p>\n<h3>PROCEDURE<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Withdraw a sample of the medium, filter and centrifuge at 2000 revolutions per minute for 20 minutes. Dilute, if necessary, with the dissolution medium to produce a solution expected to contain 0.001% w\/v of Famotidine.<br \/>\n(2) 0.001% w\/v of famotidine BPCRS in the dissolution medium.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Inertsil ODS-2 is suitable).<br \/>\n(b) Use isocratic elution and the mobile phase described below.<br \/>\n(c) Use a flow rate of 1.4 mL per minute.<br \/>\n(d) Use a column temperature of 40\u00b0.<br \/>\n(e) Use a detection wavelength of 275 nm.<br \/>\n(f) Inject 50 \u03bcL of each solution.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>7 volumes of acetonitrile and a mixture of 93 volumes of 0.1M sodium acetate containing 0.1% v\/v of triethylamine the pH adjusted to 6.0 with glacial acetic acid.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the total content of famotidine, C<sub>8<\/sub>H<sub>15<\/sub>N<sub>7<\/sub>O<sub>2<\/sub>S<sub>3<\/sub>, in the medium using the declared content of C<sub>8<\/sub>H<sub>15<\/sub>N<sub>7<\/sub>O<sub>2<\/sub>S<sub>3 <\/sub>in famotidine BPCRS.<\/p>\n<p><strong>Related substances<\/strong><\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>Solution A: 0.05M potassium dihydrogen orthophosphate adjusted to pH 6.0 with 1M potassium hydroxide.<\/p>\n<p>(1) Add 200 mL of solution A to a quantity of whole tablets containing 0.2 g of Famotidine, mix with the aid of ultrasound for 5 minutes, add about 200 mL of methanol, shake for 60 minutes and add sufficient solution A to produce 500 mL.<br \/>\n(2) Dilute 1 volume of solution (1) to 100 volumes with solution A.<br \/>\n(3) Dilute 1 volume of solution (1) to 10 volumes with solution A and dilute 1 volume of the resulting solution to 50 volumes with solution A.<br \/>\n(4) Add 40 mL of acetonitrile to a mixture of 2 mg of each of famotidine impurity C BPCRS, famotidine degradation impurity 1 BPCRS (famotidine impurity F) and famotidine impurity D EPCRS (famotidine degradation impurity 2) mix with the aid of ultrasound for 2 minutes, cool, add 40 mL of methanol and sufficient solution A to produce 200 mL. Dilute 1 volume of the resulting solution to 5 volumes with solution A.<br \/>\n(5) Dissolve 8 mg of famotidine BPCRS in 15 mL of solution A with the aid of ultrasound, cool and add sufficient solution A to produce 20 mL (solution B); to 1 mL of this solution add 0.05 mL of hydrogen peroxide solution (10 vol) (generates famotidine degradation impurity 3).<br \/>\n(6) Dilute 1 volume of solution B with 100 volumes of solution A and further dilute a suitable volume with an equal volume of solution (4).<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Dissolution may be used.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the relative retention(s) with reference to famotidine (retention time about 5 minutes) are: famotidine degradation impurity 3, about 0.4; famotidine impurity F, about 0.6; famotidine impurity C, about 0.7; and famotidine impurity D, about 1.2.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, in the chromatogram obtained with solution (6):<\/p>\n<p>the resolution between the peaks due to famotidine impurity C and famotidine is at least 1.4;<\/p>\n<p>the resolution between the peaks due to famotidine and famotidine impurity D is at least 1.4.<\/p>\n<p>If this resolution is not achieved adjust the content of acetonitrile or decrease the concentration of sodium acetate in the mobile phase.<\/p>\n<h3>LIMITS<\/h3>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the areas of any peaks corresponding to impurities C, D, or F are not greater than the areas of the corresponding peaks in<\/p>\n<p>the chromatogram obtained with solution (4) (0.5% of each);<\/p>\n<p>the area of any peak corresponding to famotidine degradation impurity 3 is not greater than the area of the peak in the chromatogram obtained with solution (2) (1%);<\/p>\n<p>the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.2%).<\/p>\n<p>the sum of the areas of any secondary peaks is not greater than 2.5 times the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n<p>Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (3) (0.05%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>Solution A: 0.05M potassium dihydrogen orthophosphate adjusted to pH 6.0 with 1M potassium hydroxide.<\/p>\n<p>(1) Add 200 mL of solution A to a quantity of whole tablets containing 0.2 g of Famotidine, mix with the aid of ultrasound for 5 minutes, add about 200 mL of methanol, shake for 60 minutes and add sufficient solution A to produce 500 mL. Dilute 1 volume of this solution to 5 volumes with solution A.<br \/>\n(2) Dissolve 8 mg of famotidine BPCRS in 4 mL of methanol, mix with the aid of ultrasound for 5 minutes and add sufficient solution A to produce 20 mL. Dilute 1 volume of this solution to 5 volumes with solution A.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Dissolution may be used.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>8<\/sub>H<sub>15<\/sub>N<sub>7<\/sub>O<sub>2<\/sub>S<sub>3<\/sub> in the tablets using the declared content of C<sub>8<\/sub>H<sub>15<\/sub>N<sub>7<\/sub>O<sub>2<\/sub>S<sub>3<\/sub> in famotidine BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include impurities C, D, and F listed under Famotidine and the following:<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-13580\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Famotidine-Tablets-1.jpg\" alt=\"Famotidine Tablets\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Famotidine-Tablets-1.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Famotidine-Tablets-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Famotidine-Tablets-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Famotidine-Tablets-1-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<p>3. 3-[2-(Diaminomethyleneamino)-1,3-thiazol-4-ylmethylsulfinyl]-N-sulfamoylpropanamidine.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Histamine H2 receptor antagonist; treatment of peptic ulceration. DEFINITION Famotidine Tablets contain Famotidine. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of famotidine, C8H15N7O2S3 95.0 to 105.0% of the stated amount. IDENTIFICATION A. In the Assay, the chromatogram obtained with solution (1) shows a peak&#8230;<\/p>\n","protected":false},"author":5,"featured_media":13573,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-13571","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\/13571","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=13571"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13571\/revisions"}],"predecessor-version":[{"id":14124,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13571\/revisions\/14124"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/13573"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=13571"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=13571"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=13571"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}