{"id":19013,"date":"2025-10-24T14:02:54","date_gmt":"2025-10-24T07:02:54","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19013"},"modified":"2025-10-24T14:02:54","modified_gmt":"2025-10-24T07:02:54","slug":"nitrazepam-oral-suspension","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nitrazepam-oral-suspension\/","title":{"rendered":"Nitrazepam Oral Suspension"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Benzodiazepine.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Nitrazepam Oral Suspension is a suspension of Nitrazepam in a suitable flavoured vehicle.<\/p>\n<p>The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n<h3>Content of nitrazepam, C<sub>15<\/sub>H<sub>11<\/sub>N<sub>3<\/sub>O<sub>3<\/sub><\/h3>\n<p>90.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n<p>(1) Shake a quantity of the oral suspension containing 2.5 mg of Nitrazepam with 10 mL of acetonitrile, centrifuge and use the supernatant liquid.<\/p>\n<p>(2) 0.025% w\/v of nitrazepam BPCRS in methanol.<\/p>\n<p>(3) 0.025% w\/v each of nitrazepam BPCRS and diazepam BPCRS in methanol.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use as the coating silica gel.<\/p>\n<p>(b) Use the mobile phase as described below.<\/p>\n<p>(c) Apply 10 \u03bcL of each solution.<\/p>\n<p>(d) Develop the plate to 15 cm.<\/p>\n<p>(e) After removal of the plate, dry in air, spray with dilute potassium iodobismuthate solution and examine in daylight.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>5 volumes of concentrated ammonia, 10 volumes of methanol and 85 volumes of ethyl acetate.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/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<p>B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<p>Carry out the following tests protected from light.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Shake a quantity of the oral suspension containing 5 mg of Nitrazepam with 60 mL of acetonitrile, add sufficient acetonitrile to produce 100 mL and filter.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes with acetonitrile.<\/p>\n<p>(3) 0.01% w\/v of nitrazepam BPCRS and 0.0002% w\/v of clonazepam BPCRS in acetonitrile.<\/p>\n<p>(4) Dilute 1 volume of solution (2) to 10 volumes with acetonitrile.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.0 mm) packed with octylsilyl silica gel for chromatography (5 \u03bcm) (Licrospher RP8 is suitable) and a stainless steel guard column (4 mm \u00d7 2 mm) packed with octylsilyl silica gel for chromatography (5 \u03bcm) (Phenomenex C8 is suitable).<\/p>\n<p>(b) Use gradient 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 a column temperature of 40\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 270 nm.<\/p>\n<p>(f) Inject 10 \u03bcL of each solution.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>Mobile phase A: 0.05M sodium dihydrogen orthophosphate, adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n<p>Mobile phase B: 20 volumes of mobile phase A and 80 volumes of acetonitrile.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-19021\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nitrazepam-Oral-Suspension-300x163.jpg\" alt=\"Nitrazepam Oral Suspension\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nitrazepam-Oral-Suspension-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nitrazepam-Oral-Suspension-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nitrazepam-Oral-Suspension-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Nitrazepam-Oral-Suspension.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>When the chromatograms are recorded under the prescribed conditions the retention times relative to nitrazepam (retention time about 9 minutes) are: impurity A, about 1.3 and impurity B, about 1.6.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to nitrazepam and clonazepam is at least 1.3.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak corresponding to impurity A is not greater than 1.8 times the area of the principal peak in the chromatogram obtained with solution (2) (1.8%);<\/p>\n<p>the area of any peak corresponding to impurity B is not greater than 3.2 times the area of the principal peak in the chromatogram obtained with solution (2) (3.2%);<br \/>\nthe area of any other secondary peak is not greater than half of the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n<p>the sum of the areas of all secondary peaks is not greater than 6 times the area of the principal peak in the chromatogram obtained with solution (2) (6%).<\/p>\n<p>Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Add a weighed quantity of the oral suspension containing 12.5 mg of Nitrazepam to 25 mL of water, extract with three 50-mL quantities of chloroform, filtering each extract through phase-separating paper and add sufficient chloroform to produce 200 mL.<\/p>\n<p>(2) 0.00625% w\/v of nitrazepam BPCRS in chloroform.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (20 cm \u00d7 4.6 mm) packed with silica gel for chromatography (5 \u03bcm) (Lichrosorb or Partisil is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2 mL per minute.<\/p>\n<p>(d) Use a column temperature of 40\u00b0.<\/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>10 volumes of absolute ethanol and 90 volumes of n-hexane.<\/p>\n<p>Under the prescribed conditions the retention time of the peak due to nitrazepam is about 8 minutes.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of C<sub>15<\/sub>H<sub>11<\/sub>N<sub>3<\/sub>O<sub>3<\/sub>, weight in volume, using the declared content of C<sub>15<\/sub>H<sub>11<\/sub>N<sub>3<\/sub>O<sub>3<\/sub> in nitrazepam BPCRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Nitrazepam Oral Suspension should be protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Nitrazepam.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Benzodiazepine. DEFINITION Nitrazepam Oral Suspension is a suspension of Nitrazepam in a suitable flavoured vehicle. The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Content of nitrazepam, C15H11N3O3 90.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the method for thin-layer chromatography, Appendix&#8230;<\/p>\n","protected":false},"author":2,"featured_media":19020,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19013","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\/19013","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=19013"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19013\/revisions"}],"predecessor-version":[{"id":19023,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19013\/revisions\/19023"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19020"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19013"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19013"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19013"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}