{"id":22089,"date":"2025-10-29T15:41:21","date_gmt":"2025-10-29T08:41:21","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22089"},"modified":"2025-10-29T15:41:21","modified_gmt":"2025-10-29T08:41:21","slug":"verapamil-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/verapamil-injection\/","title":{"rendered":"Verapamil Injection"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Calcium channel blocker.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Verapamil Injection is a sterile solution of Verapamil Hydrochloride in Water for Injections.<\/p>\n<p>The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n<h3>Content of verapamil hydrochloride, C<sub>27<\/sub>H<sub>38<\/sub>N<sub>2<\/sub>O<sub>4<\/sub>,HCl<\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 210 to 400 nm.<\/p>\n<p>The UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2);<\/p>\n<p>the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Acidity<\/h3>\n<p>pH, 4.5 to 6.0, Appendix V L.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in the mobile phase.<\/p>\n<p>(1) Dilute a volume of the injection, if necessary, to produce a solution containing 0.125% w\/v of Verapamil Hydrochloride.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 50 volumes. Further dilute 1 volume to 10 volumes.<\/p>\n<p>(3) 0.005% w\/v of verapamil hydrochloride BPCRS and 0.005% w\/v of verapamil impurity I EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (12.5 cm \u00d7 4 mm) packed with end-capped octadecylsilyl silica gel for chromatography (3 \u03bcm) (Hypersil ODS is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 0.85 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 278 nm.<\/p>\n<p>(f) Inject 10 \u03bcL of each solution.<\/p>\n<p>(g) Allow the chromatography to proceed for 4 times the retention time of verapamil.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>1 volume of 2-heptylamine, 4.7 volumes of glacial acetic acid, 58 volumes of acetonitrile and 137 volumes of 0.01M sodium acetate.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the retention times relative to verapamil (retention time about 6 minutes) are: impurity I, about 0.9 and impurity M, about 2.4.<\/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 impurity I and verapamil is at least 2.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n<p>the sum of the areas of any secondary peaks is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%).<\/p>\n<p>Disregard any peak with an area less than half of the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/p>\n<p>(1) Dilute a volume of the injection, if necessary, to produce a solution containing 0.0125% w\/v of Verapamil Hydrochloride.<\/p>\n<p>(2) 0.0125% w\/v of verapamil hydrochloride BPCRS.<\/p>\n<p>(3) 0.005% w\/v of verapamil hydrochloride BPCRS and 0.005% w\/v of verapamil impurity I EPCRS.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions described under Related substances may be used.<\/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 impurity I and verapamil is at least 2.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of verapamil hydrochloride, C<sub>27<\/sub>H<sub>38<\/sub>N<sub>2<\/sub>O<sub>4<\/sub>,HCl, in the injection from the chromatograms obtained and using the declared content of C<sub>27<\/sub>H<sub>38<\/sub>N<sub>2<\/sub>O<sub>4<\/sub>,HCl in verapamil hydrochloride BPCRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Verapamil Injection should be protected from light.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include impurities D, E, F, G, I, J, K and M listed under Verapamil Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Calcium channel blocker. DEFINITION Verapamil Injection is a sterile solution of Verapamil Hydrochloride in Water for Injections. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of verapamil hydrochloride, C27H38N2O4,HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum&#8230;<\/p>\n","protected":false},"author":2,"featured_media":22100,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22089","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\/22089","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=22089"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22089\/revisions"}],"predecessor-version":[{"id":22102,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22089\/revisions\/22102"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22100"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22089"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22089"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22089"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}