Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Iodinated contrast medium.<\/p>\n Iopamidol Injection is a solution of Iopamidol in Water for Injections with or without excipients.<\/p>\n The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n Content of iopamidol, C17<\/sub>H22<\/sub>I3<\/sub>N3<\/sub>O8<\/sub>:<\/strong> A. Dry 1 mL of the injection over phosphorus pentoxide at a pressure of 2 kPa for 16 hours. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of iopamidol (RS 441). Acidity or alkalinity<\/strong><\/p>\n pH, 6.5 to 7.5, Appendix V L.<\/p>\n Light absorption<\/p>\n The light absorption of a 4-cm layer of the injection, Appendix II B at 450 nm is not more than 0.120.<\/p>\n Free aromatic amines<\/p>\n The following solutions and reagents are stored in ice-water and protected from bright light.<\/p>\n Mix a volume of the injection containing 0.5 g of Iopamidol with water and add sufficient water to produce 20 mL.<\/p>\n Place the solution in ice-water, protected from light, for 5 minutes.<\/p>\n Add 1.0 mL of hydrochloric acid, mix and allow to stand for 5 minutes.<\/p>\n Add 1.0 mL of a 2% w\/v solution of sodium nitrite prepared immediately before use, mix and allow to stand for 5 minutes.<\/p>\n Add 1.0 mL of a 12% w\/v solution of ammonium sulfamate, swirl gently until gas liberation has ceased and allow to stand for 5 minutes.<\/p>\n Add 1.0 mL of a freshly prepared 0.1% w\/v solution of naphthylethylenediamine dihydrochloride and mix.<\/p>\n Remove from the ice-water and allow to stand for 10 minutes.<\/p>\n Add sufficient water to produce 25 mL and mix.<\/p>\n Immediately measure the absorbance at 500 nm, Appendix II B, using in the reference cell a solution prepared by treating 20 mL of water in the same manner.<\/p>\n The absorbance is not greater than that obtained by treating 20 mL of a 0.00125% w\/v solution of iopamidol impurity A EPCRS in water in the same manner and beginning at the words \u201cPlace the solution\u2026\u201d. (500 ppm).<\/p>\n Free iodine<\/p>\n Mix a volume of the injection containing 2.0 g of Iopamidol with water and add sufficient water to produce 25 mL.<\/p>\n Add 5 mL of toluene and 5 mL of dilute sulfuric acid, shake and centrifuge.<\/p>\n Any red colour in the upper phase is not more intense than that of the upper phase obtained in the same manner from a mixture of 22 mL of water, 2 mL of iodide standard solution (10 ppm I), 5 mL of dilute sulfuric acid, 1 mL of hydrogen peroxide solution (100 vol) and 5 mL of toluene (10 ppm).<\/p>\n Iodide<\/p>\n To 10 mL of the injection add sufficient water to produce 50 mL.<\/p>\n Add 2.0 mL of 0.001M potassium iodide.<\/p>\n Carry out the method for potentiometric titration, Appendix VIII B, using 0.001M silver nitrate VS, a silver indicator electrode and an appropriate reference electrode.<\/p>\n Subtract the volume of titrant corresponding to the 2.0 mL of 0.001M potassium iodide, determined by titrating a blank to which is added 2.0 mL of 0.001M potassium iodide, and use the residual value to calculate the iodide content.<\/p>\n 1 mL of 0.001M silver nitrate VS is equivalent to 126.9 \u00b5g of iodide.<\/p>\n Not more than 2.0 mL of 0.001M silver nitrate VS is required (40 ppm).<\/p>\n Related substances<\/strong><\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Mix a volume of the injection containing 0.5 g of Iopamidol with water and add sufficient water to produce 50 mL.<\/p>\n (2) 0.005% w\/v of iopamidol impurity H EPCRS in water.<\/p>\n (3) Dilute 1 volume of solution (1) to 500 volumes with water.<\/p>\n (4) To 200 volumes of solution (2) add 1 volume of solution (1) and add sufficient water to produce 500 volumes.<\/p>\n (5) 1.0% w\/v of iopamidol EPCRS in water.<\/p>\n (a) Use two stainless steel columns (25 cm \u00d7 4.6 mm) coupled in series and packed with phenylsilyl silica gel for chromatography (5 \u00b5m) (Zorbax SB-Phenyl 80 \u00c5 is suitable).<\/p>\n (b) Use gradient elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2.0 mL per minute.<\/p>\n (d) Use a column temperature of 60\u00b0.<\/p>\n (e) Use a detection wavelength of 240 nm.<\/p>\n (f) Inject 20 \u00b5L of each solution.<\/p>\n The retention time of iopamidol is about 15 minutes and the retention time of the peak due to impurity H is about 13 minutes. Impurity H and impurity I have identical retention times.<\/p>\n Mobile phase A: water.<\/p>\n Mobile phase B: Equal volumes of acetonitrile and water.<\/p>\n Equilibrate the column for at least 20 minutes with mobile phase A.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution factor between the peaks corresponding to iopamidol and iopamidol impurity H is at least 2.0.<\/p>\n If necessary, adjust the composition of the mobile phase or the time programme of the gradient.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n The area of any peak corresponding to impurity H or impurity I is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (3) (0.5%).<\/p>\n The area of any other secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n The sum of the areas of any secondary peaks other than impurities H and I is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.2%).<\/p>\n 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 Sterility<\/strong><\/p>\n Complies with the test for sterility, Appendix XVI A.<\/p>\n Bacterial endotoxins<\/strong><\/p>\n The endotoxin limit concentration is 0.7 IU per mL, Appendix XIV C.<\/p>\n Mix a volume of the injection containing 0.220 g of Iopamidol with water and add sufficient water to produce 20 mL.<\/p>\n Add 5 mL of strong sodium hydroxide solution, 1 g of zinc powder and a few glass beads.<\/p>\n Boil under a reflux condenser for 30 minutes.<\/p>\n Allow to cool and rinse the condenser with 20 mL of water, adding the rinsings to the flask.<\/p>\n Filter through a sintered-glass filter and wash the filter with several quantities of water.<\/p>\n Collect the filtrate and washings.<\/p>\n Add 5 mL of glacial acetic acid and titrate immediately with 0.1M silver nitrate VS.<\/p>\n Carry out the method for potentiometric titration, Appendix VIII B, using a suitable electrode system such as silver-silver chloride.<\/p>\n Each mL of 0.1M silver nitrate VS is equivalent to 25.90 mg of C17H22I3N3O8.<\/p>\n Iopamidol Injection should be protected from light.<\/p>\n The quantity of active ingredient is stated in terms of Iopamidol and as the equivalent amount of iodine.<\/p>\n The impurities limited by the requirements of this monograph include those listed under Iopamidol.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Iodinated contrast medium. DEFINITION Iopamidol Injection is a solution of Iopamidol in Water for Injections with or without excipients. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of iopamidol, C17H22I3N3O8: 95.0 to 105.0% of the stated amount….<\/p>\n","protected":false},"author":5,"featured_media":21431,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21425","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\/21425","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=21425"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21425\/revisions"}],"predecessor-version":[{"id":21450,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21425\/revisions\/21450"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21431"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21425"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21425"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21425"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
\n95.0 to 105.0% of the stated amount.<\/p>\nIDENTIFICATION<\/h2>\n
\nB. In the test for Related substances, the principal peak in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (5).<\/p>\nTESTS<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
\n\n
\n \nTime (Minutes)<\/th>\n Mobile phase A (%v\/v)<\/th>\n Mobile phase B (%v\/v)<\/th>\n Comment<\/th>\n<\/tr>\n<\/thead>\n \n 0\u201318<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n \n 18\u201340<\/td>\n 100\u219262<\/td>\n 0\u219238<\/td>\n linear gradient<\/td>\n<\/tr>\n \n 40\u201345<\/td>\n 62\u219250<\/td>\n 38\u219250<\/td>\n linear gradient<\/td>\n<\/tr>\n \n 45\u201350<\/td>\n 50\u2192100<\/td>\n 50\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n \n 50\u201360<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/h3>\n
LIMITS<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n
IMPURITIES<\/h2>\n