(Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Vasopressin analogue; treatment of diabetes insipidus; nocturnal enuresis.<\/p>\n Desmopressin Tablets contain Desmopressin.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n Content of desmopressin, C46<\/sub>H64<\/sub>N14<\/sub>O12<\/sub>S2<\/sub><\/strong><\/p>\n 90.0 to 110.0% of the stated amount of the peptide.<\/p>\n In the test for Uniformity of content, the principal peak in the chromatogram obtained with solution<\/p>\n (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n Dissolution<\/strong><\/p>\n Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n TEST CONDITIONS<\/p>\n (a) Use Apparatus 2, rotating the paddle at 75 revolutions per minute.<\/p>\n (b) Use 500 mL of water as the medium.<\/p>\n PROCEDURE<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) After 45 minutes, withdraw a 20 mL sample of the medium and filter.<\/p>\n (2) Prepare a solution of desmopressin BPCRS in water with a final concentration equal to that expected for solution (1).<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n The chromatographic procedure described under Uniformity of content may be used.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the total content of desmopressin C46H64N14O12S2, in the medium using the declared content of C46H64N14O12S2 in desmopressin BPCRS.<\/p>\n Related substances<\/strong><\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions and the normalisation procedure:<\/p>\n (1) Shake a quantity of powdered tablets containing 0.5 mg with 1 mL of water to give a final concentration of 0.05% w\/v of the peptide.<\/p>\n (2) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 0.5 mL of water.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (12 cm x 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm).<\/p>\n (b) Use gradient elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 220 nm.<\/p>\n (f) Inject 50 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n Mobile phase A 0.067M mixed phosphate buffer solution pH 7.0.<\/p>\n Mobile phase B 10 volumes of acetonitrile for chromatography and 10 volumes of mobile phase A.<\/p>\n The retention time of desmopressin is about 16 minutes.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the two principal peaks is at least 3.4.<\/p>\n LIMITS the area of any secondary peak is not more than 2.0%;<\/p>\n the total area of any such peaks is not more than 4.0%.<\/p>\n Disregard any peak due to the solvent or with a relative amount less than 0.05%.<\/p>\n Uniformity of content<\/span><\/strong><\/p>\n Tablets containing less than 2 mg and\/or less than 2% w\/w of Desmopressin comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions:<\/p>\n (1) Add sufficient water to one tablet to produce a solution containing 0.01% w\/v of Desmopressin.<\/p>\n (2) 0.01% w\/v of desmopressin BPCRS in water.<\/p>\n (3) Dissolve the contents of a vial desmopressin impurity standard BPCRSin 0.5 mL of water.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (12 cm x 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2 ml per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 220 nm.<\/p>\n (f) Inject 50 \u03bcl of each solution.<\/p>\n MOBILE PHASE<\/p>\n 2 volumes of acetonitrile for chromatography and 8 volumes of 0.067M mixed phosphate buffer solution pH 7.0.<\/p>\n The retention time of desmopressin is about 5 minutes.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks at least 2.8.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C46<\/sub>H64<\/sub>N14<\/sub>O12<\/sub>S2 <\/sub>in each tablet from the chromatograms obtained and from the declared content of C46<\/sub>H64<\/sub>N14<\/sub>O12<\/sub>S2 <\/sub>in desmopressin BPCRS.<\/p>\n Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n Desmopressin Tablets should be protected from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) Action and use Vasopressin analogue; treatment of diabetes insipidus; nocturnal enuresis. DEFINITION Desmopressin Tablets contain Desmopressin. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of desmopressin, C46H64N14O12S2 90.0 to 110.0% of the stated amount of the peptide. IDENTIFICATION In the test for Uniformity of…<\/p>\n","protected":false},"author":4,"featured_media":12977,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-12981","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\/12981","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=12981"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12981\/revisions"}],"predecessor-version":[{"id":12984,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12981\/revisions\/12984"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12977"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12981"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12981"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12981"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
\n\n
\n Time (Minutes)<\/strong><\/td>\n Mobile phase A%<\/strong><\/td>\n Mobile phase B%<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n \n 0-4<\/td>\n 76<\/td>\n 24<\/td>\n isocratic<\/td>\n<\/tr>\n \n 4-18<\/td>\n 76\u219258<\/td>\n 24\u219242<\/td>\n linear gragident<\/td>\n<\/tr>\n \n 18-35<\/td>\n 58\u219248<\/td>\n 42\u219252<\/td>\n linear gragident<\/td>\n<\/tr>\n \n 35-40<\/td>\n 48\u219276<\/td>\n 52\u219224<\/td>\n linear gragident<\/td>\n<\/tr>\n \n 40-50<\/td>\n 76<\/td>\n 24<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\nIn the chromatogram obtained with solution (1):<\/p>\nASSAY<\/h2>\n
STORAGE<\/h2>\n