Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Diamorphine Tablets<\/p>\n
General Notices<\/p>\n
Action and use\u00a0<\/strong><\/p>\n Opioid receptor agonist analgesic.<\/p>\n Diamorphine Tablets contain Diamorphine Hydrochloride.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n Content of diamorphine hydrochloride, C21<\/sub>H23<\/sub>NO5<\/sub>,HCl,H2<\/sub>O\u00a0<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n Shake a quantity of the powdered tablets containing 10 mg of Diamorphine Hydrochloride with 10 mL of dichloromethane, filter and evaporate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of diamorphine hydrochloride (RS 093).<\/p>\n Comply with the requirements in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n (a)\u2003Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n (b)\u2003Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003After 15 minutes withdraw a sample of the medium and filter. Use the filtered medium, diluted with water if necessary, to produce a solution expected to contain 0.0011% w\/v of Diamorphine Hydrochloride.<\/p>\n (2)\u20030.0011% w\/v of diamorphine hydrochloride BPCRS in the dissolution medium.<\/p>\n (a)\u2003Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u00b5m) (Spherisorb ODS2 is suitable).<\/p>\n (b)\u2003Use isocratic elution and the mobile phase described below.<\/p>\n (c)\u2003Use a flow rate of 1 mL per minute.<\/p>\n (d)\u2003Use a column temperature of 30\u00b0.<\/p>\n (e)\u2003Use a detection wavelength of 260 nm.<\/p>\n (f)\u2003Inject 250 \u00b5L of each solution.<\/p>\n 45 volumes of acetonitrile and 55 volumes of 0.01M sodium heptanesulfonate, containing 0.0075M N,N dimethyloctylamine, which has been adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n Calculate the total content of C21<\/sub>H23<\/sub>NO5<\/sub>,HCl,H2<\/sub>O in the medium from the chromatograms obtained and using the declared content of C21<\/sub>H23<\/sub>NO5<\/sub>,HCl,H2<\/sub>O in diamorphine hydrochloride BPCRS.<\/p>\n The amount of diamorphine hydrochloride released is not less than 75% (Q) of the stated amount.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Disperse a quantity powdered tablets containing 80 mg of Diamorphine Hydrochloride in 10 mL of water. (2)\u2003Dilute 1 volume of solution (1) to 100 volumes with water.<\/p>\n (3)\u2003Disperse a quantity of the powdered tablets to give a solution containing 0.1% w\/v of Diamorphine Hydrochloride in 0.01M sodium hydroxide; the solution should be freshly prepared.<\/p>\n (4)\u2003Dilute 1 volume of solution (2) to 10 volumes with water.<\/p>\n (a)\u2003Use a stainless steel column (12.5 cm \u00d7 4.6 mm) packed with octylsilyl silica gel for chromatography (5 \u00b5m) (Lichrospher RP-select B is suitable).<\/p>\n (b)\u2003Use isocratic elution and the mobile phase described below.<\/p>\n (c)\u2003Use a flow rate of 1 mL per minute.<\/p>\n (d)\u2003Use an ambient column temperature.<\/p>\n (e)\u2003Use a detection wavelength of 283 nm.<\/p>\n (f)\u2003Inject 50 \u00b5L of each solution.<\/p>\n (g)\u2003For solution (1), allow the chromatography to proceed for twice the retention time of the peak due to diamorphine.<\/p>\n 0.11% w\/v of sodium octanesulfonate in a mixture of 10 volumes of glacial acetic acid, 10 volumes of methanol, 115 volumes of acetonitrile and 365 volumes of water.<\/p>\n When the chromatograms are recorded under the prescribed conditions the retention time of diamorphine is about 20 minutes.<\/p>\n The chromatogram obtained with solution (3) exhibits two secondary peaks with retention times relative to the principal peak of about 0.23 (morphine) and 0.43 (6-O-acetyl-morphine). The test is not valid unless the resolution between the peaks due to morphine and 6-O-acetyl-morphine is at least 2.0.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to 6-O-acetylmorphine is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%);\u00a0the area of any other secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);\u00a0\u00a0the sum of the areas of any other secondary peaks is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n 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 Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Disperse a quantity of the powdered tablets containing 30 mg of Diamorphine Hydrochloride in water, dilute to 100 mL with water.<\/p>\n (2)\u20030.03% w\/v of diamorphine hydrochloride BPCRS in water.<\/p>\n The chromatographic conditions described under Dissolution may be used with an injection volume of 10 \u00b5L.<\/p>\n 45 volumes of acetonitrile and 55 volumes of 0.01M sodium heptanesulfonate, containing 0.0075M N,N dimethyloctylamine, which has been adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n Calculate the content of C21<\/sub>H23<\/sub>NO5<\/sub>,HCl,H2<\/sub>O in the tablets using the declared content of C21<\/sub>H23<\/sub>NO5<\/sub>,HCl,H2<\/sub>Oin diamorphine hydrochloride BPCRS.<\/p>\n The impurities limited by the requirements of this monograph those listed under Diamorphine Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Diamorphine Tablets General Notices Action and use\u00a0 Opioid receptor agonist analgesic. DEFINITION Diamorphine Tablets contain Diamorphine Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of diamorphine hydrochloride, C21H23NO5,HCl,H2O\u00a0 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of…<\/p>\n","protected":false},"author":5,"featured_media":14832,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-14831","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\/14831","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=14831"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14831\/revisions"}],"predecessor-version":[{"id":14836,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14831\/revisions\/14836"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14832"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14831"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14831"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
TEST CONDITIONS<\/h4>\n
PROCEDURE<\/h4>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
DETERMINATION OF CONTENT<\/h4>\n
LIMITS<\/h4>\n
Related substances<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
SYSTEM SUITABILITY<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
IMPURITIES<\/h2>\n