Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Disease-modifying antirheumatic drug; chelating agent; treatment of Wilson\u2019s disease; heavy metal poisoning; cystinuria.<\/p>\n Penicillamine Tablets contain Penicillamine. They are coated.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n Content of penicillamine, C5<\/sub>H11<\/sub>NO2<\/sub>S<\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. Shake a quantity of the powdered tablets containing 20 mg of Penicillamine with 4 mL of water and filter. Add to the filtrate 2 mL of phosphotungstic acid solution and allow to stand for a few minutes. A deep blue colour is produced.<\/p>\n B. Dissolve a quantity of the powdered tablets containing 10 mg of Penicillamine in 5 mL of water and add 0.3 mL of 5M Not more than 10 ppm, calculated with reference to the content of penicillamine, when determined by the following method. Disperse a quantity of the powdered tablets containing 1 g of Penicillamine in 10 mL of water in a stoppered flask, add 0.2 mL of 9M perchloric acid and swirl to dissolve. Add 1 mL of ammonium pyrrolidinedithiocarbamate solution, mix, add 2 mL of 4-methylpentan-2-one, shake well for 1 minute and add sufficient water to produce 25 mL. Determine by atomic absorption spectrophotometry, Appendix II D, introducing the methylpentanone layer into the flame, measuring at 254 nm and using 4-methylpentan-2-one in place of water. Use mercury standard solution (10 ppm Hg) for the standard solutions, adjusted to contain the same concentrations of 9M perchloric acid, ammonium pyrrolidinedithiocarbamate solution and 4-methylpentan-2-one as the solution being examined.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Shake a quantity of the powdered tablets containing 40 mg of Penicillamine with 10 mL of the mobile phase, filter and use the filtrate.<\/p>\n (2) 0.004% w\/v of penicillamine disulfide EPCRS in the mobile phase.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octylsilyl silica gel for chromatography (5 \u00b5m) (Lichrospher 5 C8 is suitable).<\/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 20 \u00b5L of each solution.<\/p>\n 0.01% w\/v of disodium edetate and 0.2% w\/v of methane sulfonic acid.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to penicillamine disulfide is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n Weigh and powder 20 tablets. Dissolve a quantity of the powder containing 0.1 g of Penicillamine as completely as possible in 50 mL of water and filter. Add to the filtrate 5 mL of 1M sodium hydroxide and 0.2 mL of a 0.1% w\/v solution of dithizone in ethanol (96%) and titrate with 0.02M mercury(II) nitrate VS. Each mL of 0.02M mercury(II) nitrate VS is equivalent to 5.968 mg of C5<\/sub>H11<\/sub>NO2<\/sub>S.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Disease-modifying antirheumatic drug; chelating agent; treatment of Wilson\u2019s disease; heavy metal poisoning; cystinuria. DEFINITION Penicillamine Tablets contain Penicillamine. They are coated. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of penicillamine, C5H11NO2S 95.0 to 105.0% of the stated…<\/p>\n","protected":false},"author":5,"featured_media":19982,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19981","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\/19981","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=19981"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19981\/revisions"}],"predecessor-version":[{"id":19993,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19981\/revisions\/19993"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19982"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19981"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19981"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19981"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
\nsodium hydroxide and 20 mg of ninhydrin. An intense blue or violet-blue colour is produced immediately.<\/p>\nTESTS<\/h2>\n
Mercuric salts<\/h3>\n
Penicillamine disulfide<\/h3>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
MOBILE PHASE<\/h4>\n
LIMITS<\/h4>\n
ASSAY<\/h2>\n