Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Smooth muscle relaxant; antispasmodic.<\/p>\n Alverine Capsules contain Alverine Citrate.<\/p>\n The capsules comply with the requirements stated under Capsules and with the following requirements.<\/p>\n Content of alverine citrate, C20<\/sub>H27<\/sub>N,C6<\/sub>H8<\/sub>O7<\/sub><\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n Shake a quantity of the contents of the capsules containing 0.12 g of Alverine Citrate with 5 mL of methanol for 5 minutes, filter through a 0.45-\u03bcm PTFE filter, evaporate the filtrate to dryness under a stream of nitrogen using a warm water bath and dry the residue for 1 hour at 50\u00b0 under vacuum. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of alverine citrate (RS 409).<\/p>\n Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n (a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n (b) Use 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) After 45 minutes withdraw a 20-mL sample of the medium and filter through a 0.45-\u03bcm filter, discarding the first 10 mL of the filtrate. Dilute, if necessary, with 0.1M hydrochloric acid to produce a solution expected to contain about 0.006% w\/v of Alverine Citrate.<\/p>\n (2) 0.006% w\/v of alverine citrate BPCRS in 0.1M hydrochloric acid.<\/p>\n The chromatographic conditions described under Related substances may be used.<\/p>\n Calculate the total content of alverine citrate, C20<\/sub>H27<\/sub>N,C6<\/sub>H8<\/sub>O7<\/sub>, in the medium from the chromatograms obtained and using the declared content of C20<\/sub>H27<\/sub>N,C6<\/sub>H8<\/sub>O7<\/sub> in alverine citrate BPCRS.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Add 80 mL of methanol to a quantity of the mixed contents of the capsules containing 0.6 g of Alverine Citrate. Mix with the aid of ultrasound for 1 hour, allow to cool to room temperature, add sufficient methanol to produce 100 mL, mix and filter (Whatman GF\/C is suitable).<\/p>\n (2) Dilute 1 volume of solution (1) to 100 volumes with methanol and dilute 1 volume of the resulting solution to 5 volumes with methanol.<\/p>\n (3) alverine citrate impurity standard solution BPCRS.<\/p>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil BDS C18 is suitable).<\/p>\n (b) Use isocratic 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 20 \u03bcL of each solution.<\/p>\n (g) Allow the chromatography to proceed for 4 times the retention time of alverine.<\/p>\n 0.01M sodium dodecyl sulfate in a mixture of 45 volumes of water and 55 volumes of acetonitrile, adjusting the pH of the mixture to 3.0 with orthophosphoric acid.<\/p>\n The test is not valid unless the chromatogram obtained with solution (3) closely resembles the reference chromatogram supplied with alverine citrate impurity standard solution BPCRS.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to alverine citrate impurity A, is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n the area of any peak corresponding to alverine citrate impurity C is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n the area of any peak corresponding to alverine citrate impurity D is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n the sum of the areas of all secondary peaks is not greater than 7 times the area of the principal peak in the chromatogram obtained with solution (2) (1.4%).<\/p>\n Disregard any peak with an area less than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n Weigh and powder the contents of 20 capsules. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) To a quantity of the mixed contents of the capsules containing 0.6 g Alverine Citrate add 100 mL of methanol, mix with the aid of ultrasound for 1 hour and add sufficient methanol to produce 500 mL. Stir vigorously for 10 minutes and filter (Cellulose nitrate filter 0.45 \u03bcm is suitable). Dilute 1 volume of the filtrate to 2 volumes with water.<\/p>\n (2) Dilute 1 volume of a 0.6% w\/v solution of alverine citrate BPCRS in methanol to 10 volumes with water.<\/p>\n (3) alverine citrate impurity standard solution BPCRS.<\/p>\n The chromatographic conditions described under Related substances may be used.<\/p>\n The test is not valid unless the chromatogram obtained closely resembles the reference chromatogram supplied with alverine citrate impurity standard solution BPCRS.<\/p>\n Calculate the content of C20<\/sub>H27<\/sub>N,C6<\/sub>H8<\/sub>O7<\/sub> in the capsules using the declared content of C20<\/sub>H27<\/sub>N,C6<\/sub>H8<\/sub>O7<\/sub> in alverine citrate BPCRS.<\/p>\n Alverine Capsules should be stored in a dry place and not above 25 .<\/p>\n The impurities limited by the requirements of this monograph include impurities A, C and D listed under Alverine Citrate.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Smooth muscle relaxant; antispasmodic. DEFINITION Alverine Capsules contain Alverine Citrate. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of alverine citrate, C20H27N,C6H8O7 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of the contents of the…<\/p>\n","protected":false},"author":5,"featured_media":3027,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-3022","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\/3022","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=3022"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/3022\/revisions"}],"predecessor-version":[{"id":5100,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/3022\/revisions\/5100"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/3027"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=3022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=3022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=3022"}],"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
DETERMINATION OF CONTENT<\/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
SYSTEM SUITABILITY<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n