Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Aspirin Gastro-resistant Tablets<\/p>\n
General Notices<\/p>\n
Gastro-resistant Aspirin Tablets<\/p>\n
Action and use<\/p>\n
Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory and antiplatelet.<\/p>\n
Aspirin Gastro-resistant Tablets contain Aspirin. They are made gastro-resistant by enteric-coating or by other means. The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n
Content of aspirin, C9<\/sub>H8<\/sub>O4<\/sub><\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n Shake a quantity of the powdered tablets containing 0.5 g of Aspirin with 20 mL of absolute ethanol, filter (Whatman GF\/C is suitable), evaporate the filtrate and dry the residue at 60\u00b0 for 1 hour. The infrared absorption spectrum of the residue, is concordant with the reference spectrum of aspirin (RS 483).<\/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 TEST CONDITIONS<\/p>\n First stage<\/p>\n (a)\u2003Use Apparatus 1, rotating the basket at 100 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 PROCEDURE<\/p>\n (1)\u2003After 2 hours, withdraw a sample of the medium, filter and measure the absorbance of the filtrate, Appendix II B, at 276 nm using 0.1M hydrochloric acid in the reference cell.<\/p>\n (2)\u2003Measure the absorbance of a suitable solution of aspirin BPCRS in 0.1M hydrochloric acid.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the total content of aspirin, C9<\/sub>H8<\/sub>O4<\/sub>, in the medium using the declared content of C9<\/sub>H8<\/sub>O4<\/sub> in aspirin BPCRS. The amount of aspirin released is not more than 5% of the stated amount.<\/p>\n Final stage<\/p>\n (a)\u2003Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n (b)\u2003Replace the 0.1M hydrochloric acid in the vessel with 900 mL of mixed phosphate buffer pH 6.8, previously held at 36.5\u00b0 to 37.5\u00b0.<\/p>\n PROCEDURE<\/p>\n (1)\u2003After 45 minutes, withdraw a sample of the medium and filter. Immediately measure the absorbance of the filtrate, Appendix II B, diluted with the dissolution medium, if necessary, at 265 nm using dissolution medium in the reference cell. (2)\u2003Measure the absorbance of a suitable solution of aspirin BPCRS in the dissolution medium.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the total content of aspirin, C9<\/sub>H8<\/sub>O4<\/sub>, in the medium using the declared content of C9<\/sub>H8<\/sub>O4<\/sub> in aspirin BPCRS.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.<\/p>\n (1)\u2003Mix with the aid of ultrasound for 15 minutes, a quantity of the powdered tablets containing 0.10 g of Aspirin with 40 mL of acetonitrile, allow to cool, dilute to 100 mL with water and filter through a 0.45-\u00b5m PTFE filter. (2)\u2003Dilute 1 volume of solution (1) to 50 volumes and further dilute 1 volume of the resulting solution to 10 volumes with the mobile phase.<\/p>\n (3)\u20030.001% w\/v of salicylic acid (impurity C) in the mobile phase.<\/p>\n (4)\u20030.1% w\/v of aspirin impurity standard BPCRS in the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a)\u2003Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) (Kromasil C18 is suitable).<\/p>\n (b)\u2003Use isocratic elution and the mobile phase described below.<\/p>\n (c)\u2003Use a flow rate of 1.0 mL per minute.<\/p>\n (d)\u2003Use an ambient column temperature.<\/p>\n (e)\u2003Use a detection wavelength of 237 nm.<\/p>\n (f)\u2003Inject 20 \u00b5L of each solution.<\/p>\n (g)\u2003Allow the chromatography to proceed for 1.2 times the retention time of impurity F.<\/p>\n MOBILE PHASE<\/p>\n 2 volumes of orthophosphoric acid, 400 volumes of acetonitrile and 600 volumes of water.<\/p>\n When the chromatograms are recorded under the prescribed conditions, the retentions relative to aspirin (retention time about 5 minutes) are: impurity A, about 0.6; impurity B, about 0.7; impurity C, about 1.4; impurity D, about 2.9; impurity E, about 4.3 and impurity F, about 8.0.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to aspirin and impurity C is at least 6.0.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to impurities A and B is at least 2.5.<\/p>\n LIMITS<\/p>\n Use the chromatogram supplied with aspirin impurity standard BPCRS and the chromatogram obtained with solution (4) to identify the peaks due to due to impurities A, B, C and F. Multiply the area of any peak corresponding to impurity B by a correction factor of 0.7.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity C is not greater than three times the area of the principal peak in the chromatogram obtained with solution (3) (3%);<\/p>\n the area of any peak corresponding to impurities A, B, D, E or F is not greater than 0.15 times the area of the principal peak in the chromatogram obtained with solution (3) (0.15% of each);<\/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 (2) (0.10%);<\/p>\n the sum of the areas of any other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (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 (2) (0.05%).<\/p>\n ASSAY<\/p>\n Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Mix with the aid of ultrasound for 15 minutes, a quantity of the powdered tablets containing 60 mg of Aspirin with 40 mL of acetonitrile, allow to cool, dilute to 100 mL with water and filter through a 0.45-\u00b5m PTFE filter. (2)\u20030.06% w\/v of aspirin BPCRS in the mobile phase.<\/p>\n (3)\u20030.1% w\/v of aspirin impurity standard BPCRS in the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n The chromatographic procedure described under Related substances may be used.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to aspirin and impurity C is at least 6.0.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C9<\/sub>H8<\/sub>O4<\/sub>\u00a0in the tablets from the chromatograms obtained using the declared content of C9<\/sub>H8<\/sub>O4<\/sub> in aspirin BPCRS.<\/p>\n Aspirin Gastro-resistant Tablets should be protected from moisture.<\/p>\n The label states that the tablets contain Aspirin, unless this word appears in the name of the tablets (this requirement does not apply in countries where exclusive proprietary rights in the name Aspirin are claimed).<\/p>\n The impurities limited by the requirements of this monograph include those listed under Aspirin.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Aspirin Gastro-resistant Tablets General Notices Gastro-resistant Aspirin Tablets Action and use Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory and antiplatelet. DEFINITION Aspirin Gastro-resistant Tablets contain Aspirin. They are made gastro-resistant by enteric-coating or by other means. The tablets comply with the requirements stated under Tablets and with the…<\/p>\n","protected":false},"author":5,"featured_media":4059,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-4058","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\/4058","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=4058"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4058\/revisions"}],"predecessor-version":[{"id":7277,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4058\/revisions\/7277"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4059"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4058"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4058"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4058"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
Related substances<\/h3>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n
IMPURITIES<\/h2>\n