(Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Lincosamide antibacterial.<\/p>\n Lincomycin Capsules contain Lincomycin Hydrochloride.<\/p>\n The capsules comply with the requirements stated under Capsules and with the following requirements.<\/p>\n Content of lincomycin, C18<\/sub>H34<\/sub>N2<\/sub>O6<\/sub>S<\/strong><\/p>\n 90.0 to 105.0% of the stated amount.<\/p>\n A. Extract a quantity of the capsule contents containing the equivalent of 0.2 g of lincomycin with 5 mL of a mixture of 4 volumes of chloroform and 1 volume of methanol. Filter and evaporate the filtrate. Dissolve the oily residue in 1 mL of water, add acetone until precipitation begins and then add a further 20 mL of acetone. Filter the precipitate, wash with two 10 mL quantities of acetone, dissolve the residue in a little of the chloroform\u2013methanol mixture, evaporate to dryness and dry at 60\u00b0 at a pressure not exceeding 2 kPa for 4 hours. The infrared absorption spectrum of the dried precipitate, Appendix II A, is concordant with the reference spectrum of lincomycin hydrochloride (RS 203).<\/p>\n B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to the trimethylsilyl derivative of lincomycin in the chromatogram obtained with solution (1).<\/p>\n Lincomycin B<\/strong><\/p>\n Examine solution (3) as described under the Assay but increase the sensitivity by 8 to 10 times while recording the peak derived from lincomycin B, which is eluted immediately before that derived from lincomycin.<\/p>\n LIMITS<\/p>\n The area of the peak derived from lincomycin B, when corrected for the sensitivity factor, is not more than 5% of the area of the peak derived from lincomycin.<\/p>\n Water<\/strong><\/p>\n The contents of the capsules contain not more than 7.0% w\/w of water, Appendix IX C. Use 0.3 g.<\/p>\n Carry out the method for gas chromatography, Appendix III B, using the following solutions.<\/p>\n (1) Add 10 mL of a 0.8% w\/w solution of dotriacontane (internal standard) in chloroform to 0.1 g of lincomycin hydrochloride BPCRS, dilute to 100 mL with a 2% w\/v solution of imidazole in chloroform and shake to dissolve. Place 4 mL of the resulting solution in a 15-mL ground-glass-stoppered centrifuge tube, add 1 mL of a mixture of 99 volumes of N,O-bis(trimethylsilyl)acetamide and 1 volume of trimethylchlorosilane, and swirl gently. Loosen the glass stopper and heat at 65\u00b0 for 30 minutes.<\/p>\n (2) Prepare in the same manner as solution (1) but omit the internal standard and use a quantity of the mixed contents of 20 capsules containing the equivalent of 90 mg of lincomycin in place of the lincomycin hydrochloride BPCRS.<\/p>\n (3) Prepare in the same manner as solution (1) but using a quantity of the mixed contents of 20 capsules containing the equivalent of 90 mg of lincomycin in place of the lincomycin hydrochloride BPCRS.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a glass column (1.5 m \u00d7 3 mm) packed with acid-washed silanised diatomaceous support impregnated with 3% w\/w of phenyl methyl silicone fluid (50% phenyl) (OV-17 is suitable) and maintained at 260\u00b0.<\/p>\n (b) Use helium as the carrier gas at a flow rate of about 45 mL per minute.<\/p>\n (c) Use an inlet temperature of 260\u00b0 to 290\u00b0.<\/p>\n (d) Use a flame ionisation detector at a temperature of 260\u00b0 to 290\u00b0.<\/p>\n (e) Inject 1 \u03bcL of each solution.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C18<\/sub>H34<\/sub>N2<\/sub>O6<\/sub>S in the capsules using the declared content of C18<\/sub>H34<\/sub>N2<\/sub>O6<\/sub>S in lincomycin hydrochloride BPCRS.<\/p>\n The quantity of active ingredient is stated in terms of the equivalent amount of lincomycin.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) Action and use Lincosamide antibacterial. DEFINITION Lincomycin Capsules contain Lincomycin Hydrochloride. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of lincomycin, C18H34N2O6S 90.0 to 105.0% of the stated amount. IDENTIFICATION A. Extract a quantity of the capsule contents containing the equivalent of 0.2 g…<\/p>\n","protected":false},"author":4,"featured_media":21078,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21076","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\/21076","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=21076"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21076\/revisions"}],"predecessor-version":[{"id":21081,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21076\/revisions\/21081"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21078"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21076"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21076"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21076"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
ASSAY<\/h2>\n
LABELLING<\/h2>\n