Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/p>\n
Sulfydryl donor; antidote to paracetamol poisoning; mucolytic.<\/p>\n
Acetylcysteine Injection is a sterile solution in Water for Injections of acetylcysteine sodium, prepared by the interaction of
\nAcetylcysteine with Sodium Hydroxide.<\/p>\n
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n
Content of acetylcysteine, C5<\/sub>H9<\/sub>NO3<\/sub>S<\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n To a volume containing the equivalent of 0.8 g of Acetylcysteine add 3M hydrochloric acid until the pH of the solution is 2.0. Acidity or alkalinity<\/strong><\/p>\n pH, 6.5 to 7.5, Appendix V L.<\/p>\n Related substances<\/strong><\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions. With the exception of (1)\u2003Dilute the injection with the mobile phase to produce a solution containing the equivalent of 0.2% w\/v of (a)\u2003Use a stainless steel column (25 cm \u00d7 5 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) 10 volumes of methanol and 90 volumes of a 0.5% w\/v solution of ammonium sulfate containing 0.02M sodium When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to The test is not valid unless, in the chromatogram obtained with solution (2), the peak-to-valley ratio is at least 2.5, where In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to N,N\u2032-diacetylL-cystine (impurity C) is not greater than the area of the peak due to the area of any peak corresponding to L-cysteine (impurity B) is not greater than twice the area of the corresponding peak the area of any peak corresponding to L-cystine (impurity A) is not greater than the area of the corresponding peak in the the sum of the areas of any other secondary peaks is not greater than the area of the peak due to acetylcysteine in the Disregard any peak with an area less than the area of the peak due to acetylcysteine in the chromatogram obtained with Hydrogen sulfide<\/strong><\/p>\n Place a quantity of the injection containing the equivalent of 0.4 g of Acetylcysteine in a round-bottomed, three-necked Prepare a 0.4% w\/v solution of sodium sulfide. Standardise this solution in the following manner. To 25 mL of 0.05M iodine Repeat the procedure carried out on the injection using 2 mL of the 20 ppm hydrogen sulfide solution in place of the Bacterial endotoxins<\/strong><\/p>\n Carry out the test for bacterial endotoxins, Appendix XIV C. If necessary, dilute the injection with water BET to give a Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Dilute the injection with the mobile phase to produce a solution containing the equivalent of 0.2% w\/v of The chromatographic conditions described under Related substances may be used.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 2.5, where Calculate the content of C5H9NO3S in the injection using the declared content of C5H9NO3S in acetylcysteine BPCRS.<\/p>\n Acetylcysteine Injection should be protected from light.<\/p>\n The strength is stated in terms of the equivalent amount of acetylcysteine in a suitable dose-volume.<\/p>\n The impurities limited by the requirements of this monograph include impurities A, B and C listed under Acetylcysteine.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Sulfydryl donor; antidote to paracetamol poisoning; mucolytic. DEFINITION Acetylcysteine Injection is a sterile solution in Water for Injections of acetylcysteine sodium, prepared by the interaction of Acetylcysteine with Sodium Hydroxide. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements….<\/p>\n","protected":false},"author":5,"featured_media":3194,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-3181","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\/3181","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=3181"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/3181\/revisions"}],"predecessor-version":[{"id":5950,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/3181\/revisions\/5950"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/3194"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=3181"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=3181"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=3181"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}IDENTIFICATION<\/h2>\n
\nAdd, while stirring continuously, two 200 -mg portions of finely powdered sodium chloride followed, if necessary, by further
\n25-mg portions of sodium chloride until a precipitate begins to appear. Allow to stand for 15 minutes, filter and dry the
\nresidue at 70\u00b0 at a pressure not exceeding 0.7 kPa for 2 hours. The infrared absorption spectrum of the residue, Appendix
\nII A, is concordant with the reference spectrum of acetylcysteine (RS 003). Examine as discs prepared using potassium
\nbromide.<\/p>\nTESTS<\/h2>\n
\nsolution (3), the solutions should be prepared immediately before use.<\/p>\n
\nAcetylcysteine.
\n(2)\u2003Dissolve 20 mg of L-cysteine (impurity B) and 20 mg of L-cystine (impurity A) in 10 mL of 1M hydrochloric acid, add
\n40 mg of acetylcysteine BPCRS and immediately dilute to 100 mL with the mobile phase. Dilute 1 volume of the resulting
\nsolution to 20 volumes with the mobile phase.
\n(3)\u20030.2% w\/v solution of acetylcysteine BPCRS in the mobile phase and store at room temperature for at least 2 hours
\nbefore use (generation of N,N\u2032-diacetylcystine).
\n(4)\u2003Dilute 1 volume of solution (2) to 10 volumes with mobile phase.<\/p>\nCHROMATOGRAPHIC CONDITIONS<\/h3>\n
\n(LiChrosorb RP18 is suitable).
\n(b)\u2003Use isocratic elution and the mobile phase described below.
\n(c)\u2003Use a flow rate of 1 mL per minute.
\n(d)\u2003Use an ambient column temperature.
\n(e)\u2003Use a detection wavelength of 205 nm.
\n(f)\u2003Inject 20 \u00b5L of each solution.
\n(g)\u2003Allow the chromatography to proceed for three times the retention time of acetylcysteine.<\/p>\nMOBILE PHASE<\/h3>\n
\npentanesulfonate. Adjust the pH of the mixture, if necessary, to pH 2.0 using 2M hydrochloric acid.<\/p>\n
\nacetylcysteine (retention time about 6 minutes) are: cystine, about 0.6; cysteine, about 0.7; N,N\u2032-diacetylcystine, about 2.2.<\/p>\nSYSTEM SUITABILITY<\/h3>\n
\nHp is the height above the baseline of the peak due to cysteine and Hv is the height above the baseline of the lowest point
\nof the curve separating this peak from the peak due to cystine.<\/p>\nLIMITS<\/h3>\n
\nacetylcysteine in the chromatogram obtained with solution (2) (1%);<\/p>\n
\nin the chromatogram obtained with solution (2) (1%);<\/p>\n
\nchromatogram obtained with solution (2) (0.5%);<\/p>\n
\nchromatogram obtained with solution (2) (1%).<\/p>\n
\nsolution (4) (0.1%).<\/p>\n
\nflask containing 40 mL of water. The flask is fitted with a gas inlet tube which reaches nearly to the bottom of the flask, a
\ndropping funnel containing hydrochloric acid and an outlet tube leading to a 100 mL graduated flask containing a mixture
\nof 1 mL of 5M sodium hydroxide and 50 mL of water. Pass through the flask a steady current of nitrogen and add 10 mL of
\nhydrochloric acid from the dropping funnel. Maintain the current of nitrogen for 30 minutes and then disconnect the
\nabsorption flask. Add to the flask 10 mL of a solution prepared by dissolving 0.1 g of N,N-dimethyl-p-phenylenediamine
\ndihydrochloride in a mixture of 45 mL of hydrochloric acid and 55 mL of water decolourised with activated charcoal before
\nuse, if necessary, and 5 mL of a 5% w\/v solution of iron(III) chloride hexahydrate in 1M hydrochloric acid and allow to stand
\nfor 20 minutes protected from light. Add sufficient water to produce 100 mL and measure the absorbance of the solution,
\nAppendix II B, at 665 nm using a 4 cm pathlength and using in the reference cell a solution prepared in the same manner
\nbut without the injection being examined.<\/p>\n
\nVS add 8 mL of hydrochloric acid and 25 mL of the sodium sulfide solution. Titrate with 0.1M sodium thiosulfate solution VS
\nusing starch solution, added towards the end point, as indicator. Repeat the operation without the sodium sulfide solution.
\nThe concentration of the sodium sulfide solution expressed in parts per million of hydrogen sulfide is the difference
\nbetween the titrations multiplied by 68.16. Prepare a solution containing the equivalent of 20 ppm of hydrogen sulfide by
\nappropriate dilution of the sodium sulfide solution with water.<\/p>\n
\ninjection being examined. The absorbance of the solution obtained from the injection is not greater than the absorbance of
\nthe solution obtained from the standard (100 ppm with reference to the content of acetylcysteine).<\/p>\n
\nsolution containing 10 mg per mL (solution A). The endotoxin limit concentration of solution A is not more than 0.3 IU
\nper mL.<\/p>\nASSAY<\/h2>\n
\nAcetylcysteine.
\n(2)\u20030.2% w\/v solution of acetylcysteine BPCRS in the mobile phase.
\n(3)\u2003Dissolve 20 mg of L-cystine (impurity A) and 20 mg of L-cysteine (impurity B) in 10 mL of 1M hydrochloric acid and
\ndilute to 100 mL with the mobile phase. Dilute 1 volume of the resulting solution to 20 volumes with the mobile phase.<\/p>\nCHROMATOGRAPHIC CONDITIONS<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
\nHp is the height above the baseline of the peak due to cysteine and Hv is the height above the baseline of the lowest point
\nof the curve separating this peak from the peak due to cystine.<\/p>\nDETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n
IMPURITIES<\/h2>\n