Zidovudine Concentrate for Intravenous Infusion<\/p>\n
Action and use<\/strong><\/p>\n Nucleoside reverse transcriptase inhibitor; antiviral (HIV).<\/p>\n Zidovudine Infusion is a sterile solution containing Zidovudine. It is prepared by diluting Zidovudine Concentrate for Infusion in a suitable diluent in accordance with the manufacturer\u2019s instructions.<\/p>\n The infusion complies with the requirements stated under Parenteral Preparations.<\/p>\n Zidovudine Infusion should be used immediately after preparation but, in any case, within the period recommended by the manufacturer when prepared and stored strictly in accordance with the manufacturer\u2019s instructions.<\/p>\n ZIDOVUDINE CONCENTRATE FOR INFUSION<\/p>\n Zidovudine Concentrate for Infusion is a sterile solution consisting of Zidovudine with or without excipients. It is supplied in a sealed container.<\/p>\n The contents of the sealed container comply with the requirements for Concentrates for Injections or Infusions stated under Parenteral Preparations and with the following requirements.<\/p>\n Content of zidovudine, C10<\/sub>H13<\/sub>N5<\/sub>O4\u00a0<\/sub><\/strong><\/p>\n 95.0 to 105.0% of the stated amount.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions protected from light.<\/p>\n (1) Dilute a volume of the contents of the sealed container in sufficient methanol (50%) to produce a solution containing 0.1% w\/v of Zidovudine.<\/p>\n (2) 0.1% w\/v of zidovudine BPCRS in methanol (50%).<\/p>\n (a) Use precoated silica gel F254 plates (Merck silica gel 60 F254 plates are suitable).<\/p>\n (b) Use the mobile phase described below.<\/p>\n (c) Apply 10 \u03bcL of each solution.<\/p>\n (d) Develop the plate to 12 cm.<\/p>\n (e) After removal of the plate, dry it in air and immediately examine under ultraviolet light (254 nm).<\/p>\n 3 volumes of glacial acetic acid, 10 volumes of methanol and 90 volumes of dichloromethane.<\/p>\n The chromatogram obtained with solution (1) shows a principal spot corresponding in position, colour and size to the principal spot in the chromatograms obtained with solution (2).<\/p>\n B. In the Assay, the chromatogram obtained with solution (1) shows a principal peak with the same retention time as the principal peak due to zidovudine in the chromatogram obtained with solution (2).<\/p>\n pH of a solution containing 0.01% w\/v of Zidovudine, 3.5 to 7.0, Appendix V L.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions in mobile phase protected from light.<\/p>\n (1) Dilute a volume of the contents of the sealed container to produce a solution containing 0.1% w\/v of Zidovudine.<\/p>\n (2) Dilute 1 volume of solution (1) to 500 volumes.<\/p>\n (3) 0.01% w\/v of zidovudine impurity standard BPCRS.<\/p>\n (4) 0.003% w\/v of thymine.<\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Spherisorb ODS2 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.2 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 265 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n 20 volumes of methanol and 80 volumes of water.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3): the chromatogram closely resembles the reference chromatogram supplied with zidovudine impurity standard BPCRS; the resolution between the peaks due to zidovudine and zidovudine impurity B is at least 1.5.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to Impurity C (thymine) is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (3.0%);<\/p>\n the area of any peak with a relative retention time of 2.8 (Impurity G) is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (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 area of any peak corresponding to Impurity G and any other secondary peaks is not greater than 5 times<\/p>\n the area of the principal peak in the chromatogram obtained solution (2) (1.0%).<\/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 Carry out the method for liquid chromatography, Appendix III D, using the following solutions in mobile phase protected from light.<\/p>\n (1) Dilute a volume of the contents of the sealed container to produce a solution containing 0.02% w\/v of Zidovudine.<\/p>\n (2) 0.02% w\/v of zidovudine BPCRS.<\/p>\n (3) 0.01% w\/v of zidovudine impurity standard BPCRS.<\/p>\n 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 resolution between the peaks due to zidovudine and zidovudine impurity B is at least 1.5.<\/p>\n Calculate the content of C10<\/sub>H13<\/sub>N5<\/sub>O4<\/sub> in the infusion from the chromatograms obtained using the declared content of C10<\/sub>H13<\/sub>N5<\/sub>O4<\/sub> in zidovudine BPCRS.<\/p>\n The impurities limited by the requirements of this monograph include impurities B, C, E and G listed under Zidovudine.<\/p>\n","protected":false},"excerpt":{"rendered":" Zidovudine Concentrate for Intravenous Infusion Action and use Nucleoside reverse transcriptase inhibitor; antiviral (HIV). DEFINITION Zidovudine Infusion is a sterile solution containing Zidovudine. It is prepared by diluting Zidovudine Concentrate for Infusion in a suitable diluent in accordance with the manufacturer\u2019s instructions. The infusion complies with the requirements stated under Parenteral Preparations. STORAGE Zidovudine Infusion…<\/p>\n","protected":false},"author":4,"featured_media":22047,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22040","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\/22040","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=22040"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22040\/revisions"}],"predecessor-version":[{"id":22049,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22040\/revisions\/22049"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22047"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
STORAGE<\/h2>\n
DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
Acidity or alkalinity<\/h3>\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<\/h4>\n
SYSTEM SUITABILITY<\/h4>\n
DETERMINATION OF CONTENT<\/h4>\n
IMPURITIES<\/h2>\n