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- W2394363054 abstract "Objective: To study the influence of temperature on visible foreign bodies in gatifloxacin hydrochloride injection.Methods: The PH value of gatifloxacin hydrochloride injection was adjusted with 0.1 mol/L of hydrochloric acid,the solubility and stability of gatifloxacin hydrochloride in water were observed under different temperatures.Results: On the condition of the temperature above 20 ℃ and national quality standards of PH value(3.5～5.5),the visible foreign bodies in solution(A)of gatifloxacin hydrochloride injection met the criteria.On the condition of the temperature10～20 ℃ and PH value 4.6～5.5,there was crystallization in the solution;in the solution(B)with PH value 3.5～4.6,there was no crystallization,which met the criteria of visible foreign bodies in solution of gatifloxacin hydrochloride injection.On the condition of the temperature 0～1 ℃ and PH value 4.6～5.5,there was crystallization in the solution;in the solution(C)with PH value 3.5～4.0,there was no crystallization,which met the criteria of visible foreign bodies in solution of gatifloxacin hydrochloride injection.The solution A,B,C kept stable after 24 h;which still met the criteria according to relative determination of contents and foreign bodies after 15 min 121 ℃ sterilization.Conclusion: The temperature has markedly influence on visible foreign body in gatifloxacin hydrochloride injection." @default.
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- W2394363054 date "2008-01-01" @default.
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- W2394363054 title "Influence of temperature on visible foreign bodies in gatifloxacin hydrochloride injection" @default.
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