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jinfeng309金蟲 (正式寫手)
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[求助]
異溴粉霧劑,BP藥典標(biāo)準(zhǔn)中有關(guān)物質(zhì)的限度問題
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異溴粉霧劑,BP藥典標(biāo)準(zhǔn)中,有關(guān)物質(zhì)項(xiàng)下,同時(shí)收載了薄層和液相兩種方法,限度分別是: A. Carry out the method for thin-layer chromatography: LIMITS In the chromatogram obtained with solution (1): any spot corresponding to tropic acid is not more intense than the spot in the chromatogram obtained with solution (2)(0.5%); any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2)(0.5%). B. Carry out the method for liquid chromatography: LIMITS In the chromatogram obtained with solution (1): the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%); the sum of the areas of any such peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1%). Disregard any peak with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%). 請問,兩種方法需要同時(shí)滿足嗎?還是選擇其中的一種即可? |
干粉吸入制劑(DPI) |
金蟲 (正式寫手)
鐵蟲 (初入文壇)
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