地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.991694294169206816977841699326169286916952680.19
210.041706897170426217055800.11
单位质量响应值RSD%判断
169696.50169878.490.08数据可信
供试品溶液-2025020421批-含0.5%吐温20的pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11563311-156331191.98390.553.1891.9890.553.18
21487759-148775987.53787.54
31538289-153828990.51090.51
41616859-161685995.13395.13
51487570-148757087.52687.53
61540059-154005990.61490.61
10min11594493-159449393.81795.651.8794.8496.661.87
21623399-162339995.51896.49
31650246-165024697.09898.10
41664821-166482197.95599.01
51587882-158788293.42894.40
61633462-163346296.11097.12
15min11596988-159698893.96495.552.0896.0397.622.07
21608049-160804994.61596.65
31653279-165327997.27699.36
41644864-164486496.78198.93
51579183-157918392.91694.93
61661589-166158997.76599.84
20min11571327-157132792.45495.742.9295.5698.872.88
21604424-160442494.40297.49
31655233-165523397.391100.56
41692378-169237899.577102.80
51585003-158500393.25996.30
61654735-165473597.362100.52
30min11561140-156114091.85594.062.3295.9998.252.31
21581413-158141393.04897.18
31644705-164470596.772101.02
41619160-161916095.26999.60
51556800-155680091.59995.68
61628218-162821895.802100.04
极限11595089-159508993.85293.951.9199.0199.191.91
21551020-155102091.25996.43
31620410-162041095.342100.66
41630185-163018595.917101.30
51571707-157170792.47797.57
61611991-161199194.847100.15
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