盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402078242087082077742078152079752080190.19
215.432082592086172084380.13
单位质量响应值RSD%判断
13507.7313508.620.01数据可信
供试品溶液-2024042721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191690-9169045.39048.694.8745.3948.694.87
297565-9756548.29948.30
3104018-10401851.49351.49
4101834-10183450.41250.41
594065-9406546.56646.57
6100992-10099249.99550.00
10min1198215-19821598.12597.921.1798.3898.191.17
2194717-19471796.39396.66
3200980-20098099.49399.78
4199703-19970398.86199.14
5196920-19692097.48397.74
6196313-19631397.18397.46
15min1202459-202459100.225100.071.81101.02100.891.80
2200752-20075299.380100.18
3208560-208560103.246104.08
4202906-202906100.447101.28
5197668-19766897.85498.65
6200574-20057499.292100.11
20min1201034-20103499.52099.981.98100.87101.351.97
2196308-19630897.18098.54
3207898-207898102.918104.33
4204819-204819101.394102.78
5200190-20019099.102100.45
6201501-20150199.751101.12
30min1197430-19743097.73696.912.3399.6498.842.31
2194610-19461096.34098.24
3202146-202146100.071102.05
4198829-19882998.428100.38
5190730-19073094.41996.31
6190861-19086194.48496.41
45min1191830-19183094.96495.720.6397.4198.180.63
2192924-19292495.50597.94
3194007-19400796.04198.58
4192582-19258295.33697.83
5193450-19345095.76698.18
6195313-19531396.68899.14
极限1192922-19292295.50496.541.6798.4899.541.65
2195077-19507796.57199.53
3198875-19887598.451101.52
4195903-19590396.980100.01
5189887-18988794.00296.95
6197480-19748097.761100.75
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402081582080082081902081782084922082050.09
215.432102802105322104060.09
单位质量响应值RSD%判断
13519.8113636.160.61数据可信
供试品溶液-2024042721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195085-9508546.83045.334.2546.8345.334.25
291652-9165245.13945.14
388969-8896943.81843.82
494328-9432846.45746.46
586066-8606642.38842.39
696121-9612147.34047.34
10min1203432-203432100.19195.592.71100.4595.842.71
2194844-19484495.96296.21
3187789-18778992.48792.73
4191851-19185194.48894.75
5191857-19185794.49094.73
6194771-19477195.92696.19
15min1202626-20262699.79499.181.84100.6199.961.82
2201966-20196699.469100.25
3199254-19925498.13498.89
4204917-204917100.923101.71
5204433-204433100.684101.44
6195063-19506396.06996.87
20min1203823-203823100.38499.111.34101.75100.441.33
2203122-203122100.039101.38
3200352-20035298.67499.98
4201824-20182499.399100.74
5201990-20199099.481100.80
6196321-19632196.68998.02
30min1200982-20098298.98596.991.68100.9198.871.67
2195792-19579296.42898.32
3194792-19479295.93697.79
4200609-20060998.801100.70
5196775-19677596.91398.79
6192614-19261494.86396.73
45min1198232-19823297.63096.862.10100.1199.282.08
2196788-19678896.91999.35
3193923-19392395.50897.89
4202681-20268199.821102.27
5197818-19781897.42699.84
6190554-19055493.84996.24
极限1195741-19574196.40396.911.5799.4299.871.54
2198137-19813797.583100.55
3195108-19510896.09299.01
4200506-20050698.750101.75
5199061-19906198.038100.99
6192048-19204894.58597.50
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402094322088972091492096132091102092400.14
215.432093932095372094650.05
单位质量响应值RSD%判断
13587.0113575.180.07数据可信
供试品溶液-0801101批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179152-7915238.97340.567.2138.9740.567.21
278522-7852238.66338.66
389615-8961544.12544.12
476598-7659837.71637.72
590151-9015144.38944.39
680245-8024539.51139.51
10min1184231-18423190.71291.442.9590.9391.672.96
2180176-18017688.71688.93
3190264-19026493.68393.93
4180541-18054188.89589.10
5194017-19401795.53195.78
6185031-18503191.10691.33
15min1198050-19805097.51697.521.8598.2498.251.86
2199052-19905298.01098.72
3198806-19880697.88998.65
4191357-19135794.22194.92
5202522-20252299.718100.50
6198535-19853597.75598.48
20min1195834-19583496.42597.711.5297.6998.991.53
2200130-20013098.54199.79
3202443-20244399.679100.99
4195249-19524996.13797.36
5200709-20070998.826100.16
6196345-19634596.67797.95
30min1196422-19642296.71597.001.4198.5198.821.43
2196695-19669596.84998.65
3198292-19829297.63699.50
4192655-19265594.86096.62
5201156-20115699.046100.93
6196802-19680296.90298.71
45min1191606-19160694.34494.131.5096.6896.481.50
2192722-19272294.89397.23
3193607-19360795.32997.73
4187412-18741292.27894.57
5193818-19381895.43397.86
6187847-18784792.49394.84
极限1191722-19172294.40194.141.5997.2697.021.59
2188896-18889693.00995.87
3193156-19315695.10798.04
4187323-18732392.23595.04
5195734-19573496.37699.34
6190376-19037693.73896.60
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.402089262087522088922091802092852090070.11
215.432113922119512116720.19
单位质量响应值RSD%判断
13571.8813718.210.76数据可信
供试品溶液-0801101批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170461-7046134.53238.549.7434.5338.549.75
288362-8836243.30543.31
370660-7066034.63034.63
475601-7560137.05137.05
580725-8072539.56239.56
686015-8601542.15542.16
10min1172765-17276584.67088.383.2184.8688.593.22
2185334-18533490.83091.07
3175859-17585986.18786.38
4176996-17699686.74486.95
5185850-18585091.08391.30
6185144-18514490.73790.97
15min1201002-20100298.50997.121.5099.1797.831.50
2201570-20157098.78799.53
3198095-19809597.08497.76
4194498-19449895.32196.01
5194942-19494295.53996.26
6198933-19893397.49598.23
20min1201418-20141898.71396.422.6299.9297.662.60
2202480-20248099.233100.53
3193587-19358794.87596.09
4192611-19261194.39795.61
5190401-19040193.31394.57
6199928-19992897.98399.26
30min1202357-20235799.17396.482.16100.9398.262.14
2201798-20179898.899100.74
3194234-19423495.19296.93
4193230-19323094.70096.44
5193005-19300594.59096.36
6196501-19650196.30398.13
45min1199116-19911697.58595.731.6699.8998.051.65
2199228-19922897.640100.03
3193372-19337294.77097.04
4193166-19316694.66996.94
5191582-19158293.89296.19
6195581-19558195.85298.21
极限1196934-19693496.51595.431.7899.3798.281.78
2199376-19937697.712100.65
3192722-19272294.45197.24
4191411-19141193.80896.60
5191049-19104993.63196.45
6196818-19681896.45899.35
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