乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.201716911718021714001719681714051716530.15
215.311718161718211718180.01
单位质量响应值RSD%判断
11292.9611222.600.45数据可信
供试品溶液-25022501批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min128207-2820714.64915.293.8414.6515.293.84
229588-2958815.36615.37
331098-3109816.15016.15
428685-2868514.89714.90
528656-2865614.88214.88
630390-3039015.78215.78
60min151210-5121026.59526.782.3926.6226.812.39
251825-5182526.91426.94
349798-4979825.86125.89
453401-5340127.73327.76
550930-5093026.44926.47
652243-5224327.13127.16
120min182625-8262542.90942.891.5942.9842.961.59
283492-8349243.36043.43
380337-8033741.72141.79
483029-8302943.11943.19
581974-8197442.57142.64
684047-8404743.64843.72
240min1122326-12232663.52763.621.1963.6763.761.20
2124359-12435964.58364.73
3120492-12049262.57562.71
4122668-12266863.70563.85
5121368-12136863.03063.17
6123832-12383264.30964.45
360min1147803-14780376.75876.710.5777.0076.960.57
2148274-14827477.00377.25
3146867-14686776.27276.52
4147493-14749376.59776.85
5146810-14681076.24276.49
6148981-14898177.37077.62
480min1165577-16557785.98884.910.8486.3685.280.84
2163043-16304384.67285.05
3162670-16267084.47984.85
4163119-16311984.71285.09
5161888-16188884.07384.44
6164698-16469885.53285.91
600min1172765-17276589.72189.780.8190.2490.300.81
2172722-17272289.69990.22
3172495-17249589.58190.09
4172707-17270789.69190.21
5171169-17116988.89289.40
6175421-17542191.10191.62
720min1177620-17762092.24392.640.7892.9193.300.78
2178962-17896292.94093.61
3178693-17869392.80093.46
4178678-17867892.79293.46
5176138-17613891.47392.13
6180209-18020993.58794.26
960min1183289-18328995.18795.770.8996.0196.590.89
2184385-18438595.75696.58
3184273-18427395.69896.51
4184825-18482595.98496.81
5182442-18244294.74795.56
6187243-18724397.24098.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186320-18632096.76197.350.8897.7498.330.88
2187146-18714697.19098.17
3186837-18683797.02998.00
4189423-18942398.37299.35
5185523-18552396.34797.32
6189465-18946598.39499.39
1440min1187380-18738097.31197.710.8398.4598.860.82
2188478-18847897.88299.03
3188372-18837297.82698.96
4187950-18795097.60798.75
5186021-18602196.60697.74
6190719-19071999.045100.20
极限1186681-18668196.94897.560.8098.2598.860.80
2187819-18781997.53998.85
3187889-18788997.57698.88
4188346-18834697.81399.12
5186028-18602896.60997.90
6190362-19036298.860100.18
乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.201716711713001712361714991709281713270.17
215.311713611709451711530.18
单位质量响应值RSD%判断
11271.5111179.160.59数据可信
供试品溶液-25022501-1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min127548-2754814.34815.267.2614.3515.267.26
227135-2713514.13314.13
330694-3069415.98615.99
430974-3097416.13216.13
527546-2754614.34714.35
631948-3194816.63916.64
60min149841-4984125.95926.451.6825.9826.481.69
249955-4995526.01826.04
351481-5148126.81326.84
450936-5093626.52926.56
550532-5053226.31926.34
651993-5199327.08027.11
120min183188-8318843.32743.751.1343.3943.821.13
282868-8286843.16043.23
385425-8542544.49244.56
484280-8428043.89643.97
583733-8373343.61143.68
684562-8456244.04244.12
240min1126080-12608065.66665.930.6665.8166.070.66
2125746-12574665.49265.63
3128060-12806066.69866.84
4126103-12610365.67865.82
5126674-12667465.97666.12
6126834-12683466.05966.21
360min1152892-15289279.63179.800.9879.8880.050.97
2153909-15390980.16180.41
3155333-15533380.90281.16
4151181-15118178.74078.99
5153934-15393480.17480.42
6152061-15206179.19879.45
480min1169416-16941688.23787.941.1088.6288.331.10
2167062-16706287.01187.39
3171795-17179589.47689.87
4166674-16667486.80987.19
5169099-16909988.07288.46
6169046-16904688.04488.43
600min1178761-17876193.10492.821.1593.6393.351.15
2175575-17557591.44591.97
3181286-18128694.41994.96
4176403-17640391.87692.41
5179100-17910093.28193.81
6178114-17811492.76793.30
720min1184373-18437396.02795.830.9696.7196.520.96
2181484-18148494.52295.20
3186344-18634497.05497.75
4182552-18255295.07995.76
5185223-18522396.47097.16
6183986-18398695.82696.52
960min1189151-18915198.51698.860.9899.3699.710.98
2187403-18740397.60598.44
3192536-192536100.279101.14
4188834-18883498.35199.19
5191347-19134799.659100.51
6189646-18964698.77399.62
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190978-19097899.46799.701.02100.48100.721.02
2188754-18875498.30999.31
3193478-193478100.769101.80
4190087-19008799.003100.01
5193811-193811100.943101.96
6191490-19149099.734100.75
1440min1190630-19063099.28699.961.14100.46101.141.13
2188762-18876298.31399.48
3194396-194396101.247102.44
4191141-19114199.552100.72
5194138-194138101.113102.29
6192527-192527100.274101.45
极限1190425-19042599.179100.261.47100.52101.601.46
2189053-18905398.46599.79
3193557-193557100.810102.17
4191094-19109499.528100.86
5194177-194177101.133102.48
6196704-196704102.449103.80
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