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%
115.231723191727021723971722241724221724130.11
215.221717241717601717420.02
单位质量响应值RSD%判断
11320.6211283.970.23数据可信
供试品溶液-25022001-1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%
30min131178-3117816.12815.723.3416.1315.723.35
231426-3142616.25616.26
328930-2893014.96514.96
430659-3065915.85915.86
530821-3082115.94315.94
629364-2936415.18915.19
60min155232-5523228.57027.662.6728.6027.692.67
253189-5318927.51327.54
351304-5130426.53826.56
454197-5419728.03528.06
554412-5441228.14628.17
652556-5255627.18627.21
120min188028-8802845.53544.721.9045.6144.791.90
286449-8644944.71844.79
383485-8348543.18543.25
487732-8773245.38245.45
587025-8702545.01645.09
686018-8601844.49544.57
240min1128074-12807466.25065.871.7366.4066.021.74
2127224-12722465.81065.96
3123228-12322863.74363.88
4128439-12843966.43966.59
5127351-12735165.87666.02
6129701-12970167.09167.24
360min1155902-15590280.64578.611.7180.9178.871.71
2151673-15167378.45778.71
3148349-14834976.73876.98
4153764-15376479.53979.80
5151056-15105678.13878.40
6151118-15111878.17078.43
480min1173841-17384189.92488.751.2590.3289.141.26
2171482-17148288.70489.09
3168080-16808086.94487.32
4173844-17384489.92590.32
5171261-17126188.58988.98
6170979-17097988.44388.83
600min1183221-18322194.77693.541.2995.3294.081.29
2180673-18067393.45893.99
3176822-17682291.46691.99
4183094-18309494.71095.25
5180789-18078993.51894.05
6180391-18039193.31293.85
720min1188768-18876897.64596.621.1198.3597.311.11
2186686-18668696.56897.26
3183197-18319794.76495.44
4188794-18879497.65998.36
5187124-18712496.79597.49
6186146-18614696.28996.98
960min1194435-194435100.57799.891.29101.44100.741.29
2192956-19295699.812100.66
3188530-18853097.52298.35
4195403-195403101.077101.94
5194719-194719100.724101.58
6192604-19260499.630100.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1197446-197446102.134101.531.41103.17102.551.40
2195396-195396101.074102.09
3191256-19125698.93299.93
4198885-198885102.879103.91
5198179-198179102.513103.53
6196512-196512101.651102.67
1440min1198350-198350102.602102.211.36103.81103.401.35
2197575-197575102.201103.39
3192425-19242599.537100.70
4199819-199819103.362104.56
5199379-199379103.134104.33
6197992-197992102.417103.60
极限1198204-198204102.526102.041.33103.90103.391.33
2197526-197526102.176103.53
3192388-19238899.518100.84
4199439-199439103.165104.54
5199365-199365103.127104.49
6196604-196604101.699103.06
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%
115.231716841718381718141723881714731718390.20
215.221723941722201723070.08
单位质量响应值RSD%判断
11282.9311321.090.24数据可信
供试品溶液-25022001-2-1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%
30min127981-2798114.47414.634.7014.4714.634.70
230740-3074015.90115.90
327346-2734614.14614.15
428787-2878714.89114.89
527676-2767614.31714.32
627185-2718514.06314.06
60min149496-4949625.60425.962.9025.6325.982.90
252950-5295027.39127.42
349302-4930225.50325.53
450635-5063526.19326.22
549290-4929025.49725.52
649406-4940625.55725.58
120min180500-8050041.64241.891.8141.7141.951.82
283778-8377843.33843.41
380543-8054341.66441.73
481243-8124342.02642.09
579912-7991241.33841.40
679874-7987441.31841.38
240min1120247-12024762.20361.881.0462.3462.021.04
2121415-12141562.80762.95
3119728-11972861.93462.07
4119950-11995062.04962.19
5118078-11807861.08161.22
6118366-11836661.23061.36
360min1146201-14620175.62874.331.0675.8774.581.06
2144378-14437874.68574.93
3143651-14365174.30974.55
4143653-14365374.31074.55
5141998-14199873.45473.69
6142316-14231673.61973.86
480min1168359-16835987.09084.521.5287.4684.881.51
2162731-16273184.17984.55
3162590-16259084.10684.47
4162549-16254984.08584.45
5161565-16156583.57683.94
6162517-16251784.06884.43
600min1181930-18193094.11189.662.4594.6290.162.44
2171780-17178088.86089.37
3172071-17207189.01189.51
4171965-17196588.95689.46
5170866-17086688.38788.89
6171298-17129888.61189.11
720min1185441-18544195.92792.241.9996.5992.901.98
2177431-17743191.78392.45
3177218-17721891.67392.32
4176559-17655991.33291.99
5175968-17596891.02691.67
6177294-17729491.71292.36
960min1192000-19200099.32095.561.98100.1596.371.98
2184000-18400095.18196.00
3183672-18367295.01295.82
4182169-18216994.23495.04
5182413-18241394.36095.16
6184101-18410195.23496.03
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1194819-194819100.77896.902.00101.7797.871.99
2186316-18631696.37997.35
3186163-18616396.30097.26
4185034-18503495.71696.68
5185051-18505195.72596.68
6186554-18655496.50397.46
1440min1197018-197018101.91597.682.17103.0898.812.17
2187759-18775997.12698.26
3186737-18673796.59797.72
4186633-18663396.54397.67
5186328-18632896.38697.50
6188456-18845697.48698.61
极限1196864-196864101.83697.512.24103.1798.802.23
2187248-18724896.86298.16
3187245-18724596.86098.14
4185547-18554795.98297.27
5185917-18591796.17397.45
6188139-18813997.32298.60
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