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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
115.061760671756461758281754221753771756680.17
215.101753301754001753650.03
单位质量响应值RSD%判断
11664.5411613.580.31数据可信
供试品溶液-1270307批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min131924-3192416.37216.452.9016.3716.452.89
233159-3315917.00517.00
332465-3246516.64916.65
431172-3117215.98615.99
530856-3085615.82415.82
632881-3288116.86216.86
60min153126-5312627.24427.322.0827.2727.352.09
254773-5477328.08928.12
353390-5339027.38027.41
452583-5258326.96626.99
551643-5164326.48426.51
654118-5411827.75327.78
120min184842-8484243.50943.701.7043.5843.781.71
287704-8770444.97745.05
385011-8501143.59643.67
484339-8433943.25143.32
583522-8352242.83242.90
685902-8590244.05344.13
240min1128361-12836165.82765.861.1565.9766.001.15
2130503-13050366.92667.08
3128432-12843265.86366.01
4128217-12821765.75365.90
5125957-12595764.59464.74
6129044-12904466.17766.33
360min1157517-15751780.77980.020.7581.0380.270.75
2156839-15683980.43180.69
3156126-15612680.06680.32
4156022-15602280.01280.27
5154122-15412279.03879.29
6155582-15558279.78780.04
480min1180440-18044092.53591.450.6892.9291.840.68
2178770-17877091.67892.07
3178127-17812791.34891.74
4178173-17817391.37291.76
5176963-17696390.75191.13
6177472-17747291.01391.40
600min1190644-19064497.76796.610.6398.3197.150.63
2188108-18810896.46797.02
3188327-18832796.57997.12
4188310-18831096.57197.11
5187665-18766596.24096.77
6187231-18723196.01796.56
720min1194850-19485099.92499.030.51100.6399.730.51
2192866-19286698.90799.62
3192084-19208498.50699.21
4192990-19299098.97199.67
5193407-19340799.18499.88
6192392-19239298.66499.37
960min1196530-196530100.78699.820.52101.66100.690.52
2194614-19461499.803100.68
3193825-19382599.399100.27
4194864-19486499.932100.80
5194064-19406499.521100.38
6193978-19397899.477100.34
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1197345-197345101.204100.440.47102.25101.480.47
2195907-195907100.466101.51
3195230-195230100.119101.15
4196401-196401100.720101.75
5195468-195468100.241101.27
6194783-19478399.890100.92
1440min1194420-19442099.70499.200.35100.91100.400.34
2193717-19371799.343100.55
3192760-19276098.853100.05
4193704-19370499.337100.54
5193366-19336699.163100.35
6192672-19267298.807100.01
极限1193838-19383899.40599.110.29100.78100.480.29
2193604-19360499.285100.66
3192486-19248698.712100.08
4193778-19377899.375100.74
5192863-19286398.905100.26
6193030-19303098.991100.36
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
115.061757621755871757021754011751721755250.14
215.101756781757061756920.02
单位质量响应值RSD%判断
11655.0511635.230.13数据可信
供试品溶液-1270307批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min133309-3330917.07316.772.0217.0716.772.03
232063-3206316.43416.43
333692-3369217.26917.27
432103-3210316.45516.45
532445-3244516.63016.63
632713-3271316.76716.77
60min155763-5576328.58227.981.9128.6128.001.92
254696-5469628.03528.06
355716-5571628.55828.59
453564-5356427.45527.48
553289-5328927.31427.34
654480-5448027.92427.95
120min188563-8856345.39444.311.9945.4744.381.99
285661-8566143.90643.98
388089-8808945.15145.23
485443-8544343.79443.87
584043-8404343.07743.15
686837-8683744.50944.58
240min1131757-13175767.53366.271.5167.6866.421.51
2128792-12879266.01366.16
3131444-13144467.37367.52
4128356-12835665.79065.94
5126658-12665864.92065.06
6128767-12876766.00166.15
360min1158952-15895281.47280.451.0881.7480.711.08
2156497-15649780.21480.47
3158968-15896881.48081.74
4156419-15641980.17480.43
5154687-15468779.28679.54
6156275-15627580.10080.36
480min1181386-18138692.97191.621.1593.3792.021.15
2179429-17942991.96892.36
3180497-18049792.51592.91
4176861-17686190.65191.04
5176220-17622090.32390.71
6178150-17815091.31291.70
600min1191350-19135098.07896.591.2298.6397.141.22
2189889-18988997.32997.87
3190025-19002597.39997.95
4186594-18659495.64096.18
5185523-18552395.09195.63
6187324-18732496.01496.56
720min1196652-196652100.79599.041.17101.5199.741.17
2194519-19451999.702100.41
3193520-19352099.19099.91
4191803-19180398.31099.01
5190107-19010797.44198.14
6192732-19273298.78699.49
960min1198953-198953101.975100.221.20102.86101.091.20
2197224-197224101.089101.96
3195852-195852100.385101.27
4193644-19364499.254100.12
5192608-19260898.72399.58
6194897-19489799.896100.76
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1200677-200677102.859100.851.34103.91101.891.34
2198622-198622101.805102.85
3197110-197110101.030102.08
4196003-196003100.463101.49
5193549-19354999.205100.23
6194605-19460599.746100.78
1440min1198625-198625101.80799.841.36103.03101.051.35
2197036-197036100.992102.20
3195026-19502699.962101.18
4193106-19310698.978100.17
5191688-19168898.25199.44
6193257-19325799.055100.26
极限1199273-199273102.13999.611.57103.54100.981.56
2196429-196429100.681102.06
3194041-19404199.457100.84
4192503-19250398.669100.03
5190919-19091997.85799.21
6192882-19288298.863100.23
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