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500
标示量(mg)30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%
115.351711711713351709631712851710311711570.10
215.331705221709241707230.17
单位质量响应值RSD%判断
11150.2911136.530.09数据可信
供试品溶液-24082901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%
30min123478-2347812.31811.734.3112.3211.734.31
222419-2241911.76211.76
321066-2106611.05211.05
423448-2344812.30212.30
521687-2168711.37811.38
622091-2209111.59011.59
60min143637-4363722.89422.423.6022.9122.443.60
242190-4219022.13522.15
344504-4450423.34923.37
443515-4351522.83022.85
540105-4010521.04121.06
642499-4249922.29722.32
120min170585-7058537.03236.312.1437.0936.362.14
269941-6994136.69536.75
368328-6832835.84835.91
470169-7016936.81436.87
566634-6663434.96035.01
669567-6956736.49836.55
240min1107380-10738056.33755.462.0656.4655.582.06
2107870-10787056.59456.71
3104005-10400554.56654.68
4107255-10725556.27156.39
5102457-10245753.75453.87
6105277-10527755.23455.35
360min1132514-13251469.52469.021.6069.7469.231.59
2133843-13384370.22170.43
3130128-13012868.27268.48
4133813-13381370.20570.42
5129223-12922367.79768.00
6129775-12977568.08768.30
480min1150273-15027378.84178.171.2279.1778.491.22
2151745-15174579.61379.94
3147421-14742177.34577.67
4149487-14948778.42978.76
5147771-14777177.52877.84
6147242-14724277.25177.57
600min1162506-16250685.25984.271.2785.7284.721.27
2163635-16363585.85186.31
3159232-15923283.54183.99
4160117-16011784.00684.47
5159911-15991183.89784.34
6158303-15830383.05483.51
720min1169807-16980789.08988.770.8889.6989.360.88
2171836-17183690.15490.76
3168201-16820188.24788.84
4168487-16848788.39789.00
5169082-16908288.70989.29
6167743-16774388.00788.60
960min1180116-18011694.49893.760.7195.2594.510.71
2180290-18029094.58995.34
3178188-17818893.48794.22
4178164-17816493.47494.22
5178525-17852593.66394.40
6177013-17701392.87093.61
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184972-18497297.04696.280.9897.9697.180.98
2186308-18630897.74798.66
3182004-18200495.48996.38
4183008-18300896.01596.92
5183099-18309996.06396.95
6181711-18171195.33596.23
1440min1186761-18676197.98497.290.9499.0698.360.94
2188315-18831598.80099.88
3184071-18407196.57397.63
4185025-18502597.07498.14
5184172-18417296.62697.67
6184308-18430896.69797.75
极限1186476-18647697.83597.090.9599.0798.310.95
2187540-18754098.39399.63
3183927-18392796.49797.71
4185050-18505097.08798.31
5184702-18470296.90498.11
6182661-18266195.83397.04
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500
标示量(mg)30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%
115.351701621705561704901707391707641705420.15
215.331712351710591711470.08
单位质量响应值RSD%判断
11110.2311164.190.35数据可信
供试品溶液-1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%
30min122041-2204111.57011.771.8511.5711.781.85
222645-2264511.88711.89
322278-2227811.69511.69
422490-2249011.80611.81
522012-2201211.55511.56
623107-2310712.13012.13
60min140607-4060721.31621.712.0221.3421.742.01
241443-4144321.75521.78
340439-4043921.22821.25
441952-4195222.02322.04
541115-4111521.58321.60
642632-4263222.38022.40
120min165780-6578034.53135.411.7134.5935.461.71
267243-6724335.29935.36
366964-6696435.15235.21
468636-6863636.03036.09
567179-6717935.26535.32
668896-6889636.16736.22
240min1100316-10031652.66053.651.4252.7753.771.42
2101302-10130253.17853.29
3101502-10150253.28353.40
4104363-10436354.78554.90
5102797-10279753.96354.08
6102974-10297454.05654.17
360min1123335-12333564.74466.391.5264.9466.601.53
2126096-12609666.19466.40
3125571-12557165.91866.12
4128797-12879767.61167.82
5127521-12752166.94267.15
6127539-12753966.95167.16
480min1139228-13922873.08774.751.4573.4075.061.44
2141945-14194574.51374.83
3141650-14165074.35974.67
4145453-14545376.35576.68
5143221-14322175.18375.50
6142857-14285774.99275.31
600min1150984-15098479.25880.821.1779.6981.261.18
2153931-15393180.80581.24
3153650-15365080.65881.09
4156609-15660982.21182.66
5154354-15435481.02881.47
6154228-15422880.96181.41
720min1158452-15845283.17984.831.3783.7485.401.37
2161322-16132284.68585.26
3160671-16067184.34484.91
4165152-16515286.69687.28
5162494-16249485.30185.88
6161480-16148084.76885.35
960min1168161-16816188.27589.631.1088.9890.351.09
2170728-17072889.62390.34
3170108-17010889.29890.01
4173892-17389291.28492.01
5170404-17040489.45390.17
6171210-17121089.87690.60
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1172429-17242990.51692.001.2791.3692.861.27
2174246-17424691.47092.33
3174308-17430891.50292.36
4178577-17857793.74394.62
5177146-17714692.99293.86
6174800-17480091.76192.63
1440min1174226-17422691.45992.420.9692.4693.440.96
2176542-17654292.67593.69
3175009-17500991.87092.88
4179021-17902193.97695.01
5176247-17624792.52093.54
6175320-17532092.03493.06
极限1172965-17296590.79792.551.3891.9593.721.38
2176317-17631792.55793.73
3175323-17532392.03593.20
4180130-18013094.55995.75
5177690-17769093.27894.45
6175396-17539692.07393.25
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