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%
115.041757781754541751841755351746751753250.25
215.161753721753241753480.02
单位质量响应值RSD%判断
11657.2511566.490.56数据可信
供试品溶液-2025032321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%
30min129748-2974815.29115.272.2915.2915.282.29
229838-2983815.33815.34
329759-2975915.29715.30
428960-2896014.88614.89
530872-3087215.86915.87
629102-2910214.95914.96
60min153425-5342527.46227.370.4727.4927.400.48
253320-5332027.40827.43
353261-5326127.37827.40
453138-5313827.31527.34
553541-5354127.52227.55
652825-5282527.15427.18
120min184993-8499343.68943.831.3443.7643.901.34
284878-8487843.63043.70
384101-8410143.23143.30
484746-8474643.56243.63
585523-8552343.96244.03
687409-8740944.93145.00
240min1127559-12755965.57065.410.5665.7165.560.56
2127888-12788865.73965.88
3127343-12734365.45965.60
4126349-12634964.94865.09
5126419-12641964.98465.13
6127977-12797765.78465.93
360min1153561-15356178.93678.210.6779.1978.460.67
2152325-15232578.30078.55
3151713-15171377.98678.24
4151275-15127577.76078.01
5150989-15098977.61377.87
6153016-15301678.65578.91
480min1169774-16977487.27086.270.6787.6586.650.67
2167240-16724085.96786.35
3167474-16747486.08786.47
4167285-16728585.99086.37
5166690-16669085.68486.07
6168474-16847486.60186.99
600min1177512-17751291.24790.700.7691.7891.230.76
2176941-17694190.95491.48
3176685-17668590.82291.35
4175180-17518090.04890.57
5174506-17450689.70290.23
6177875-17787591.43491.96
720min1182370-18237093.74493.300.4994.4393.980.49
2181544-18154493.32094.00
3181606-18160693.35294.03
4181285-18128593.18793.86
5179938-17993892.49493.17
6182310-18231093.71394.40
960min1189263-18926397.28896.210.6998.1397.040.69
2187272-18727296.26497.10
3186409-18640995.82096.65
4186197-18619795.71296.54
5185854-18585495.53596.36
6187952-18795296.61497.45
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193714-19371499.57698.810.56100.5899.800.55
2192474-19247498.93899.93
3191738-19173898.56099.55
4191951-19195198.66999.66
5190607-19060797.97898.97
6192844-19284499.128100.13
1440min1194336-19433699.89599.320.54101.06100.480.54
2193464-19346499.447100.61
3192781-19278199.096100.25
4193270-19327099.347100.50
5191426-19142698.39999.55
6193977-19397799.711100.88
极限1194141-19414199.79599.180.72101.13100.510.72
2193411-19341199.420100.75
3191915-19191598.65199.97
4192628-19262899.017100.34
5190970-19097098.16599.48
6194632-194632100.047101.38
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%
115.041750771751211757601756521754021754020.18
215.161758991755241757120.16
单位质量响应值RSD%判断
11662.3711590.500.44数据可信
供试品溶液-2025032321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%
30min127560-2756014.14914.994.3614.1514.994.37
230030-3003015.41715.42
328855-2885514.81414.81
427932-2793214.34014.34
530338-3033815.57515.58
630496-3049615.65615.66
60min150323-5032325.83527.164.0125.8627.184.01
255535-5553528.51128.54
351884-5188426.63726.66
451062-5106226.21526.24
553759-5375927.59927.63
654826-5482628.14728.17
120min182073-8207342.13543.382.2242.2043.452.22
285811-8581144.05444.13
383821-8382143.03343.10
482770-8277042.49342.56
585863-8586344.08144.15
686638-8663844.47944.55
240min1127043-12704365.22265.561.4865.3665.701.48
2128846-12884666.14866.29
3126603-12660364.99665.14
4124872-12487264.10864.25
5128799-12879966.12466.27
6130060-13006066.77166.92
360min1151565-15156577.81178.421.2178.0678.671.22
2153247-15324778.67578.93
3152261-15226178.16978.42
4150030-15003077.02377.27
5154240-15424079.18579.44
6155101-15510179.62779.89
480min1167767-16776786.12986.621.8586.5087.001.84
2167379-16737985.93086.32
3167715-16771586.10386.48
4165142-16514284.78285.16
5170175-17017587.36687.75
6174161-17416189.41289.80
600min1176957-17695790.84791.201.2691.3791.721.26
2176761-17676190.74791.28
3176797-17679790.76591.29
4174725-17472589.70190.22
5179989-17998992.40492.94
6180590-18059092.71393.25
720min1182440-18244093.66294.071.2294.3394.751.23
2181899-18189993.38594.07
3182909-18290993.90394.58
4180503-18050392.66893.33
5185054-18505495.00495.69
6186649-18664995.82396.52
960min1188062-18806296.54996.911.3597.3797.741.36
2187102-18710296.05696.89
3188499-18849996.77397.60
4185530-18553095.24996.07
5190761-19076197.93498.78
6192592-19259298.87499.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1195007-195007100.114100.151.44101.10101.141.44
2193468-19346899.324100.32
3193552-19355299.367100.36
4191782-19178298.45899.44
5197189-197189101.234102.24
6199440-199440102.390103.41
1440min1194847-194847100.03299.841.18101.19101.001.18
2192525-19252598.840100.00
3193488-19348899.334100.49
4192001-19200198.57199.71
5195845-195845100.544101.72
6198101-198101101.702102.89
极限1195399-195399100.315100.071.15101.64101.411.15
2195010-195010100.116101.44
3193328-19332899.252100.58
4191788-19178898.46199.77
5195693-195693100.466101.81
6198362-198362101.836103.20
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