利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214885194874084873364877964877134877540.10
215.184876644875964876300.01
单位质量响应值RSD%判断
32067.9832123.190.13数据可信
供试品溶液-24101601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%
5min191775-9177517.08816.2712.5117.0916.2812.51
296715-9671518.00818.01
379672-7967214.83414.83
478764-7876414.66514.67
575444-7544414.04714.05
6102037-10203718.99919.00
10min1172906-17290632.19430.484.1432.2230.514.15
2165093-16509330.73930.77
3158710-15871029.55129.58
4160826-16082629.94529.97
5155110-15511028.88128.90
6169694-16969431.59631.63
15min1206792-20679238.50336.972.6338.5937.052.63
2199898-19989837.22037.30
3195120-19512036.33036.40
4196954-19695436.67236.75
5191755-19175535.70435.78
6200859-20085937.39937.48
20min1228983-22898342.63541.152.0342.7841.292.03
2221592-22159241.25941.40
3218654-21865440.71240.85
4219307-21930740.83440.97
5215787-21578740.17840.31
6221604-22160441.26141.41
30min1254764-25476447.43646.301.2947.6546.511.30
2248860-24886046.33646.55
3247634-24763446.10846.31
4246897-24689745.97146.17
5245529-24552945.71645.91
6248378-24837846.24646.46
45min1276629-27662951.50750.800.7551.8051.080.76
2273098-27309850.84951.14
3272798-27279850.79351.07
4271616-27161650.57350.85
5270804-27080450.42250.70
6272083-27208350.66050.95
60min1290251-29025154.04353.500.6254.4353.870.63
2287433-28743353.51853.89
3288190-28819053.65954.02
4286374-28637453.32153.69
5285059-28505953.07653.43
6286775-28677553.39653.77
极限1300209-30020955.89755.410.6356.3755.870.64
2298965-29896555.66556.13
3297999-29799955.48655.94
4296311-29631155.17155.62
5295055-29505554.93755.38
6297092-29709255.31755.78
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214898154894334893794892364894574894640.05
215.184881114876674878890.07
单位质量响应值RSD%判断
32180.4132140.250.09数据可信
供试品溶液-24101601-1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%
5min184071-8407115.62216.988.1215.6216.988.12
297633-9763318.14218.14
397013-9701318.02718.03
499685-9968518.52318.52
585340-8534015.85815.86
684632-8463215.72615.73
10min1157238-15723829.21829.804.0929.2429.834.09
2163704-16370430.41930.45
3164339-16433930.53730.57
4166722-16672230.98031.01
5161603-16160330.02930.06
6148691-14869127.63027.66
15min1188485-18848535.02435.812.4735.1035.892.47
2194847-19484736.20636.29
3194946-19494636.22536.31
4197131-19713136.63136.71
5195633-19563336.35236.43
6185144-18514434.40334.48
20min1209809-20980938.98739.771.8039.1239.911.80
2215859-21585940.11140.25
3215952-21595240.12840.27
4217327-21732740.38440.53
5216804-21680440.28640.42
6208545-20854538.75238.88
30min1237892-23789244.20544.881.1944.4045.081.20
2242488-24248845.05945.27
3242254-24225445.01545.22
4244019-24401945.34345.55
5244396-24439645.41345.62
6238081-23808144.24044.43
45min1262829-26282948.83949.481.0049.1149.761.00
2267788-26778849.76050.04
3267150-26715049.64249.92
4267377-26737749.68449.97
5269302-26930250.04150.32
6263179-26317948.90449.17
60min1276782-27678251.43152.100.9651.7852.460.97
2281327-28132752.27652.64
3280786-28078652.17552.54
4280545-28054552.13152.50
5284557-28455752.87653.24
6278225-27822551.70052.05
极限1287409-28740953.40654.050.9453.8454.500.95
2292178-29217854.29254.75
3292980-29298054.44154.89
4290997-29099754.07354.53
5293965-29396554.62455.08
6287836-28783653.48553.92
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.214857144870324868734872664867994867370.13
215.184872334872164872240.01
单位质量响应值RSD%判断
32001.1232096.440.22数据可信
供试品溶液-24081201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%
5min180656-8065615.04015.333.7015.0415.333.70
280176-8017614.95014.95
380074-8007414.93114.93
482419-8241915.36815.37
581919-8191915.27515.28
688113-8811316.43016.43
10min1146877-14687727.38827.371.6927.4127.401.68
2143151-14315126.69326.72
3146303-14630327.28127.31
4145391-14539127.11127.14
5149550-14955027.88627.91
6149545-14954527.88527.91
15min1182650-18265034.05834.050.6934.1334.120.69
2181102-18110233.76933.84
3182741-18274134.07534.15
4181229-18122933.79333.86
5184063-18406334.32234.39
6183824-18382434.27734.35
20min1206359-20635938.47938.400.6338.6138.530.63
2204406-20440638.11538.24
3205975-20597538.40738.53
4206601-20660138.52438.65
5207743-20774338.73738.87
6204529-20452938.13838.27
30min1236419-23641944.08443.850.5044.2844.040.50
2235949-23594943.99744.19
3235890-23589043.98644.18
4233848-23384843.60543.80
5235249-23524943.86644.06
6233611-23361143.56143.76
45min1263402-26340249.11648.780.7049.3849.040.70
2262842-26284249.01149.27
3263167-26316749.07249.34
4259228-25922848.33748.60
5261272-26127248.71848.99
6259694-25969448.42448.69
60min1279665-27966552.14851.710.8352.5052.050.82
2279236-27923652.06852.41
3278781-27878151.98352.33
4274737-27473751.22951.57
5276790-27679051.61251.96
6274558-27455851.19651.54
极限1292032-29203254.45453.980.8154.8954.410.81
2291590-29159054.37254.80
3291035-29103554.26854.70
4286926-28692653.50253.93
5288189-28818953.73754.17
6287127-28712753.53953.97
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