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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.221720341720051721481718931717931719750.08
215.231717371715701716540.07
单位质量响应值RSD%判断
11299.2811270.780.18数据可信
供试品溶液-1231323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%
30min126091-2609113.85813.522.9013.8613.522.91
226466-2646614.05714.06
324824-2482413.18513.19
424914-2491413.23313.23
525706-2570613.65413.65
624723-2472313.13213.13
60min144864-4486423.82923.442.0723.8523.462.08
245453-4545324.14224.17
343380-4338023.04123.06
443314-4331423.00623.03
544392-4439223.57923.60
643369-4336923.03523.06
120min172394-7239438.45238.061.4838.5138.131.49
272621-7262138.57238.64
371455-7145537.95338.01
470021-7002137.19137.25
572589-7258938.55538.62
670915-7091537.66637.73
240min1109294-10929458.05158.441.0058.1858.571.00
2110022-11002258.43858.57
3110633-11063358.76258.89
4108731-10873157.75257.87
5111838-11183859.40259.53
6109667-10966758.24958.37
360min1134629-13462971.50872.531.1771.7372.751.17
2135936-13593672.20272.43
3137057-13705772.79773.02
4136747-13674772.63372.85
5139284-13928473.98074.21
6135670-13567072.06172.28
480min1154896-15489682.27383.551.3582.6283.901.35
2156303-15630383.02083.37
3157844-15784483.83884.18
4158576-15857684.22784.57
5160608-16060885.30685.66
6155634-15563482.66583.00
600min1166048-16604888.19689.421.2588.6889.901.25
2167368-16736888.89789.38
3168488-16848889.49289.97
4169879-16987990.23190.71
5171606-17160691.14891.64
6166671-16667188.52789.00
720min1172708-17270891.73393.061.3692.3693.691.36
2174073-17407392.45893.09
3175026-17502692.96593.60
4177326-17732694.18694.82
5178753-17875394.94495.59
6173350-17335092.07492.70
960min1179830-17983095.51696.881.4696.3097.671.45
2180791-18079196.02796.81
3182037-18203796.68897.48
4184861-18486198.18898.98
5186401-18640199.00699.81
6180495-18049595.86996.65
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1182482-18248296.92598.661.5997.8699.611.58
2183699-18369997.57198.52
3185737-18573798.65499.60
4188545-188545100.145101.10
5189947-189947100.890101.86
6184071-18407197.76998.71
1440min1184641-18464198.07299.441.4399.17100.551.43
2185236-18523698.38899.50
3186495-18649599.056100.17
4189704-189704100.761101.88
5191315-191315101.616102.75
6185900-18590098.74099.84
极限1184773-18477398.14299.331.5099.41100.601.50
2184848-18484898.18199.45
3186282-18628298.943100.22
4189602-189602100.707101.99
5191357-191357101.639102.94
6185177-18517798.35699.62
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.223474263466593474173468083474583471540.12
215.233475913480293478100.09
单位质量响应值RSD%判断
22809.0722837.160.09数据可信
供试品溶液-1224287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%
30min150687-5068713.31213.292.0613.3113.292.05
250756-5075613.33013.33
350872-5087213.36013.36
448581-4858112.75912.76
551483-5148313.52113.52
651270-5127013.46513.46
60min188490-8849023.24023.222.1023.2623.242.10
288829-8882923.32923.35
388735-8873523.30423.33
484803-8480322.27222.29
589862-8986223.60023.62
689718-8971823.56323.58
120min1143689-14368937.73737.942.5037.8038.002.50
2142897-14289737.52937.59
3145954-14595438.33238.39
4138506-13850636.37636.43
5146864-14686438.57138.63
6148749-14874939.06639.13
240min1218795-21879557.46257.741.9257.5957.861.93
2220813-22081357.99258.12
3220863-22086358.00558.13
4212066-21206655.69555.81
5224300-22430058.90859.03
6222223-22222358.36258.49
360min1269735-26973570.84071.492.0171.0671.712.01
2274594-27459472.11672.34
3272058-27205871.45071.67
4262849-26284969.03269.24
5278354-27835473.10473.33
6275602-27560272.38172.61
480min1307764-30776480.82881.882.1781.1782.222.17
2315023-31502382.73483.07
3312106-31210681.96882.31
4300460-30046078.90979.24
5319152-31915283.81884.16
6316154-31615483.03183.38
600min1325745-32574585.55086.882.1086.0287.352.10
2334109-33410987.74788.22
3332194-33219487.24487.72
4319516-31951683.91484.37
5338385-33838588.87089.36
6334880-33488087.94988.43
720min1337511-33751188.64089.882.1989.2590.502.19
2345754-34575490.80591.43
3343877-34387790.31290.93
4329715-32971586.59387.19
5350874-35087492.15092.78
6345630-34563090.77291.40
960min1350801-35080192.13093.472.1992.8994.242.19
2360317-36031794.63095.41
3357480-35748093.88494.66
4343000-34300090.08290.82
5364724-36472495.78796.57
6359032-35903294.29295.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1358254-35825494.08895.452.2895.0096.382.28
2366910-36691096.36197.29
3365693-36569396.04196.97
4349881-34988191.88992.78
5373791-37379198.16899.12
6366227-36622796.18297.12
1440min1363470-36347095.45896.702.1996.5397.792.19
2371949-37194997.68498.78
3369871-36987197.13998.23
4355175-35517593.27994.32
5378679-37867999.452100.56
6370144-37014497.21098.31
极限1363298-36329895.41296.712.2496.6497.962.24
2371542-37154297.57898.83
3369657-36965797.08298.33
4354941-35494193.21894.42
5379077-37907799.556100.83
6370982-37098297.43098.69
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