非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.651813967181536018163161816428181619218156530.06
29.711831699183072018312100.04
单位质量响应值RSD%判断
188150.57188590.110.17数据可信
供试品溶液-2024112321批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1705753-70575367.43964.914.0467.4464.914.04
2681357-68135765.10865.11
3685003-68500365.45765.46
4638490-63849061.01261.01
5656598-65659862.74262.74
6708230-70823067.67667.68
10min1941492-94149289.96688.913.6690.1289.063.66
2894251-89425185.45285.60
3939998-93999889.82389.97
4909762-90976286.93487.07
5988518-98851894.45994.60
6908730-90873086.83586.99
15min11000542-100054295.60893.721.8495.9694.061.84
2960240-96024091.75792.09
31004634-100463495.99996.34
4976403-97640393.30293.63
5966448-96644892.35092.70
6976312-97631293.29393.64
20min11026752-102675298.11396.301.6798.6896.851.67
2989457-98945794.54995.09
31028817-102881798.31098.87
41005735-100573596.10596.64
5992079-99207994.80095.35
61003788-100378895.91996.47
30min11042563-104256399.62497.501.86100.4098.261.86
21000302-100030295.58596.33
31041356-104135699.508100.29
41021353-102135397.59798.35
5999154-99915495.47696.24
61017280-101728097.20897.97
45min11046825-1046825100.03198.411.63101.0399.391.62
21010564-101056496.56697.53
31052460-1052460100.569101.57
41025118-102511897.95798.92
51015729-101572997.06098.04
61028465-102846598.27799.26
60min11060189-1060189101.30898.792.13102.5399.992.12
21010541-101054196.56497.74
31061591-1061591101.442102.66
41027784-102778498.21299.40
51015466-101546697.03498.23
61027494-102749498.18499.38
极限11078958-1078958103.10299.632.26104.55101.042.25
21008649-100864996.38397.77
31051294-1051294100.458101.90
41042403-104240399.608101.01
51028042-102804298.23699.64
61046229-104622999.974101.39
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.651878941188051518790681878337187539318784510.11
29.711854679185495418548160.02
单位质量响应值RSD%判断
194658.13191021.221.34数据可信
供试品溶液-b批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1706743-70674365.97568.594.5465.9768.584.54
2729657-72965768.11468.11
3685657-68565764.00664.01
4769477-76947771.83171.83
5757936-75793670.75370.75
6758842-75884270.83870.84
10min1944645-94464588.18388.851.1988.3389.001.19
2961285-96128589.73689.89
3932998-93299887.09587.24
4952390-95239088.90689.07
5962302-96230289.83189.99
6956916-95691689.32889.49
15min11000181-100018193.36794.340.9193.7194.690.91
21019624-101962495.18295.53
31003456-100345693.67394.01
41007190-100719094.02194.38
51023299-102329995.52595.88
61009696-100969694.25594.61
20min11065461-106546199.46198.172.20100.0198.732.18
21039348-103934897.02397.59
31089652-1089652101.719102.26
41029779-102977996.13096.70
51053754-105375498.36898.94
61031728-103172896.31296.88
30min11094787-1094787102.19899.982.56102.97100.752.53
21055915-105591598.57099.35
31114266-1114266104.017104.79
41046629-104662997.70398.48
51063734-106373499.300100.09
61050483-105048398.06398.84
45min11094541-1094541102.175100.672.04103.17101.672.02
21062363-106236399.172100.17
31113261-1113261103.923104.92
41054599-105459998.44799.44
51077969-1077969100.629101.64
61067588-106758899.659100.66
60min11090463-1090463101.795100.711.79103.02101.931.78
21082347-1082347101.037102.25
31109056-1109056103.530104.76
41060319-106031998.981100.20
51072487-1072487100.117101.35
61058435-105843598.805100.02
极限11144574-1144574106.846101.493.12108.30102.933.09
21075610-1075610100.408101.85
31105669-1105669103.214104.68
41056748-105674898.648100.08
51085535-1085535101.335102.79
61054771-105477198.46399.90
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.651825479182565218234821825181182562718250840.06
29.711826919182592518264220.04
单位质量响应值RSD%判断
189127.88188097.010.39数据可信
供试品溶液-2024112421批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1614953-61495358.68859.959.1958.6959.949.19
2677676-67767664.67464.67
3623506-62350659.50459.50
4705459-70545967.32567.33
5541580-54158051.68551.69
6605597-60559757.79557.79
10min1915857-91585787.40488.443.6387.5388.573.62
2945990-94599090.28090.42
3935347-93534789.26489.40
4901257-90125786.01186.16
5884044-88404484.36884.48
6977646-97764693.30193.43
15min11038615-103861599.12095.222.7399.4495.552.71
2984875-98487593.99194.34
31014270-101427096.79697.13
4970684-97068492.63792.98
51007733-100773396.17296.47
6970455-97045592.61592.95
20min11048906-1048906100.10297.062.75100.6597.602.74
21037993-103799399.06099.61
31039719-103971999.22599.77
4993947-99394794.85795.40
5994636-99463694.92395.44
6987303-98730394.22394.76
30min11071949-1071949102.30198.932.89103.0799.692.88
21053607-1053607100.550101.32
31064674-1064674101.607102.37
41010983-101098396.48397.24
51010822-101082296.46797.19
61008001-100800196.19896.95
45min11078103-1078103102.88899.412.90103.88100.382.89
21060555-1060555101.214102.21
31067105-1067105101.839102.83
41012132-101213296.59297.56
51016649-101664997.02397.96
61015154-101515496.88197.85
60min11083784-1083784103.43099.932.75104.65101.122.74
21066126-1066126101.745102.97
31067975-1067975101.922103.14
41019490-101949097.29598.48
51025781-102578197.89599.05
61019224-101922497.26998.45
极限11080831-1080831103.149101.694.29104.60103.104.24
21061358-1061358101.290102.74
31075373-1075373102.628104.07
41015379-101537996.90298.30
51020363-102036397.37898.75
61139811-1139811108.777110.17
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