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250
标示量(mg)40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%
110.041925280192658419263901926602192604319261800.03
210.171954110195461619543630.02
单位质量响应值RSD%判断
191850.60192169.420.12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%
5min11148520-114852053.83442.5922.4153.8342.5922.41
21018290-101829047.73047.73
3718327-71832733.67033.67
4648716-64871630.40730.41
5839137-83913739.33339.33
61079366-107936650.59350.59
10min11819890-181989085.30380.805.0985.4280.895.11
21788988-178898883.85483.96
31701410-170141079.74979.82
41594675-159467574.74774.81
51656595-165659577.64977.74
61781134-178113483.48683.60
15min11998364-199836493.66892.331.2493.9892.611.24
21951958-195195891.49391.79
31998748-199874893.68693.94
41939579-193957990.91391.15
51968090-196809092.24992.51
61962406-196240691.98392.28
20min12052047-205204796.18596.041.2396.7096.521.21
22023011-202301194.82495.32
32086438-208643897.79798.26
42060238-206023896.56997.00
52053334-205333496.24596.71
62018689-201868994.62195.12
30min12107945-210794598.80598.691.5399.5499.391.50
22074814-207481497.25297.96
32150805-2150805100.814101.49
42123128-212312899.517100.17
52113356-211335699.05899.74
62063179-206317996.70797.42
45min12131381-213138199.90399.881.72100.85100.791.69
22103638-210363898.60399.53
32181556-2181556102.255103.16
42154028-2154028100.965101.84
52136218-2136218100.130101.03
62077909-207790997.39798.32
60min12126049-212604999.653100.331.50100.83101.461.47
22098287-209828798.35299.49
32187805-2187805102.548103.68
42162746-2162746101.374102.47
52146003-2146003100.589101.71
62121431-212143199.437100.58
极限12138889-2138889100.255100.451.60101.65101.801.57
22107855-210785598.801100.16
32193991-2193991102.838104.19
42164353-2164353101.449102.77
52148065-2148065100.685102.03
62104525-210452598.645100.01
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250
标示量(mg)40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%
110.041929207193045819290701928851192849119292150.04
210.171955411195623419558220.03
单位质量响应值RSD%判断
192152.89192312.880.06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%
5min1836302-83630239.15439.4124.9939.1539.4124.98
21115623-111562352.23152.23
31083853-108385350.74450.74
4650183-65018330.44030.44
5688535-68853532.23632.24
6676416-67641631.66931.67
10min11734175-173417581.19180.317.3381.2880.397.35
21847352-184735286.49086.61
31877424-187742487.89888.01
41587009-158700974.30174.37
51648559-164855977.18377.25
61597076-159707674.77274.84
15min11980424-198042492.72093.671.7292.9993.941.74
22003865-200386593.81794.13
32066171-206617196.73497.04
42001072-200107293.68793.92
51977950-197795092.60492.85
61975241-197524192.47792.71
20min12064856-206485696.67397.511.4097.1597.981.42
22080735-208073597.41697.93
32139924-2139924100.187100.71
42077684-207768497.27397.71
52071708-207170896.99497.44
62060940-206094096.49096.93
30min12129786-212978699.713100.921.20100.40101.611.20
22135038-213503899.959100.69
32191921-2191921102.622103.37
42182780-2182780102.194102.85
52146572-2146572100.499101.16
62147174-2147174100.527101.18
45min12153438-2153438100.820102.131.22101.73103.041.22
22161556-2161556101.200102.16
32221687-2221687104.015104.99
42205136-2205136103.241104.12
52170609-2170609101.624102.51
62175777-2175777101.866102.75
60min12166423-2166423101.428102.481.09102.56103.621.08
22170062-2170062101.598102.78
32221061-2221061103.986105.19
42214508-2214508103.679104.79
52173095-2173095101.740102.85
62188574-2188574102.465103.57
极限12169044-2169044101.551102.711.07102.91104.081.06
22172163-2172163101.697103.10
32225515-2225515104.195105.63
42215898-2215898103.744105.09
52182665-2182665102.188103.53
62197371-2197371102.877104.21
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250
标示量(mg)40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%
110.041930314193010319312291930008193044519304200.03
210.171965406196497219651890.02
单位质量响应值RSD%判断
192272.91193233.920.36数据可信
供试品溶液-2024112422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%
5min1815589-81558938.08241.5815.8938.0841.5815.89
2705687-70568732.95032.95
31062405-106240549.60649.61
4945115-94511544.12944.13
5790410-79041036.90636.91
61023810-102381047.80447.80
10min11699135-169913579.33680.945.8679.4281.035.87
21556687-155668772.68572.76
31827623-182762385.33685.45
41809430-180943084.48684.58
51711431-171143179.91079.99
61796503-179650383.88283.99
15min11970177-197017791.99292.202.1092.2592.472.12
21902009-190200988.80989.04
32013653-201365394.02294.32
42002668-200266893.50993.79
51958392-195839291.44191.70
62001056-200105693.43393.73
20min12055686-205568695.98496.111.1196.4596.591.14
22021380-202138094.38294.81
32081519-208151997.19097.70
42074920-207492096.88297.38
52044147-204414795.44595.91
62073266-207326696.80597.31
30min12115206-211520698.76398.760.8499.4499.460.87
22087832-208783297.48598.13
32134416-213441699.660100.39
42129909-212990999.450100.16
52101626-210162698.12998.80
62122297-212229799.09499.81
45min12141398-214139899.98699.730.61100.88100.640.63
22118165-211816598.90299.76
32130033-213003399.456100.40
42152835-2152835100.520101.45
52126818-212681899.306100.20
62145768-2145768100.190101.13
60min12149869-2149869100.382100.290.67101.50101.420.69
22129490-212949099.430100.51
32164729-2164729101.076102.24
42160213-2160213100.865102.02
52132961-213296199.592100.71
62149874-2149874100.382101.54
极限12146980-2146980100.247100.280.71101.59101.640.72
22134817-213481799.679100.98
32170187-2170187101.331102.72
42157733-2157733100.749102.13
52128631-212863199.390100.73
62147747-2147747100.283101.66
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