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101278-202405对照品来源中检院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%
19.653875171387863938791333881352387392438776440.08
29.823951488395667539540820.10
单位质量响应值RSD%判断
401828.39402656.010.15数据可信
供试品溶液-20200709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%
5min11703112-170311238.06856.6125.2838.0756.6125.28
23165080-316508070.74770.75
33022082-302208267.55067.55
42780886-278088662.15962.16
51756082-175608239.25239.25
62768916-276891661.89161.89
10min13898170-389817087.13390.314.5187.2290.434.54
24210258-421025894.10994.27
34184970-418497093.54393.69
44162239-416223993.03593.17
53755843-375584383.95184.04
64029779-402977990.07590.21
15min14223960-422396094.41593.971.4394.6994.301.45
24222943-422294394.39294.76
34244836-424483694.88295.24
44217270-421727094.26594.61
54083631-408363191.27891.55
64232045-423204594.59694.93
20min14337196-433719696.94695.531.1697.4396.061.16
24277489-427748995.61196.19
34320726-432072696.57897.15
44267311-426731195.38495.94
54216365-421636594.24594.72
64223395-422339594.40294.95
30min14351113-435111397.25795.241.2397.9695.981.22
24249666-424966694.99095.78
34284225-428422595.76296.55
44251392-425139295.02895.79
54202435-420243593.93494.62
64225824-422582494.45795.21
45min14343078-434307897.07795.111.1098.0096.071.08
24246186-424618694.91295.91
34262550-426255095.27796.27
44233144-423314494.62095.60
54238613-423861394.74295.64
64207948-420794894.05795.02
极限14332820-433282096.84894.981.0697.9896.151.04
24234061-423406194.64195.85
34264714-426471495.32696.53
44224282-422428294.42295.61
54209778-420977894.09895.20
64229868-422986894.54795.72
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101278-202405对照品来源中检院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%
19.653969839396767239687483966717396740939680770.04
29.823982037397848339802600.07
单位质量响应值RSD%判断
411199.69405321.791.02数据可信
供试品溶液-20200709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%
5min12594508-259450857.14158.8822.7457.1458.8822.75
23130475-313047568.94568.95
32581096-258109656.84656.85
41549371-154937134.12334.12
53158214-315821469.55669.56
63028124-302812466.69166.69
10min14184231-418423192.15389.993.5892.2890.123.59
24106010-410601090.43090.58
33910738-391073886.12986.26
43897112-389711285.82985.91
54207537-420753792.66692.82
64209754-420975492.71592.86
15min14239610-423961093.37292.990.8993.7093.320.90
24250339-425033993.60993.96
34163794-416379491.70392.02
44200646-420064692.51492.78
54213239-421323992.79293.15
64265468-426546893.94294.30
20min14247600-424760093.54893.851.0594.0994.391.04
24314609-431460995.02495.59
34220027-422002792.94193.46
44309121-430912194.90395.38
54207798-420779892.67293.24
64267810-426781093.99494.56
30min14217790-421779092.89293.601.2393.6494.341.19
24246837-424683793.53294.30
34263701-426370193.90394.63
44338081-433808195.54196.22
54181831-418183192.10092.87
64250645-425064593.61594.39
45min14214408-421440892.81793.341.0693.7794.291.02
24224428-422442893.03894.02
34280763-428076394.27995.22
44303311-430331194.77595.67
54183062-418306292.12793.10
64222660-422266092.99993.98
极限14191440-419144092.31292.961.0693.4794.121.02
24225131-422513193.05494.24
34235720-423572093.28794.43
44298180-429818094.66295.77
54170580-417058091.85293.03
64204043-420404392.58993.78
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101278-202405对照品来源中检院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%
19.653952057395581739579633949859395013639531660.10
29.823843017381865738308370.45
单位质量响应值RSD%判断
409654.51390105.603.46数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-20200710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%
5min11900333-190033342.75358.5515.6242.7558.5415.62
22817271-281727163.38263.38
32876000-287600064.70364.70
42631136-263113659.19459.19
52383523-238352353.62453.62
63006008-300600867.62867.63
10min13550438-355043879.87791.206.4979.9791.336.50
24208006-420800694.67094.81
34166261-416626193.73193.88
44126861-412686192.84592.98
53999122-399912289.97190.09
64270984-427098496.08796.24
15min14068595-406859591.53494.441.9191.8194.771.93
24267174-426717496.00296.35
34169012-416901293.79394.15
44186970-418697094.19794.53
54199261-419926194.47494.79
64295899-429589996.64897.01
20min14192233-419223394.31694.861.0894.7995.401.09
24249402-424940295.60296.17
34178991-417899194.01894.58
44185257-418525794.15994.71
54198996-419899694.46895.00
64293590-429359096.59697.17
30min14219700-421970094.93395.191.0895.6295.941.09
24270785-427078596.08396.86
34190372-419037294.27495.04
44196119-419611994.40395.16
54205957-420595794.62495.36
64302459-430245996.79597.59
45min14232433-423243395.22095.011.0096.1295.981.00
24260885-426088595.86096.85
34176603-417660393.96494.94
44179606-417960694.03195.00
54211255-421125594.74395.69
64278684-427868496.26097.27
极限14198499-419849994.45794.821.3295.5696.001.33
24283351-428335196.36597.57
34164990-416499093.70394.89
44169957-416995793.81494.99
54185447-418544794.16395.32
64285889-428588996.42397.64
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101278-202405对照品来源中检院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%
19.653858870385572938572013864577385650838585770.10
29.824007623400575240066880.04
单位质量响应值RSD%判断
399852.54408013.031.43数据可信
供试品溶液-20200710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%
5min12851196-285119663.47056.6021.6563.4756.6021.65
22957014-295701465.82665.83
32196095-219609548.88748.89
42998261-299826166.74466.74
52662139-266213959.26259.26
61591005-159100535.41735.42
10min14219758-421975893.93689.747.2394.0889.867.25
24196128-419612893.41093.56
34031638-403163889.74889.86
44177934-417793493.00593.15
54108079-410807991.45091.58
63453221-345322176.87276.95
15min14337212-433721296.55093.662.6396.9093.982.66
24239501-423950194.37594.73
34268424-426842495.01995.33
44226155-422615594.07894.43
54156668-415666892.53192.87
64015950-401595089.39989.65
20min14325946-432594696.30094.111.6496.8694.641.65
24244759-424475994.49295.06
34273582-427358295.13495.65
44216631-421663193.86694.43
54139211-413921192.14392.68
64165579-416557992.73093.18
30min14339250-433925096.59694.441.5797.3795.181.57
24234499-423449994.26495.04
34290854-429085495.51896.25
44208185-420818593.67894.45
54146875-414687592.31393.06
64235112-423511294.27894.93
45min14317187-431718796.10594.301.4597.1095.251.46
24226362-422636294.08395.07
34280975-428097595.29896.24
44247032-424703294.54395.52
54141620-414162092.19693.15
64202871-420287193.56094.42
极限14289585-428958595.49093.791.5296.7094.951.51
24196770-419677093.42494.62
34250626-425062694.62395.78
44199993-419999393.49694.69
54103150-410315091.34092.50
64238543-423854394.35495.43
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