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101278-202104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)20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%
5min11703112-170311238.10656.6725.2838.1156.6725.28
23165080-316508070.81770.82
33022082-302208267.61867.62
42780886-278088662.22162.22
51756082-175608239.29239.29
62768916-276891661.95361.95
10min13898170-389817087.22090.404.5187.3090.524.54
24210258-421025894.20394.36
34184970-418497093.63793.79
44162239-416223993.12893.27
53755843-375584384.03584.12
64029779-402977990.16590.30
15min14223960-422396094.50994.071.4394.7994.391.45
24222943-422294394.48794.85
34244836-424483694.97795.33
44217270-421727094.36094.70
54083631-408363191.37091.64
64232045-423204594.69095.03
20min14337196-433719697.04395.621.1697.5396.161.15
24277489-427748995.70796.28
34320726-432072696.67597.24
44267311-426731195.47996.03
54216365-421636594.33994.82
64223395-422339594.49795.05
30min14351113-435111397.35495.331.2398.0696.081.22
24249666-424966695.08595.87
34284225-428422595.85896.64
44251392-425139295.12395.89
54202435-420243594.02894.71
64225824-422582494.55195.31
45min14343078-434307897.17595.211.1098.1096.171.08
24246186-424618695.00796.01
34262550-426255095.37396.37
44233144-423314494.71595.69
54238613-423861394.83795.73
64207948-420794894.15195.12
极限14332820-433282096.94595.081.0698.0896.251.04
24234061-423406194.73595.95
34264714-426471495.42196.63
44224282-422428294.51795.71
54209778-420977894.19295.30
64229868-422986894.64295.82
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101278-202104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)20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%
5min12594508-259450857.19858.9422.7457.2058.9422.74
23130475-313047569.01469.01
32581096-258109656.90356.90
41549371-154937134.15734.16
53158214-315821469.62669.63
63028124-302812466.75866.76
10min14184231-418423192.24590.083.5892.3790.213.60
24106010-410601090.52190.67
33910738-391073886.21686.34
43897112-389711285.91585.99
54207537-420753792.75992.91
64209754-420975492.80892.96
15min14239610-423961093.46693.080.8993.8093.410.91
24250339-425033993.70294.06
34163794-416379491.79492.11
44200646-420064692.60792.87
54213239-421323992.88593.25
64265468-426546894.03694.39
20min14247600-424760093.64293.941.0594.1894.481.03
24314609-431460995.11995.68
34220027-422002793.03493.56
44309121-430912194.99895.47
54207798-420779892.76593.33
64267810-426781094.08894.65
30min14217790-421779092.98593.691.2393.7394.441.19
24246837-424683793.62594.40
34263701-426370193.99794.73
44338081-433808195.63796.32
54181831-418183192.19292.97
64250645-425064593.70994.48
45min14214408-421440892.91093.431.0693.8694.391.02
24224428-422442893.13194.11
34280763-428076394.37395.31
44303311-430331194.87095.77
54183062-418306292.21993.20
64222660-422266093.09294.07
极限14191440-419144092.40493.051.0693.5694.221.02
24225131-422513193.14794.34
34235720-423572093.38094.53
44298180-429818094.75795.86
54170580-417058091.94493.13
64204043-420404392.68293.87
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101278-202104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)20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%
19.653847324384479138532773849948384981238490300.09
29.823930721392623739284790.09
单位质量响应值RSD%判断
398863.21400048.780.21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%
5min11910501-191050143.04558.6715.5043.0458.6715.50
22820972-282097263.55863.56
32873120-287312064.73364.73
42645672-264567259.60959.61
52372576-237257653.45653.46
63002321-300232167.64467.64
10min13535285-353528579.65290.916.4779.7591.046.48
24180595-418059594.19294.33
34148891-414889193.47793.62
44109609-410960992.59292.72
53981808-398180889.71389.83
64252783-425278395.81895.97
15min14064347-406434791.57394.221.9391.8594.551.95
24237297-423729795.46995.82
34162461-416246193.78394.13
44164536-416453693.83094.17
54160846-416084693.74794.06
64302127-430212796.93097.29
20min14179276-417927694.16294.781.1694.6495.321.18
24232156-423215695.35395.92
34167362-416736293.89494.45
44168431-416843193.91894.46
54199428-419942894.61695.14
64292485-429248596.71397.29
30min14205577-420557794.75594.861.0695.4495.611.07
24244167-424416795.62496.40
34164665-416466593.83394.60
44167695-416769593.90194.66
54198938-419893894.60595.34
64279215-427921596.41497.21
45min14204788-420478894.73794.681.0395.6395.641.04
24226081-422608195.21796.20
34163481-416348193.80694.78
44163527-416352793.80794.77
54181797-418179794.21995.17
64274679-427467996.31197.32
极限14181640-418164094.21594.681.3095.3295.851.31
24269992-426999296.20697.40
34161537-416153793.76294.95
44151111-415111193.52794.70
54176843-417684394.10795.26
64272723-427272396.26797.49
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101278-202104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)20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
29.824018589401619140173900.05
单位质量响应值RSD%判断
399852.54409102.851.62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%
5min12851196-285119663.45056.5821.6563.4556.5821.65
22957014-295701465.80565.80
32196095-219609548.87248.87
42998261-299826166.72366.72
52662139-266213959.24359.24
61591005-159100535.40635.41
10min14219758-421975893.90689.717.2394.0589.847.25
24196128-419612893.38093.53
34031638-403163889.71989.83
44177934-417793492.97593.12
54108079-410807991.42091.55
63453221-345322176.84776.93
15min14337212-433721296.52093.632.6396.8793.962.66
24239501-423950194.34594.70
34268424-426842494.98995.30
44226155-422615594.04894.40
54156668-415666892.50292.84
64015950-401595089.37089.62
20min14325946-432594696.26994.081.6496.8394.611.65
24244759-424475994.46295.03
34273582-427358295.10495.62
44216631-421663193.83694.40
54139211-413921192.11392.65
64165579-416557992.70093.15
30min14339250-433925096.56594.411.5797.3495.151.57
24234499-423449994.23495.01
34290854-429085495.48896.22
44208185-420818593.64894.42
54146875-414687592.28493.03
64235112-423511294.24794.90
45min14317187-431718796.07494.271.4597.0795.221.46
24226362-422636294.05395.04
34280975-428097595.26896.21
44247032-424703294.51395.49
54141620-414162092.16793.12
64202871-420287193.53094.39
极限14289585-428958595.46093.761.5296.6794.921.51
24196770-419677093.39494.59
34250626-425062694.59395.75
44199993-419999393.46694.66
54103150-410315091.31192.47
64238543-423854394.32495.40
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