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%
19.753769439376441337760043778854375912137695660.22
29.793809716382198038158480.23
单位质量响应值RSD%判断
386622.15389769.970.58数据可信
供试品溶液-4226B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%
5min12220876-222087651.49056.2020.2151.4956.2020.20
22693622-269362262.45062.45
32386481-238648155.32955.33
41588058-158805836.81836.82
52998979-299897969.53069.53
62656556-265655661.59161.59
10min13571966-357196682.81484.984.7082.9385.114.72
23769922-376992287.40487.54
33568987-356898782.74582.87
43421617-342161779.32979.41
53882942-388294290.02490.18
63777249-377724987.57487.71
15min13995613-399561392.63693.561.5092.9393.881.53
24096144-409614494.96795.30
33987289-398728992.44392.75
43972642-397264292.10492.36
54117009-411700995.45195.81
64044673-404467393.77494.11
20min14172981-417298196.74996.450.5097.2596.970.52
24177560-417756096.85597.40
34145934-414593496.12296.63
44141475-414147596.01896.48
54184877-418487797.02497.59
64138410-413841095.94796.49
30min14293348-429334899.53997.800.99100.2698.530.96
24207332-420733297.54598.30
34223696-422369697.92498.65
44221890-422189097.88398.56
54187079-418707997.07697.86
64175655-417565596.81197.56
45min14315626-4315626100.05697.811.29101.0098.761.28
24188600-418860097.11198.09
34250099-425009998.53799.48
44180188-418018896.91697.81
54178353-417835396.87397.87
64198662-419866297.34498.31
60min14149324-414932496.20095.101.2997.3696.261.27
24150587-415058796.22997.42
34086114-408611494.73595.90
44104100-410410095.15296.26
54112248-411224895.34196.55
64007780-400778092.91994.10
极限14251087-425108798.56096.361.3899.9497.741.36
24137135-413713595.91897.32
34192786-419278697.20898.58
44124335-412433595.62196.94
54141351-414135196.01597.44
64089600-408960094.81696.21
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%
19.753795373380937538128883812621380293938066390.20
29.793848612384516238468870.07
单位质量响应值RSD%判断
390424.51392940.450.46数据可信
供试品溶液-4226B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%
5min12290336-229033652.62758.3614.0152.6358.3614.01
22903405-290340566.71566.71
32168694-216869449.83249.83
42854595-285459565.59365.59
52195038-219503850.43850.44
62827524-282752464.97164.97
10min13562381-356238181.85785.103.0681.9785.223.08
23800054-380005487.31887.47
33599578-359957882.71182.82
43804830-380483087.42887.57
53647288-364728883.80883.92
63805876-380587687.45287.60
15min14007747-400774792.09093.030.7892.3993.350.79
24060858-406085893.31193.65
34081956-408195693.79594.09
44067610-406761093.46693.81
54010864-401086492.16292.46
64063722-406372293.37693.72
20min14159807-415980795.58495.360.3896.0995.890.36
24132688-413268894.96195.51
34162006-416200695.63596.14
44128234-412823494.85995.41
54155534-415553495.48695.99
64163139-416313995.66196.21
30min14195990-419599096.41696.280.2897.1397.020.28
24180303-418030396.05596.82
34182522-418252296.10696.82
44209758-420975896.73297.49
54190150-419015096.28197.00
64181354-418135496.07996.84
45min14200214-420021496.51396.170.3597.4497.120.36
24177842-417784295.99996.97
34165101-416510195.70696.63
44199175-419917596.48997.46
54175906-417590695.95496.88
64193679-419367996.36297.33
60min14195119-419511996.39694.181.5797.5495.351.52
24044626-404462692.93894.13
34133284-413328494.97596.12
44054039-405403993.15494.34
54130988-413098894.92296.06
64035302-403530292.72393.91
极限14124404-412440494.77194.730.3496.1396.110.33
24099814-409981494.20695.60
34128219-412821994.85896.21
44141895-414189595.17396.57
54119111-411911194.64996.00
64123189-412318994.74396.14
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%
19.753815549384497038351173839733385008738370910.35
29.793893346390037638968610.13
单位质量响应值RSD%判断
393547.79398045.050.81数据可信
供试品溶液-4226B批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1323194-3231947.3497.2611.397.357.2611.39
2269206-2692066.1226.12
3364190-3641908.2828.28
4346043-3460437.8697.87
5284033-2840336.4596.46
6329892-3298927.5027.50
10min1618721-61872114.07013.733.4714.0913.753.48
2579330-57933013.17413.19
3623550-62355014.17914.20
4624621-62462114.20414.22
5594504-59450413.51913.53
6582549-58254913.24713.26
15min1704406-70440616.01815.512.8816.0715.562.88
2664883-66488315.11915.16
3688582-68858215.65815.71
4696524-69652415.83915.89
5684674-68467415.56915.61
6652595-65259514.84014.89
20min1717308-71730816.31116.112.9316.3916.192.93
2696208-69620815.83215.91
3727394-72739416.54116.63
4723549-72354916.45316.54
5713533-71353316.22616.30
6672290-67229015.28815.37
30min1733000-73300016.66816.622.3916.7916.742.37
2723499-72349916.45216.56
3755925-75592517.19017.31
4703484-70348415.99716.12
5739980-73998016.82716.94
6730019-73001916.60016.71
45min1705439-70543916.04117.023.8816.2017.173.86
2726292-72629216.51616.66
3783663-78366317.82017.98
4771418-77141817.54217.70
5758100-75810017.23917.39
6745249-74524916.94717.10
60min1710161-71016116.14916.087.1516.3416.277.08
2740828-74082816.84617.03
3684344-68434415.56215.76
4710797-71079716.16316.36
5771659-77165917.54717.74
6623865-62386514.18714.37
极限1767240-76724017.44717.241.9517.6717.461.92
2745785-74578516.95917.18
3752006-75200617.10017.33
4740909-74090916.84817.08
5780454-78045417.74717.98
6761912-76191217.32617.54
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%
19.753829709383695638401133829988382779038329110.14
29.793777668376142537695460.31
单位质量响应值RSD%判断
393119.08385040.451.47数据可信
供试品溶液-4226B批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338569-3385697.8327.717.037.837.707.04
2370116-3701168.5628.56
3344749-3447497.9757.98
4305357-3053577.0647.06
5326528-3265287.5547.55
6313287-3132877.2487.25
10min1579271-57927113.40113.672.5013.4213.692.50
2614449-61444914.21514.23
3602186-60218613.93113.95
4575107-57510713.30513.32
5587218-58721813.58513.60
6587995-58799513.60313.62
15min1663773-66377315.35615.491.5415.4015.541.55
2681178-68117815.75815.81
3675972-67597215.63815.69
4656866-65686615.19615.24
5678339-67833915.69315.74
6660657-66065715.28415.33
20min1687188-68718815.89715.683.4515.9815.763.44
2636543-63654314.72614.81
3677352-67735215.67015.75
4676343-67634315.64715.73
5708234-70823416.38416.47
6681497-68149715.76615.85
30min1708082-70808216.38116.052.4616.5016.172.44
2662748-66274815.33215.45
3690001-69000115.96216.08
4698068-69806816.14916.26
5709410-70941016.41116.53
6694289-69428916.06216.18
45min1664532-66453215.37316.9113.1715.5317.0713.05
2913535-91353521.13421.29
3728070-72807016.84317.00
4705569-70556916.32316.47
5732361-73236116.94217.10
6642139-64213914.85515.01
60min1673111-67311115.57216.338.5115.7616.528.43
2701829-70182916.23616.44
3816410-81641018.88719.08
4717623-71762316.60116.79
5641142-64114214.83215.02
6685910-68591015.86816.05
极限1728683-72868316.85716.562.9817.0816.782.95
2729147-72914716.86817.10
3703719-70371916.28016.51
4744280-74428017.21817.44
5700683-70068316.21016.43
6688527-68852715.92816.15
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