非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.153895459389381138936653895598389168238940430.05
210.253962072395888739604800.06
单位质量响应值RSD%判断
383649.56386388.290.51数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min11613266-161326637.71134.1024.4037.7134.1024.40
2983382-98338222.98722.99
31649016-164901638.54738.55
41029836-102983624.07324.07
51795834-179583441.97941.98
61681764-168176439.31339.31
10min13510028-351002882.05078.327.4982.1178.377.51
23052915-305291571.36471.40
33474806-347480681.22681.29
43021108-302110870.62170.66
53616857-361685784.54784.62
63426428-342642880.09580.16
15min14147805-414780596.95894.833.3397.1695.023.35
23830824-383082489.54889.71
34186295-418629597.85898.06
43986010-398601093.17693.33
54154551-415455197.11697.33
64034108-403410894.30094.50
20min14312538-4312538100.809100.081.89101.17100.421.90
24152672-415267297.07297.38
34395633-4395633102.751103.11
44274965-427496599.931100.24
54305367-4305367100.641101.01
64246046-424604699.25599.61
30min14378188-4378188102.344102.771.81102.87103.281.82
24320851-4320851101.003101.47
34550235-4550235106.365106.90
44392314-4392314102.674103.15
54381835-4381835102.429102.97
64355147-4355147101.805102.33
45min14387758-4387758102.567102.631.28103.27103.311.28
24334887-4334887101.331101.97
34490273-4490273104.964105.67
44407183-4407183103.021103.67
54377442-4377442102.326103.04
64344516-4344516101.556102.25
60min14381700-4381700102.426102.331.26103.30103.181.26
24317540-4317540100.926101.73
34474204-4474204104.588105.47
44392299-4392299102.673103.50
54361901-4361901101.963102.84
64337587-4337587101.394102.25
极限14369330-4369330102.136102.181.29103.18103.201.30
24314260-4314260100.849101.82
34473773-4473773104.578105.64
44379112-4379112102.365103.36
54362728-4362728101.982103.03
64327613-4327613101.161102.19
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.153919414392434639230983924980392490839233490.06
210.253954554395534739549500.02
单位质量响应值RSD%判断
386536.85385848.780.13数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min11291672-129167230.10239.2118.2330.1039.2118.23
21551187-155118736.15036.15
32038031-203803147.49547.50
41791338-179133841.74641.75
51428716-142871633.29533.30
61994570-199457046.48246.48
10min13012916-301291670.21479.007.8870.2679.077.89
23178010-317801074.06274.12
33671445-367144585.56185.64
43511358-351135881.83081.90
53313289-331328977.21477.27
63653435-365343585.14185.22
15min13915854-391585491.25793.773.2091.4293.963.22
23948796-394879692.02492.21
34089495-408949595.30395.53
44047243-404724394.31994.52
53902220-390222090.93991.12
64237634-423763498.75698.98
20min14194108-419410897.74198.202.2098.0698.552.21
24167916-416791697.13197.47
34205036-420503697.99698.38
44187139-418713997.57997.94
54132679-413267996.31096.65
64395298-4395298102.430102.81
30min14294333-4294333100.077100.012.08100.56100.522.08
24249490-424949099.03299.53
34259127-425912799.25799.80
44240298-424029898.81899.34
54237204-423720498.74699.24
64468087-4468087104.126104.68
45min14290511-429051199.98899.972.06100.64100.652.07
24251550-425155099.08099.74
34252966-425296699.11399.82
44238585-423858598.77899.47
54239151-423915198.79199.45
64465778-4465778104.072104.80
60min14284446-428444699.84799.682.11100.66100.532.12
24237429-423742998.75199.58
34242916-424291698.87999.75
44222495-422249598.40399.26
54221105-422110598.37099.20
64455097-4455097103.824104.73
极限14268264-426826499.47099.432.14100.45100.442.15
24224423-422442398.44899.44
34228018-422801898.53299.57
44215418-421541898.23899.26
54214472-421447298.21699.21
64448485-4448485103.669104.74
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.153945984394700539397273937391393623139412680.13
210.253981552397979739806740.04
单位质量响应值RSD%判断
388302.27388358.440.02数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min12125313-212531349.25742.2215.5149.2642.2215.51
21858170-185817043.06543.07
32051749-205174947.55247.55
41562697-156269736.21736.22
51928596-192859644.69744.70
61404281-140428132.54632.55
10min13650447-365044784.60379.406.7884.6979.476.78
23405908-340590878.93679.01
33642190-364219084.41284.49
43092763-309276371.67871.74
53549695-354969582.26882.34
63213659-321365974.48074.53
15min14089594-408959494.78192.052.7495.0092.262.75
23987747-398774792.42192.62
34042455-404245593.68993.91
43793875-379387587.92788.11
54021386-402138693.20093.41
63896533-389653390.30790.48
20min14218140-421814097.76096.431.2598.1496.791.27
24207228-420722897.50797.86
34167379-416737996.58496.96
44094232-409423294.88995.21
54175478-417547896.77197.14
64103103-410310395.09495.42
30min14279679-427967999.18698.270.9799.7398.780.98
24296315-429631599.572100.09
34220494-422049497.81598.35
44217576-421757697.74798.23
54237780-423778098.21598.74
64188325-418832597.06997.56
45min14277470-427747099.13598.191.0499.8498.871.04
24298314-429831499.618100.30
34216166-421616697.71498.41
44216162-421616297.71498.36
54232294-423229498.08898.78
64180138-418013896.87997.53
60min14264456-426445698.83497.990.8799.7198.840.87
24283861-428386199.283100.14
34200828-420082897.35998.22
44201048-420104897.36498.17
54213964-421396497.66398.52
64205376-420537697.46498.28
极限14252825-425282598.56497.921.0799.6098.931.06
24275586-427558699.092100.11
34187944-418794497.06098.09
44263150-426315098.80399.78
54204648-420464897.44898.47
64165196-416519696.53397.51
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.153992348399169139874423986790398178639880110.11
210.253994925399664139957830.04
单位质量响应值RSD%判断
392907.49389832.490.56数据可信
稳定性36月-长期36月-供试品溶液-2011707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%
5min11714709-171470939.43241.186.1039.4341.186.10
21837973-183797342.26742.27
31939783-193978344.60844.61
41796840-179684041.32141.32
51624407-162440737.35637.36
61831225-183122542.11242.11
10min13448007-344800779.29277.563.7979.3677.633.79
23275264-327526475.32075.39
33519907-351990780.94681.02
43203045-320304573.65973.73
53308677-330867776.08876.15
63480733-348073380.04580.11
15min13968002-396800291.25090.581.3291.4590.781.33
23955051-395505190.95291.15
34016531-401653192.36692.58
43885006-388500689.34289.53
53880776-388077689.24489.43
63928994-392899490.35390.56
20min14106493-410649394.43595.151.1394.7895.501.13
24213635-421363596.89997.25
34155545-415554595.56395.93
44124646-412464694.85295.19
54146858-414685895.36395.70
64078531-407853193.79294.15
30min14172432-417243295.95197.011.6396.4697.521.62
24317412-431741299.28599.79
34213286-421328696.89197.41
44219515-421951597.03497.53
54266140-426614098.10698.60
64122148-412214894.79595.31
45min14168793-416879395.86897.051.7396.5397.721.71
24325004-432500499.460100.13
34202523-420252396.64397.33
44228298-422829897.23697.90
54274606-427460698.30198.96
64123255-412325594.82095.49
60min14157397-415739795.60696.701.8196.4397.521.80
24310740-431074099.13299.97
34183193-418319396.19997.04
44211213-421121396.84397.67
54266173-426617398.10798.93
64100010-410001094.28695.11
极限14145080-414508095.32296.491.8196.3197.481.80
24304212-430421298.98299.99
34173987-417398795.98796.99
44201357-420135796.61697.60
54255299-425529997.85798.84
64094293-409429394.15495.14
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