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%
110.193929371393068339276643919732391771239250320.16
210.334010583401154840110660.02
单位质量响应值RSD%判断
385184.69388292.930.57数据可信
供试品溶液-2024031421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1391945-3919459.1219.7016.439.129.7016.41
2512228-51222811.92111.92
3425072-4250729.8929.89
4303237-3032377.0577.06
5427638-4276389.9529.95
6441978-44197810.28610.29
10min1798714-79871418.58819.017.9318.6019.037.93
2889661-88966120.70420.72
3832442-83244219.37319.39
4698958-69895816.26616.28
5837967-83796719.50119.52
6843789-84378919.63719.65
15min11061118-106111824.69424.575.5724.7424.625.58
21099474-109947425.58725.64
31066259-106625924.81424.86
4939484-93948421.86421.90
51087708-108770825.31325.36
61081736-108173625.17425.22
20min11233462-123346228.70528.203.5928.7928.293.60
21229409-122940928.61128.71
31221774-122177428.43328.52
41123806-112380626.15326.23
51226601-122660128.54528.64
61235782-123578228.75928.85
30min11345429-134542931.31130.651.5331.4530.781.54
21318057-131805730.67430.82
31300260-130026030.26030.40
41289007-128900729.99830.12
51328856-132885630.92531.06
61319982-131998230.71830.86
45min11357358-135735831.58831.251.2231.7831.441.22
21331479-133147930.98631.18
31329951-132995130.95031.14
41346007-134600731.32431.49
51365856-136585631.78631.98
61325755-132575530.85331.04
60min11346971-134697131.34731.252.0831.5931.492.06
21317095-131709530.65130.90
31323707-132370730.80531.04
41366058-136605831.79132.01
51384366-138436632.21732.46
61318862-131886230.69230.93
极限11342417-134241731.24131.082.5131.5331.372.48
21292759-129275930.08530.38
31325992-132599230.85831.15
41363252-136325231.72532.00
51381032-138103232.13932.44
61307277-130727730.42330.72
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%
110.193961412396215039617283964093396225839623280.03
210.333996861401051040036860.25
单位质量响应值RSD%判断
388844.75387578.510.24数据可信
供试品溶液-2024031421批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110067-100670.2330.3215.860.230.3216.19
215095-150950.3500.35
316390-163900.3800.38
413488-134880.3130.31
512872-128720.2980.30
614241-142410.3300.33
10min132560-325600.7550.786.120.760.786.24
235268-352680.8180.82
334904-349040.8090.81
430363-303630.7040.70
532495-324950.7530.75
635539-355390.8240.82
15min140864-408640.9470.976.160.950.976.32
240965-409650.9500.95
340591-405910.9410.94
446777-467771.0841.09
539523-395230.9160.92
641472-414720.9610.96
20min143867-438671.0170.963.731.020.973.69
241634-416340.9650.97
341928-419280.9720.98
439507-395070.9160.92
540333-403330.9350.94
642508-425080.9850.99
30min143536-435361.0090.956.691.010.956.76
242408-424080.9830.99
340953-409530.9490.95
435717-357170.8280.83
540433-404330.9370.94
641875-418750.9710.98
45min143496-434961.0080.954.621.010.964.52
241571-415710.9640.97
339624-396240.9190.93
438274-382740.8870.89
540619-406190.9420.95
642410-424100.9830.99
60min142377-423770.9820.974.830.990.985.01
240729-407290.9440.95
339876-398760.9240.93
445641-456411.0581.07
541131-411310.9540.96
642494-424940.9850.99
极限143403-434031.0060.992.711.021.002.93
242455-424550.9840.99
341832-418320.9700.98
444704-447041.0361.05
541474-414740.9620.97
642635-426350.9881.00
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%
110.194009282401013340096634010792401201140103760.03
210.334062858404426740535620.33
单位质量响应值RSD%判断
393559.96392406.780.21数据可信
供试品溶液-2024031421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%
5min1380791-3807918.7218.0410.568.728.0410.58
2336409-3364097.7047.70
3290114-2901146.6446.64
4342182-3421827.8377.84
5363366-3633668.3228.32
6393676-3936769.0169.02
10min1632776-63277614.49214.143.8214.5114.153.82
2594883-59488313.62413.64
3582826-58282613.34813.36
4618369-61836914.16214.17
5637041-63704114.58914.60
6638549-63854914.62414.64
15min1720776-72077616.50716.421.6816.5516.461.68
2706914-70691416.19016.23
3698076-69807615.98716.02
4720337-72033716.49716.53
5729207-72920716.70016.74
6726092-72609216.62916.67
20min1764931-76493117.51817.371.3517.5817.431.36
2749288-74928817.16017.22
3745024-74502417.06217.12
4754834-75483417.28717.35
5771421-77142117.66717.73
6764269-76426917.50317.57
30min1797482-79748218.26418.300.6818.3618.400.70
2801535-80153518.35718.45
3792776-79277618.15618.24
4797470-79747018.26318.36
5808730-80873018.52118.62
6797443-79744318.26318.36
45min1827008-82700818.94018.772.9819.0718.902.96
2822648-82264818.84018.96
3834367-83436719.10819.23
4772570-77257017.69317.82
5841583-84158319.27419.40
6819964-81996418.77918.91
60min1816396-81639618.69718.961.7818.8519.111.75
2833948-83394819.09919.25
3839739-83973919.23219.38
4847691-84769119.41419.57
5815162-81516218.66918.83
6813064-81306418.62118.78
极限1801085-80108518.34619.143.3818.5319.333.36
2855495-85549519.59219.78
3805145-80514518.43918.62
4865438-86543819.82020.01
5858665-85866519.66519.85
6828868-82886818.98319.17
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%
110.194043221404377140437084044596404048640431560.04
210.334086096408524340856700.02
单位质量响应值RSD%判断
396776.84395515.000.23数据可信
供试品溶液-2024031421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%
5min12606812-260681259.22454.117.5959.2254.117.58
22209502-220950250.19850.20
32499825-249982556.79356.79
42226758-222675850.59050.59
52224008-222400850.52750.53
62523009-252300957.32057.32
10min14195565-419556595.31990.475.8595.4290.565.85
24169373-416937394.72494.81
33787965-378796586.05986.15
43902328-390232888.65788.74
53655927-365592783.05983.14
64181448-418144894.99895.09
15min14217224-421722495.81195.791.1796.0796.031.18
24239207-423920796.31096.55
34234282-423428296.19896.44
44219996-421999695.87496.11
54121961-412196193.64793.87
64264663-426466396.88997.14
20min14223396-422339695.95196.250.5396.3796.650.54
24242711-424271196.39096.79
34248618-424861896.52496.92
44228225-422822596.06196.45
54206420-420642095.56595.94
64270328-427032897.01797.43
30min14243729-424372996.41396.870.6396.9997.430.64
24277337-427733797.17797.74
34276285-427628597.15397.71
44247182-424718296.49297.04
54233893-423389396.19096.73
64304314-430431497.79098.37
45min14242633-424263396.38896.890.6497.1397.610.64
24285412-428541297.36098.08
34274644-427464497.11597.84
44247870-424787096.50797.22
54234352-423435296.20096.90
64302568-430256897.75098.49
60min14229465-422946596.08996.890.6496.9997.780.64
24283357-428335797.31398.20
34281380-428138097.26898.15
44256064-425606496.69397.57
54239916-423991696.32697.19
64298531-429853197.65898.56
极限14224886-422488695.98596.710.5697.0497.760.56
24272579-427257997.06998.12
34269325-426932596.99598.04
44255741-425574196.68697.72
54234072-423407296.19497.21
64285409-428540997.36098.43
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