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101278-202405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%
110.554068023406192140647664056733405215040607190.16
210.724177454417322141753380.08
单位质量响应值RSD%判断
384902.27389490.490.84数据可信
供试品溶液-250602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%
5min122984-229840.5340.629.770.530.6210.15
228811-288110.6690.67
324552-245520.5700.57
427247-272470.6330.63
529964-299640.6960.70
626399-263990.6130.61
10min145043-450431.0460.936.741.050.936.84
240413-404130.9380.94
337386-373860.8680.87
439778-397780.9240.92
538287-382870.8890.89
639112-391120.9080.91
15min140866-408660.9490.972.550.950.972.66
243648-436481.0141.02
340691-406910.9450.95
441707-417070.9690.97
541707-417070.9690.97
642089-420890.9770.98
20min140974-409740.9511.017.510.961.027.57
243683-436831.0141.02
342798-427980.9941.00
442063-420630.9770.98
541985-419850.9750.98
650007-500071.1611.17
30min140546-405460.9420.962.290.950.972.26
241536-415360.9650.97
341923-419230.9740.98
441769-417690.9700.98
540276-402760.9350.94
642860-428600.9951.00
45min139086-390860.9080.952.720.920.962.68
241824-418240.9710.98
340877-408770.9490.96
440805-408050.9480.96
540157-401570.9330.94
642161-421610.9790.99
60min139943-399430.9280.942.350.940.952.07
241459-414590.9630.97
341444-414440.9620.97
441145-411450.9550.96
539056-390560.9070.92
640779-407790.9470.96
90min140290-402900.9360.931.590.950.941.74
240011-400110.9290.94
340313-403130.9360.95
440168-401680.9330.94
539233-392330.9110.92
641224-412240.9570.97
120min138057-380570.8840.911.680.900.921.64
238783-387830.9010.91
339491-394910.9170.93
439914-399140.9270.94
539363-393630.9140.93
639486-394860.9170.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限137585-375850.8730.912.450.890.932.23
239259-392590.9120.93
340322-403220.9360.95
439598-395980.9200.93
540036-400360.9300.94
639097-390970.9080.92
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101278-202405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%
110.554094164409916840982004101520410145640989020.08
210.724121320412068841210040.02
单位质量响应值RSD%判断
388521.52384422.010.76数据可信
供试品溶液-250602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%
5min129521-295210.6870.6716.860.690.6817.08
224877-248770.5790.58
338071-380710.8860.89
428632-286320.6660.67
524614-246140.5730.57
628241-282410.6570.66
10min139096-390960.9100.901.960.910.901.99
238472-384720.8950.90
338206-382060.8890.89
438938-389380.9060.91
537344-373440.8690.87
639440-394400.9180.92
15min140637-406370.9450.961.780.950.961.80
241510-415100.9660.97
341265-412650.9600.96
440003-400030.9310.93
542115-421150.9800.98
641021-410210.9540.96
20min141152-411520.9570.962.310.960.962.23
240779-407790.9490.95
341716-417160.9710.98
442490-424900.9890.99
539689-396890.9230.93
641114-411140.9570.96
30min140727-407270.9480.951.990.950.952.00
239482-394820.9190.92
340057-400570.9320.94
441513-415130.9660.97
540748-407480.9480.95
641551-415510.9670.97
45min140626-406260.9451.0115.880.951.0215.80
239717-397170.9240.93
340957-409570.9530.96
441957-419570.9760.98
557311-573111.3331.34
639571-395710.9210.93
60min140425-404250.9400.922.710.950.932.85
237618-376180.8750.88
340360-403600.9390.95
440224-402240.9360.94
539473-394730.9180.93
639241-392410.9130.92
90min139315-393150.9150.902.050.930.911.94
238267-382670.8900.90
338128-381280.8870.90
439232-392320.9130.92
538649-386490.8990.91
637242-372420.8660.88
120min137972-379720.8830.9516.130.900.9715.92
238209-382090.8890.90
354461-544611.2671.28
438696-386960.9000.91
538815-388150.9030.92
637819-378190.8800.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限138287-382870.8910.892.480.900.902.60
237028-370280.8610.87
339267-392670.9140.93
439326-393260.9150.93
538673-386730.9000.91
637481-374810.8720.89
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