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%
110.554084881408479940843414082471408281440838610.03
210.724198365420018841992760.04
单位质量响应值RSD%判断
387095.83391723.510.85数据可信
供试品溶液-250601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%
5min110680-106800.2470.2435.950.250.2436.96
215942-159420.3680.37
310588-105880.2440.24
411295-112950.2610.26
54104-41040.0950.09
610304-103040.2380.24
10min132552-325520.7520.777.960.750.787.86
238097-380970.8800.88
335069-350690.8100.81
432055-320550.7400.74
530574-305740.7060.71
632911-329110.7600.76
15min142215-422150.9750.961.610.980.961.67
241381-413810.9550.96
341579-415790.9600.96
442477-424770.9810.98
540776-407760.9420.94
641012-410120.9470.95
20min143210-432100.9980.991.021.000.991.00
241934-419340.9680.97
342812-428120.9890.99
442613-426130.9840.99
542895-428950.9900.99
642786-427860.9880.99
30min142143-421430.9730.991.160.981.001.04
243010-430100.9931.00
343002-430020.9931.00
442934-429340.9911.00
543671-436711.0081.01
642646-426460.9850.99
45min141184-411840.9510.964.840.960.974.67
242735-427350.9870.99
342813-428130.9891.00
441732-417320.9640.97
543737-437371.0101.02
638047-380470.8780.89
60min142181-421810.9740.973.840.980.983.65
241792-417920.9650.97
342512-425120.9820.99
441535-415350.9590.97
544456-444561.0261.03
639438-394380.9110.92
90min142455-424550.9800.954.380.990.964.17
239394-393940.9100.92
341918-419180.9680.98
438808-388080.8960.91
543419-434191.0031.01
640697-406970.9400.95
120min141941-419410.9680.924.900.980.944.76
238770-387700.8950.91
341697-416970.9630.97
438107-381070.8800.89
541759-417590.9640.98
637889-378890.8750.89
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138759-387590.8950.922.930.910.932.73
241071-410710.9480.96
340045-400450.9250.94
440075-400750.9250.94
540133-401330.9270.94
637809-378090.8730.89
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%
110.554160629416618441680794163835416663541650720.07
210.724152919415633341546260.06
单位质量响应值RSD%判断
394793.55387558.401.31数据可信
供试品溶液-250601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%
5min111900-119000.2740.2131.790.270.2132.44
29338-93380.2150.21
36204-62040.1430.14
47809-78090.1800.18
56943-69430.1600.16
613787-137870.3170.32
10min136223-362230.8330.7312.250.830.7312.29
226274-262740.6040.60
330152-301520.6930.69
432362-323620.7440.74
529823-298230.6860.69
636152-361520.8310.83
15min142750-427500.9830.933.160.980.933.15
238858-388580.8930.89
340496-404960.9310.93
440339-403390.9270.93
539961-399610.9190.92
640638-406380.9340.94
20min141641-416410.9570.962.410.960.962.32
240930-409300.9410.94
343518-435181.0001.00
441880-418800.9630.97
541791-417910.9610.96
640640-406400.9340.94
30min142363-423630.9740.973.170.980.983.20
242583-425830.9790.98
343968-439681.0111.02
443145-431450.9921.00
541384-413840.9510.96
640191-401910.9240.93
45min142409-424090.9750.963.450.980.963.45
241267-412670.9490.95
343265-432650.9951.00
442645-426450.9800.99
540267-402670.9260.93
639644-396440.9110.92
60min140095-400950.9220.934.670.930.944.73
241304-413040.9490.96
342860-428600.9850.99
441001-410010.9420.95
541258-412580.9480.96
637204-372040.8550.86
90min140961-409610.9420.933.250.950.943.44
240092-400920.9220.93
342437-424370.9750.99
440269-402690.9260.94
540404-404040.9290.94
638367-383670.8820.89
120min140407-404070.9290.934.400.940.944.52
237920-379200.8720.88
341665-416650.9580.97
441163-411630.9460.96
542285-422850.9720.98
638423-384230.8830.89
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139773-397730.9140.924.130.930.933.93
239607-396070.9100.92
342233-422330.9710.98
441695-416950.9580.97
538565-385650.8860.90
638173-381730.8770.89
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