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101278-202104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500
标示量(mg)20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%
19.653817369382628138239953821901382558938230270.10
29.823884029388568038848540.04
单位质量响应值RSD%判断
396168.60395606.310.11数据可信
供试品溶液-20200709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%
5min134906-349060.7940.8013.000.790.8012.98
239062-390620.8880.89
338187-381870.8680.87
426743-267430.6080.61
537898-378980.8620.86
633980-339800.7720.77
10min140493-404930.9210.904.970.920.904.92
240694-406940.9250.93
341347-413470.9400.94
436356-363560.8270.83
540320-403200.9170.92
637802-378020.8590.86
15min142095-420950.9570.932.630.960.932.55
241197-411970.9370.94
341084-410840.9340.94
440478-404780.9200.92
540883-408830.9290.93
638889-388890.8840.89
20min141227-412270.9370.932.030.940.941.96
240344-403440.9170.92
342498-424980.9660.97
441274-412740.9380.94
541270-412700.9380.94
640182-401820.9130.92
30min141620-416200.9460.941.240.950.951.34
240677-406770.9250.93
341909-419090.9530.96
442003-420030.9550.96
541710-417100.9480.96
641089-410890.9340.94
45min135425-354250.8050.916.130.820.925.84
240723-407230.9260.94
340226-402260.9140.92
442691-426910.9710.98
540956-409560.9310.94
640605-406050.9230.93
60min141093-410930.9340.931.580.950.941.57
240144-401440.9130.92
341902-419020.9530.96
441161-411610.9360.95
540277-402770.9160.93
640767-407670.9270.94
90min140653-406530.9240.912.270.940.922.44
240635-406350.9240.94
339706-397060.9030.92
440285-402850.9160.93
538284-382840.8700.88
640358-403580.9170.93
120min140339-403390.9170.902.060.930.922.04
238420-384200.8730.89
340470-404700.9200.94
439572-395720.9000.92
538919-389190.8850.90
639924-399240.9080.92
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140728-407280.9260.911.590.940.921.50
239341-393410.8940.91
340306-403060.9160.93
440716-407160.9260.94
539352-393520.8950.91
639839-398390.9060.92
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101278-202104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500
标示量(mg)20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%
19.653874716387618838726043869143386831138721920.09
29.823936081393702139365510.02
单位质量响应值RSD%判断
401263.42400870.770.07数据可信
供试品溶液-20200709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%
5min137330-373300.8380.6824.560.840.6824.89
235826-358260.8040.80
335562-355620.7980.80
417984-179840.4040.40
528660-286600.6430.64
626416-264160.5930.59
10min137821-378210.8490.837.530.850.837.54
240663-406630.9120.91
339511-395110.8870.89
433063-330630.7420.74
535453-354530.7960.80
636061-360610.8090.81
15min137789-377890.8480.873.810.850.873.66
239807-398070.8930.90
341019-410190.9200.92
438543-385430.8650.87
537110-371100.8330.84
637704-377040.8460.85
20min139969-399690.8970.901.580.900.901.67
239344-393440.8830.89
340990-409900.9200.93
440325-403250.9050.91
539824-398240.8940.90
639345-393450.8830.89
30min139605-396050.8890.902.010.900.901.81
240343-403430.9050.91
339144-391440.8780.89
440847-408470.9170.92
539046-390460.8760.88
640721-407210.9140.92
45min137761-377610.8470.873.820.860.883.60
237975-379750.8520.86
340416-404160.9070.92
440819-408190.9160.92
537309-373090.8370.85
638364-383640.8610.87
60min139594-395940.8880.872.940.900.883.12
238765-387650.8700.88
338002-380020.8530.86
439005-390050.8750.89
536555-365550.8200.83
639449-394490.8850.90
90min138473-384730.8630.852.700.880.862.49
239229-392290.8800.89
337888-378880.8500.86
437353-373530.8380.85
536245-362450.8130.83
637551-375510.8430.86
120min139076-390760.8770.864.320.890.884.14
238864-388640.8720.89
340044-400440.8990.91
439646-396460.8900.90
536788-367880.8260.84
635915-359150.8060.82
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137410-374100.8390.862.410.860.882.48
238072-380720.8540.87
339638-396380.8890.91
438924-389240.8730.89
537194-371940.8350.85
637960-379600.8520.87
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101278-202104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500
标示量(mg)20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%
19.653896757389834538979243898513389625638975590.03
29.823881606388741038845080.11
单位质量响应值RSD%判断
403892.12395571.081.48数据可信
供试品溶液-20200710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%
5min142623-426230.9600.7018.970.960.7018.69
228699-286990.6460.65
330889-308890.6960.70
426915-269150.6060.61
526922-269220.6060.61
630660-306600.6900.69
10min138803-388030.8740.864.630.880.864.56
237512-375120.8450.85
340685-406850.9160.92
435289-352890.7950.80
538682-386820.8710.87
638195-381950.8600.86
15min139094-390940.8800.902.020.880.902.17
240711-407110.9170.92
340190-401900.9050.91
440443-404430.9110.91
539745-397450.8950.90
638661-386610.8710.87
20min140632-406320.9150.922.330.920.922.22
242011-420110.9460.95
340435-404350.9100.92
441517-415170.9350.94
539801-398010.8960.90
639606-396060.8920.90
30min140193-401930.9050.913.520.910.923.61
242110-421100.9480.96
340984-409840.9230.93
441087-410870.9250.93
540672-406720.9160.92
637889-378890.8530.86
45min138515-385150.8670.914.660.880.924.53
241396-413960.9320.94
343396-433960.9770.99
440813-408130.9190.93
539943-399430.8990.91
638475-384750.8660.88
60min140236-402360.9060.913.030.920.922.84
240888-408880.9210.93
342223-422230.9510.96
440299-402990.9070.92
538537-385370.8680.88
639811-398110.8960.91
90min139466-394660.8890.884.850.900.895.01
242310-423100.9530.97
336783-367830.8280.84
438143-381430.8590.87
538564-385640.8680.88
638175-381750.8600.87
120min139360-393600.8860.881.500.900.901.55
238941-389410.8770.89
339719-397190.8940.91
438342-383420.8630.88
539704-397040.8940.91
638532-385320.8680.88
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138581-385810.8690.891.810.890.911.81
240280-402800.9070.92
340386-403860.9090.93
439372-393720.8870.90
539753-397530.8950.91
638926-389260.8770.89
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101278-202104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500
标示量(mg)20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%
19.653866621386514638613733869823386542738656780.08
29.823892958389572538943420.06
单位质量响应值RSD%判断
400588.39396572.510.72数据可信
供试品溶液-20200710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%
5min130948-309480.6990.7210.550.700.7210.35
238572-385720.8710.87
331755-317550.7170.72
431440-314400.7100.71
530978-309780.7000.70
628625-286250.6460.65
10min138805-388050.8760.863.410.880.863.57
239820-398200.8990.90
338576-385760.8710.87
437602-376020.8490.85
536744-367440.8300.83
636427-364270.8230.82
15min138855-388550.8770.871.980.880.882.14
239089-390890.8830.89
338879-388790.8780.88
439120-391200.8830.89
537111-371110.8380.84
638390-383900.8670.87
20min138166-381660.8620.872.860.870.882.77
240062-400620.9050.91
337545-375450.8480.85
439375-393750.8890.89
539252-392520.8860.89
637350-373500.8430.85
30min138508-385080.8700.862.000.880.872.11
238448-384480.8680.88
339356-393560.8890.90
437313-373130.8430.85
537595-375950.8490.86
637678-376780.8510.86
45min139335-393350.8880.863.840.900.873.77
240003-400030.9030.91
337987-379870.8580.87
436570-365700.8260.84
537351-373510.8430.85
636469-364690.8230.83
60min139200-392000.8850.853.220.900.863.17
237772-377720.8530.86
337275-372750.8420.85
435673-356730.8060.82
538164-381640.8620.87
638579-385790.8710.88
90min140057-400570.9050.845.560.920.855.43
239428-394280.8900.90
336938-369380.8340.85
435897-358970.8110.82
535736-357360.8070.82
635127-351270.7930.81
120min137019-370190.8360.823.870.850.833.99
236577-365770.8260.84
338141-381410.8610.88
434308-343080.7750.79
536149-361490.8160.83
634918-349180.7880.80
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136893-368930.8330.811.800.850.821.83
235729-357290.8070.82
335970-359700.8120.83
435013-350130.7910.81
535764-357640.8080.82
635308-353080.7970.81
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