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对照品来源中检所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%
110.972643532645402648532642362644292644820.09
211.172727722732332730020.12
单位质量响应值RSD%判断
24109.5724440.640.97数据可信
供试品溶液-3788B批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11815-18150.6720.6418.100.670.6417.93
22132-21320.7900.79
31804-18040.6680.67
41652-16520.6120.61
51720-17200.6370.64
61179-11790.4370.44
10min13585-35851.3281.236.271.331.236.23
23241-32411.2001.20
33233-32331.1971.20
43519-35191.3031.30
53259-32591.2071.21
63023-30231.1201.12
15min14624-46241.7131.596.931.721.596.99
24292-42921.5901.59
34289-42891.5891.59
44608-46081.7071.71
54049-40491.5001.50
63878-38781.4361.44
20min14389-43891.6261.663.551.631.673.56
24345-43451.6091.62
34781-47811.7711.78
44405-44051.6321.64
54541-45411.6821.69
64468-44681.6551.66
30min14938-49381.8291.773.471.841.783.44
24843-48431.7941.80
34853-48531.7981.81
44929-49291.8261.83
54555-45551.6871.70
64606-46061.7061.71
45min14596-45961.7021.743.071.711.753.01
24920-49201.8221.83
34503-45031.6681.68
44779-47791.7701.78
54702-47021.7421.75
64696-46961.7391.75
60min15066-50661.8761.824.151.891.834.25
24983-49831.8461.86
35025-50251.8611.88
44912-49121.8191.83
54973-49731.8421.86
64509-45091.6701.68
90min14616-46161.7101.742.101.731.752.13
24831-48311.7891.81
34699-46991.7401.76
44572-45721.6931.71
54630-46301.7151.73
64765-47651.7651.78
120min14541-45411.6821.755.711.701.775.62
24798-47981.7771.80
35026-50261.8621.88
45027-50271.8621.88
54536-45361.6801.70
64402-44021.6301.65
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14209-42091.5591.745.731.581.765.66
24736-47361.7541.78
34909-49091.8181.84
44965-49651.8391.86
54629-46291.7151.74
64705-47051.7431.76
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对照品来源中检所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%
110.975359285358325359425353635349485356030.09
211.175461835460075460950.03
单位质量响应值RSD%判断
48824.3448889.440.10数据可信
供试品溶液-4229B批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12316-23160.4260.4123.450.430.4123.09
22876-28760.5290.53
31282-12820.2360.24
42294-22940.4220.42
52388-23880.4390.44
62164-21640.3980.40
10min13808-38080.7010.706.070.700.706.14
23630-36300.6680.67
33761-37610.6920.69
44223-42230.7770.78
53643-36430.6700.67
63627-36270.6670.67
15min14464-44640.8210.837.210.820.837.12
24113-41130.7570.76
34492-44920.8270.83
44650-46500.8560.86
55045-50450.9280.93
64258-42580.7840.79
20min14365-43650.8030.835.220.810.845.33
24288-42880.7890.79
34822-48220.8870.89
44803-48030.8840.89
54542-45420.8360.84
64347-43470.8000.80
30min14270-42700.7860.836.470.790.836.74
24174-41740.7680.77
34842-48420.8910.90
44678-46780.8610.87
54730-47300.8700.88
64252-42520.7820.79
45min14133-41330.7610.869.060.770.868.94
24745-47450.8730.88
35392-53920.9921.00
44406-44060.8110.82
54580-45800.8430.85
64645-46450.8550.86
60min14165-41650.7660.889.070.770.899.21
24584-45840.8440.85
35319-53190.9790.99
44610-46100.8480.86
54891-48910.9000.91
65221-52210.9610.97
90min14556-45560.8380.817.900.850.828.06
23869-38690.7120.72
34447-44470.8180.83
44936-49360.9080.92
54320-43200.7950.80
64318-43180.7950.80
120min13926-39260.7220.786.670.730.796.54
24107-41070.7560.77
34677-46770.8610.87
44086-40860.7520.76
54469-44690.8220.83
64125-41250.7590.77
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14432-44320.8160.845.080.830.855.07
24364-43640.8030.81
34923-49230.9060.92
44571-45710.8410.85
54775-47750.8790.89
64368-43680.8040.82
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