非布司他多替诺雷片项目信息
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%
111.135435285435505437225433545430145434340.05
211.155544215540175542190.06
单位质量响应值RSD%判断
48826.0649705.741.27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%
5min12522-25220.4600.3634.670.460.3634.93
22257-22570.4120.41
32174-21740.3970.40
42098-20980.3830.38
52302-23020.4200.42
6615-6150.1120.11
10min14153-41530.7580.6149.090.760.6149.11
23941-39410.7190.72
33857-38570.7040.70
44061-40610.7410.74
53938-39380.7190.72
6-0.0000.00
15min14456-44560.8130.792.790.820.803.05
24348-43480.7940.80
34513-45130.8240.83
44278-42780.7810.78
54198-41980.7660.77
64270-42700.7790.78
20min14474-44740.8170.834.040.820.834.14
24778-47780.8720.88
34621-46210.8430.85
44483-44830.8180.82
54254-42540.7760.78
64661-46610.8510.85
30min14534-45340.8280.832.480.830.842.25
24506-45060.8220.83
34587-45870.8370.84
44451-44510.8120.82
54464-44640.8150.82
64754-47540.8680.87
45min14493-44930.8200.833.300.830.843.14
24713-47130.8600.87
34327-43270.7900.80
44737-47370.8650.87
54587-45870.8370.84
64585-45850.8370.84
60min14412-44120.8050.811.240.810.821.34
24436-44360.8100.82
34462-44620.8140.82
44414-44140.8060.81
54557-45570.8320.84
64485-44850.8190.82
90min14375-43750.7980.794.490.810.804.57
23968-39680.7240.73
34351-43510.7940.80
44514-45140.8240.83
54428-44280.8080.82
64450-44500.8120.82
120min14574-45740.8350.833.570.840.843.16
24495-44950.8200.83
34611-46110.8420.85
44540-45400.8290.84
54361-43610.7960.81
64852-48520.8860.89
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14201-42010.7670.815.820.780.825.68
24355-43550.7950.81
34255-42550.7770.79
44831-48310.8820.89
54288-42880.7830.79
64685-46850.8550.87
非布司他多替诺雷片项目信息
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%
111.132714772713172715562717742709702714190.12
211.152775602773012774300.07
单位质量响应值RSD%判断
24386.2524881.611.43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%
5min11704-17040.6220.4243.360.620.4243.46
2929-9290.3390.34
3360-3600.1310.13
4991-9910.3620.36
51341-13410.4890.49
61611-16110.5880.59
10min13352-33521.2241.2111.431.221.2111.44
23435-34351.2541.25
32705-27050.9870.99
43234-32341.1801.18
53879-38791.4161.42
63267-32671.1931.19
15min14247-42471.5501.447.181.551.457.28
23876-38761.4151.42
33433-34331.2531.25
44097-40971.4951.50
54021-40211.4681.47
64078-40781.4891.49
20min14034-40341.4721.543.991.481.553.93
24051-40511.4791.48
34412-44121.6101.61
44418-44181.6131.62
54190-41901.5291.54
64269-42691.5581.56
30min14444-44441.6221.632.711.631.642.72
24576-45761.6701.68
34304-43041.5711.58
44434-44341.6191.63
54398-43981.6051.61
64635-46351.6921.70
45min14550-45501.6611.652.861.671.663.03
24699-46991.7151.73
34342-43421.5851.59
44434-44341.6191.63
54437-44371.6201.63
64594-45941.6771.69
60min14617-46171.6851.632.271.701.642.37
24360-43601.5911.60
34471-44711.6321.64
44451-44511.6251.64
54558-45581.6641.68
64371-43711.5961.61
90min14588-45881.6751.645.301.691.665.26
24810-48101.7561.77
34401-44011.6061.62
44697-46971.7151.73
54295-42951.5681.58
64203-42031.5341.55
120min14442-44421.6211.614.231.641.634.14
24404-44041.6081.63
34337-43371.5831.60
44202-42021.5341.55
54751-47511.7341.75
64321-43211.5771.60
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14519-45191.6501.666.441.671.686.36
24733-47331.7281.75
34490-44901.6391.66
44841-48411.7671.79
54694-46941.7131.74
64015-40151.4661.49
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