氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04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0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.796742966736536738576735666741336739010.05
214.846735676733356734510.03
单位质量响应值RSD%判断
45564.6445380.800.29数据可信
供试品溶液-H043批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186353-18635323.78124.018.1323.7824.018.12
2159669-15966920.37520.38
3199577-19957725.46825.47
4201991-20199125.77625.78
5193669-19366924.71424.71
6187705-18770523.95323.95
10min1401319-40131951.21253.194.1451.2553.234.14
2404837-40483751.66151.70
3449080-44908057.30757.35
4420870-42087053.70753.75
5411121-41112152.46352.50
6413787-41378752.80352.84
15min1562160-56216071.73773.992.4971.8674.122.49
2576222-57622273.53273.65
3605092-60509277.21677.35
4585237-58523774.68274.81
5575919-57591973.49373.62
6574466-57446673.30873.44
20min1682327-68232787.07288.841.4287.3289.101.42
2701569-70156989.52789.77
3711362-71136290.77791.04
4697381-69738188.99389.25
5690986-69098688.17788.43
6693605-69360588.51188.76
30min1796458-796458101.636101.780.36102.03102.180.35
2801165-801165102.237102.63
3794201-794201101.348101.77
4800886-800886102.201102.61
5795908-795908101.566101.96
6796774-796774101.677102.07
45min1797416-797416101.758101.810.40102.32102.380.39
2801178-801178102.239102.80
3794050-794050101.329101.92
4800593-800593102.164102.74
5799614-799614102.039102.61
6794168-794168101.344101.91
极限1794833-794833101.429101.620.46102.16102.360.45
2800766-800766102.186102.92
3792622-792622101.147101.90
4800786-800786102.189102.93
5795813-795813101.554102.29
6793377-793377101.243101.98
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04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0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.796753536751036756746754676749766753150.05
214.846742046743206742620.02
单位质量响应值RSD%判断
45660.2445435.440.35数据可信
供试品溶液-H043批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228339-22833929.09022.6532.5029.0922.6532.50
2208736-20873626.59326.59
3108724-10872413.85113.85
499441-9944112.66912.67
5217809-21780927.74927.75
6203512-20351225.92725.93
10min1449218-44921857.23051.878.0957.2851.908.11
2422363-42236353.80953.85
3364470-36447046.43346.46
4372835-37283547.49947.52
5427658-42765854.48454.53
6406140-40614051.74251.79
15min1607588-60758877.40774.312.4077.5574.442.41
2574663-57466373.21273.35
3577240-57724073.54073.64
4574270-57427073.16273.26
5592811-59281175.52475.66
6573258-57325873.03373.16
20min1714003-71400390.96489.651.0691.2489.901.07
2695696-69569688.63288.89
3706246-70624689.97690.20
4703681-70368189.64989.87
5707876-70787690.18390.45
6694559-69455988.48788.74
30min1805610-805610102.635101.450.83103.06101.850.83
2791759-791759100.870101.27
3802801-802801102.277102.65
4793155-793155101.048101.42
5795774-795774101.382101.79
6788806-788806100.494100.89
45min1803020-803020102.305101.380.80102.90101.940.80
2794313-794313101.196101.77
3802885-802885102.288102.83
4791338-791338100.817101.36
5795528-795528101.350101.93
6787235-787235100.294100.86
极限1801368-801368102.094101.080.71102.86101.820.71
2792199-792199100.926101.67
3797507-797507101.602102.32
4790783-790783100.746101.45
5793298-793298101.066101.82
6785212-785212100.036100.77
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