氨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%
114.796814246807496806306808336802976807870.07
214.846798536795596797060.04
单位质量响应值RSD%判断
46030.2245802.290.36数据可信
供试品溶液-H043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%
5min1220040-22004027.80827.536.9127.8127.536.91
2214417-21441727.09827.10
3229645-22964529.02229.02
4237655-23765530.03430.03
5210218-21021826.56726.57
6194922-19492224.63424.63
10min1561123-56112370.91470.291.5370.9670.341.53
2554366-55436670.06070.10
3555278-55527870.17570.22
4568206-56820671.80971.86
5555648-55564870.22270.27
6542606-54260668.57368.61
15min1785567-78556799.27897.901.1599.4498.061.15
2765447-76544796.73696.90
3764588-76458896.62796.79
4783617-78361799.03299.20
5776140-77614098.08798.25
6772694-77269497.65197.81
20min1805969-805969101.857102.180.30102.19102.510.31
2808428-808428102.167102.49
3810423-810423102.420102.75
4811932-811932102.610102.95
5808772-808772102.211102.54
6805764-805764101.831102.15
30min1803893-803893101.594101.950.37102.09102.450.38
2806434-806434101.915102.41
3809493-809493102.302102.80
4811071-811071102.501103.01
5805674-805674101.819102.31
6803779-803779101.580102.07
45min1801224-801224101.257101.750.35101.93102.420.35
2804835-804835101.713102.38
3807252-807252102.019102.69
4809195-809195102.264102.94
5803568-803568101.553102.22
6804539-804539101.676102.33
极限1800089-800089101.114101.560.32101.95102.400.32
2801582-801582101.302102.14
3805695-805695101.822102.66
4806865-806865101.970102.82
5804446-804446101.664102.50
6803173-803173101.503102.33
氨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%
114.796799486803626799496797036799446799810.04
214.846808786813266811020.05
单位质量响应值RSD%判断
45975.7345896.360.13数据可信
供试品溶液-H043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%
5min1233693-23369329.52127.228.0129.5227.228.01
2229105-22910528.94128.94
3191106-19110624.14124.14
4209157-20915726.42126.42
5227739-22773928.76928.77
6201883-20188325.50225.50
10min1568666-56866671.83570.533.5371.8870.573.53
2576731-57673172.85472.90
3523447-52344766.12366.16
4569650-56965071.96072.00
5563679-56367971.20571.25
6547630-54763069.17869.22
15min1802285-802285101.34798.262.22101.5298.422.23
2792404-792404100.099100.27
3756971-75697195.62395.77
4778208-77820898.30598.47
5774557-77455797.84498.01
6762536-76253696.32696.48
20min1833749-833749105.321102.441.56105.66102.761.56
2809909-809909102.310102.65
3801968-801968101.307101.62
4816216-816216103.107103.43
5801121-801121101.200101.53
6802517-802517101.376101.69
30min1832454-832454105.158102.241.61105.67102.741.61
2808901-808901102.183102.69
3801182-801182101.207101.69
4815193-815193102.977103.48
5797527-797527100.746101.24
6801112-801112101.199101.69
45min1833338-833338105.270102.191.76105.96102.861.76
2815530-815530103.020103.70
3797442-797442100.735101.38
4810869-810869102.431103.10
5797356-797356100.724101.39
6799191-799191100.956101.61
极限1832664-832664105.184101.721.83106.05102.561.83
2804471-804471101.623102.47
3791949-791949100.041100.86
4808496-808496102.131102.97
5797823-797823100.783101.62
6795927-795927100.544101.37
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