盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.312190812184472189482179532189212186700.22
216.352192052187062189560.17
单位质量响应值RSD%判断
13407.1113391.800.09数据可信
供试品溶液-2024042721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%
5min138515-3851519.22119.735.0219.2219.735.03
239266-3926619.59619.60
342030-4203020.97520.98
436353-3635318.14218.14
540235-4023520.08020.08
640832-4083220.37820.38
10min183562-8356241.70245.478.2041.8145.588.19
282703-8270341.27441.38
3102074-10207450.94151.06
492119-9211945.97346.07
589778-8977844.80444.92
696422-9642248.12048.23
15min1121454-12145460.61362.144.2860.9562.504.27
2121862-12186260.81661.15
3122535-12253561.15261.55
4123388-12338861.57861.93
5122594-12259461.18161.54
6135295-13529567.52067.90
20min1129545-12954564.65065.381.0865.3366.091.06
2133405-13340566.57767.25
3129988-12998864.87165.61
4130452-13045265.10365.80
5130869-13086965.31166.01
6131783-13178365.76766.52
30min1129525-12952564.64067.262.8965.6768.342.85
2134876-13487667.31168.36
3132871-13287166.31067.41
4141387-14138770.56071.62
5135488-13548867.61668.68
6134552-13455267.14968.27
45min1115387-11538757.58565.017.0858.9866.456.97
2123182-12318261.47562.89
3130791-13079165.27266.74
4137194-13719468.46869.92
5138015-13801568.87770.32
6136983-13698368.36269.86
极限1102634-10263451.22064.6515.0352.9366.4614.70
2107600-10760053.69955.46
3133884-13388466.81668.65
4144454-14445472.09173.92
5146259-14625972.99274.81
6142466-14246671.09972.97
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.312191112189632187842195172186002189950.16
216.352187472185702186580.06
单位质量响应值RSD%判断
13427.0413373.580.29数据可信
供试品溶液-2024042721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%
5min135986-3598617.95820.2410.5817.9620.2410.57
240566-4056620.24420.24
340972-4097220.44620.45
435581-3558117.75617.76
543628-4362821.77221.77
646614-4661423.26223.26
10min182647-8264741.24346.488.8241.3446.608.82
290001-9000144.91345.03
386186-8618643.00943.12
498920-9892049.36449.46
597015-9701548.41348.53
6104115-10411551.95652.09
15min1123183-12318361.47261.431.6561.8061.801.65
2125622-12562262.68963.05
3119596-11959659.68260.03
4123836-12383661.79862.17
5122408-12240861.08561.47
6123957-12395761.85862.28
20min1128726-12872664.23864.822.0264.9165.542.03
2131911-13191165.82766.54
3125278-12527862.51763.20
4130457-13045765.10265.82
5132492-13249266.11766.85
6130505-13050565.12665.89
30min1122992-12299261.37665.773.6662.4066.853.65
2132136-13213665.94067.02
3130447-13044765.09766.13
4133711-13371166.72567.80
5135010-13501067.37468.47
6136529-13652968.13269.26
45min1105648-10564852.72164.419.3754.0965.859.22
2126838-12683863.29664.74
3132649-13264966.19667.59
4136562-13656268.14869.60
5137060-13706068.39769.87
6135715-13571567.72669.23
极限196611-9661148.21264.2414.6049.8766.0414.31
2117123-11712358.44860.24
3131342-13134265.54367.30
4138697-13869769.21471.04
5146167-14616772.94174.79
6142454-14245471.08872.97
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