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DSZJ-4057-240226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(%)100.0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%
116.222129612127822135992133092134752132250.17
216.25 2135812131912133860.13
单位质量响应值RSD%判断
13145.8113131.450.08数据可信
供试品溶液-2024042521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%
5min136728-3672818.73119.7726.0618.7319.7726.06
252909-5290926.98326.98
339690-3969020.24120.24
435604-3560418.15818.16
522733-2273311.59311.59
644915-4491522.90622.91
10min1105651-10565153.88051.428.5853.9851.538.60
2106466-10646654.29654.45
3111342-11134256.78356.90
492668-9266847.25947.36
588950-8895045.36345.43
699905-9990550.95051.08
15min1126619-12661964.57461.326.0964.9861.726.09
2117566-11756659.95760.41
3130869-13086966.74167.17
4119913-11991361.15461.52
5111082-11108256.65056.97
6115425-11542558.86559.28
20min1127958-12795865.25763.773.3766.0264.513.41
2123120-12312062.78963.57
3129892-12989266.24367.04
4126723-12672364.62765.33
5117974-11797460.16560.80
6124594-12459463.54164.28
30min1138315-13831570.53966.655.5171.6667.745.49
2124302-12430263.39264.53
3138734-13873470.75271.92
4127637-12763765.09366.16
5121821-12182162.12763.09
6133274-13327467.96869.06
45min1133873-13387368.27367.814.9869.7969.284.97
2128339-12833965.45166.94
3142531-14253172.68974.25
4137210-13721069.97571.40
5123640-12364063.05564.37
6132242-13224267.44168.91
60min1132802-13280267.72766.604.9169.6268.444.88
2122611-12261162.53064.38
3140384-14038471.59473.56
4130627-13062766.61868.43
5124559-12455963.52365.18
6132578-13257867.61369.46
极限1127911-12791165.23365.284.8467.5067.494.79
2118912-11891260.64362.84
3137881-13788170.31772.68
4129797-12979766.19568.38
5125142-12514263.82165.83
6128405-12840565.48567.70
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DSZJ-4057-240226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(%)100.0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%
116.222140152147422145222145912148712145480.16
216.25 2138082136692137380.05
单位质量响应值RSD%判断
13227.3713153.110.40数据可信
供试品溶液-2024042521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%
5min140218-4021820.43020.209.5620.4320.209.54
244616-4461622.66522.66
333497-3349717.01617.02
437986-3798619.29719.30
540131-4013120.38620.39
642186-4218621.43021.43
10min1108697-10869755.21753.726.4855.3353.836.47
2100178-10017850.89051.02
398956-9895650.26950.36
4111503-11150356.64356.75
5114949-11494958.39358.51
6100181-10018150.89151.01
15min1128344-12834465.19864.633.0065.6265.042.99
2128635-12863565.34665.75
3129330-12933065.69966.07
4128149-12814965.09965.52
5129409-12940965.73966.18
6119533-11953360.72261.12
20min1140228-14022871.23568.643.7072.0269.413.70
2133756-13375667.94768.72
3132311-13231167.21367.95
4135654-13565468.91169.69
5141000-14100071.62772.43
6127769-12776964.90665.64
30min1139635-13963570.93469.981.7572.1171.131.76
2136596-13659669.39070.54
3138696-13869670.45771.57
4137843-13784370.02371.19
5140140-14014071.19072.39
6133578-13357867.85768.96
45min1144100-14410073.20271.202.8774.7772.742.84
2139993-13999371.11572.65
3143991-14399173.14674.65
4140942-14094271.59873.15
5138690-13869070.45472.05
6133246-13324667.68869.16
60min1137551-13755169.87569.673.8671.8571.613.78
2132455-13245567.28669.22
3144446-14444673.37875.29
4134800-13480068.47770.43
5142230-14223072.25274.24
6131435-13143566.76868.62
极限1134539-13453968.34566.541.4670.7168.861.43
2130413-13041366.24968.55
3131478-13147866.79069.11
4130281-13028166.18268.52
5129078-12907865.57167.96
6130084-13008466.08268.31
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DSZJ-4057-240226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(%)100.0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%
116.222138432142572142742141792144382141980.11
216.25 2154402154242154320.01
单位质量响应值RSD%判断
13205.8013257.350.28数据可信
供试品溶液-2024042621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%
5min133761-3376117.09724.7619.1917.1024.7619.18
241381-4138120.95620.96
358593-5859329.67229.67
451641-5164126.15126.15
553197-5319726.93926.94
654734-5473427.71827.72
10min197838-9783849.54652.378.0049.6452.518.00
2104226-10422652.78052.90
3106487-10648753.92554.09
493709-9370947.45547.60
5100758-10075851.02451.17
6117533-11753359.51959.67
15min1119084-11908460.30562.314.6460.6762.744.64
2124922-12492263.26163.67
3118347-11834759.93160.40
4116898-11689859.19859.61
5129574-12957465.61766.05
6129433-12943365.54566.03
20min1130348-13034866.00966.572.7866.7167.342.80
2131131-13113166.40567.17
3131876-13187666.78367.58
4125500-12550063.55464.29
5136591-13659169.17069.97
6133252-13325267.47968.33
30min1133565-13356567.63868.344.1368.7169.494.11
2137134-13713469.44570.58
3129274-12927465.46566.63
4128185-12818564.91366.00
5141811-14181171.81473.00
6139755-13975570.77372.00
45min1130901-13090166.28967.964.5667.7469.484.54
2133941-13394167.82869.34
3127674-12767464.65566.19
4130120-13012065.89367.34
5138417-13841770.09571.68
6144164-14416473.00574.62
60min1128137-12813764.88967.404.4066.7169.304.34
2129640-12964065.65067.54
3125951-12595163.78265.67
4137506-13750669.63471.45
5137489-13748969.62571.60
6139793-13979370.79272.81
极限1126688-12668864.15563.645.1966.3365.925.02
2121302-12130261.42863.69
3117218-11721859.36061.61
4134826-13482668.27670.48
5122918-12291862.24664.60
6131098-13109866.38968.80
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DSZJ-4057-240226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(%)100.0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%
116.222131382132752132772132562133272132550.04
216.25 2155452158842157140.12
单位质量响应值RSD%判断
13147.6613274.710.69数据可信
供试品溶液-2024042621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%
5min151657-5165726.20027.6715.2626.2027.6715.27
268576-6857634.78134.78
348881-4888124.79224.79
445354-4535423.00323.00
553458-5345827.11427.11
659376-5937630.11530.12
10min1102299-10229951.88656.016.5852.0356.166.54
2109672-10967255.62555.82
3111204-11120456.40256.54
4116178-11617858.92559.05
5120563-12056361.14961.30
6102662-10266252.07052.24
15min1125539-12553963.67362.935.9664.1163.405.92
2119754-11975460.73961.24
3128307-12830765.07765.53
4127937-12793764.88965.34
5131613-13161366.75467.24
6111321-11132156.46256.92
20min1121233-12123361.48965.615.3162.2866.425.28
2126323-12632364.07064.91
3131904-13190466.90167.71
4135516-13551668.73369.55
5138096-13809670.04270.90
6123088-12308862.43063.20
30min1125848-12584863.83067.395.9564.9668.575.91
2129433-12943365.64866.84
3134845-13484568.39369.58
4139770-13977070.89172.09
5143591-14359172.82974.08
6123676-12367662.72863.85
45min1133495-13349567.70866.834.1769.1968.384.14
2124796-12479663.29664.86
3134811-13481168.37669.94
4135521-13552168.73670.33
5137076-13707669.52471.18
6124871-12487163.33464.80
60min1121654-12165461.70262.692.0263.5664.622.05
2122488-12248862.12564.04
3125859-12585963.83565.78
4121893-12189361.82463.80
5127589-12758964.71366.75
6122162-12216261.96063.78
极限1117613-11761359.65358.333.0361.8660.612.93
2116611-11661159.14561.40
3108658-10865855.11157.41
4117824-11782459.76062.08
5115868-11586858.76861.17
6113480-11348057.55759.72
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