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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.182113062111722112102112092109822111760.06
216.222110112114052112080.14
单位质量响应值RSD%判断
13051.6713021.450.17数据可信
供试品溶液-18016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%
5min131028-3102815.92514.1126.6715.9314.1126.67
220346-2034610.44310.44
340100-4010020.58220.58
426097-2609713.39513.39
526469-2646913.58513.59
620923-2092310.73910.74
10min1114156-11415658.59252.849.5358.6852.929.52
295126-9512648.82448.88
3102304-10230452.50852.62
488461-8846145.40345.48
5111483-11148357.22057.30
6106229-10622954.52354.58
15min1137670-13767070.66068.483.0471.0768.853.06
2129626-12962666.53266.86
3130210-13021066.83167.24
4129831-12983166.63766.96
5138323-13832370.99571.39
6134894-13489469.23669.60
20min1145311-14531174.58274.472.7975.3975.222.80
2140298-14029872.00972.71
3142878-14287873.33374.11
4142616-14261673.19973.90
5151311-15131177.66278.45
6148092-14809276.01076.76
30min1143543-14354373.67574.851.8874.9076.011.88
2143239-14323973.51974.62
3145462-14546274.66075.84
4144530-14453074.18175.28
5150139-15013977.06078.28
6148063-14806375.99577.16
45min1147472-14747275.69175.342.4577.3276.922.47
2142940-14294073.36574.87
3147811-14781175.86577.46
4142295-14229573.03474.55
5151823-15182377.92479.57
6148402-14840276.16977.76
60min1150757-15075777.37776.491.4979.4378.491.53
2146045-14604574.95976.87
3147883-14788375.90277.92
4147593-14759375.75377.67
5151889-15188977.95880.04
6150052-15005277.01579.03
极限1156560-15656080.35679.761.6182.8482.181.62
2153344-15334478.70581.04
3152526-15252678.28580.73
4154290-15429079.19181.53
5159253-15925381.73884.25
6156415-15641580.28182.72
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.182111682111742112242109612105922110240.13
216.222115582114172114880.05
单位质量响应值RSD%判断
13042.2713038.720.02数据可信
供试品溶液-18016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%
5min130797-3079715.80216.2324.6015.8016.2324.60
224991-2499112.82312.82
341190-4119021.13521.13
420849-2084910.69810.70
533523-3352317.20117.20
638469-3846919.73919.74
10min1100968-10096851.80750.277.5651.8950.367.57
285050-8505043.63943.71
3107244-10724455.02755.14
4101009-10100951.82851.89
596417-9641749.47249.57
697186-9718649.86649.98
15min1133497-13349768.49867.542.7368.8767.902.76
2127873-12787365.61265.93
3137675-13767570.64171.06
4129382-12938266.38666.73
5131956-13195667.70768.08
6129364-12936466.37766.76
20min1141424-14142472.56572.592.3973.3273.342.41
2140541-14054172.11272.79
3147838-14783875.85676.67
4138922-13892271.28172.00
5141715-14171572.71473.46
6138442-13844271.03571.79
30min1144768-14476874.28174.422.7475.4475.572.75
2144014-14401473.89474.97
3152273-15227378.13279.37
4141392-14139272.54973.66
5146060-14606074.94476.09
6141748-14174872.73173.88
45min1146920-14692075.38575.062.4576.9676.622.47
2145827-14582774.82476.31
3152333-15233378.16379.83
4141794-14179472.75574.27
5147039-14703975.44677.01
6143818-14381873.79375.35
60min1150175-15017577.05576.361.5779.0578.341.61
2147660-14766075.76577.67
3152854-15285478.43080.54
4147063-14706375.45877.38
5148494-14849476.19378.18
6146721-14672175.28377.25
极限1153388-15338878.70479.511.7381.1281.921.75
2155254-15525479.66181.99
3159758-15975881.97284.51
4151825-15182577.90280.24
5154984-15498479.52381.93
6154592-15459279.32281.70
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.182112412110602112372109192109952110900.07
216.222122812124982123900.08
单位质量响应值RSD%判断
13046.3513094.330.26数据可信
供试品溶液-2022060602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%
5min18378-83784.28913.2736.734.2913.2736.73
237085-3708518.98518.99
325604-2560413.10813.11
430008-3000815.36215.36
526784-2678413.71213.71
627643-2764314.15114.15
10min156371-5637128.85838.0613.2328.8838.1313.27
280512-8051241.21741.32
384005-8400543.00543.08
478975-7897540.43040.52
571657-7165736.68436.76
674521-7452138.15038.23
15min1104431-10443153.46258.024.0253.6558.314.08
2115954-11595459.36159.70
3116675-11667559.73060.04
4112933-11293357.81458.12
5114612-11461258.67458.95
6115444-11544459.10059.39
20min1121171-12117162.03165.262.7762.5165.872.82
2127154-12715465.09465.76
3129939-12993966.52067.16
4126549-12654964.78565.42
5131080-13108067.10467.71
6129004-12900466.04166.66
30min1129440-12944066.26568.582.5967.0969.552.62
2134143-13414368.67269.70
3137462-13746270.37171.38
4130010-13001066.55667.55
5136601-13660169.93170.91
6136098-13609869.67370.66
45min1136404-13640469.83070.922.5771.0272.272.57
2137973-13797370.63372.04
3142783-14278373.09574.50
4132901-13290168.03669.40
5140068-14006871.70573.07
6141047-14104772.20773.58
60min1140151-14015171.74872.951.5873.3374.701.62
2141587-14158772.48374.28
3145840-14584074.66076.47
4140296-14029671.82273.56
5143128-14312873.27275.04
6144042-14404273.74075.51
极限1147582-14758275.55278.282.7777.5380.432.78
2151414-15141477.51479.72
3157302-15730280.52882.75
4149089-14908976.32478.46
5157640-15764080.70182.87
6154484-15448479.08581.27
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.182121322123952123652119802121492122040.09
216.222126202131272128740.17
单位质量响应值RSD%判断
13115.2013124.170.05数据可信
供试品溶液-2022060602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%
5min126417-2641713.47314.979.9213.4714.969.92
230369-3036915.48815.49
333612-3361217.14217.14
431224-3122415.92415.92
528238-2823814.40214.40
626215-2621513.37013.37
10min181041-8104141.33142.264.6941.4142.354.67
285166-8516643.43543.52
382471-8247142.06142.16
479796-7979640.69640.78
579247-7924740.41640.50
689498-8949845.64545.72
15min1117242-11724259.79460.261.6760.1060.581.67
2120868-12086861.64361.97
3119646-11964661.02061.35
4117893-11789360.12660.44
5115194-11519458.75059.05
6118134-11813460.24960.58
20min1129664-12966466.12966.381.5666.7767.031.55
2131368-13136866.99867.67
3131062-13106266.84267.51
4132943-13294367.80268.45
5128389-12838965.47966.11
6127476-12747665.01465.68
30min1134849-13484968.77468.871.7469.7869.891.73
2137808-13780870.28371.32
3132537-13253767.59568.63
4137998-13799870.38071.41
5133578-13357868.12669.12
6133408-13340868.03969.06
45min1138076-13807670.42071.632.3371.8173.032.31
2143591-14359173.23274.66
3143660-14366073.26774.68
4142959-14295972.91074.33
5136825-13682569.78271.15
6137592-13759270.17371.57
60min1140051-14005171.42772.792.4373.2074.592.40
2145761-14576174.33976.18
3143314-14331473.09174.91
4147545-14754575.24977.07
5140992-14099271.90773.67
6138622-13862270.69872.49
极限1153731-15373178.40478.351.4880.5880.561.48
2154377-15437778.73380.99
3154904-15490479.00281.23
4156712-15671279.92482.16
5151536-15153677.28479.44
6150508-15050876.76078.94
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