盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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%
115.992090172091362088482086062087132088640.11
216.032098052103912100980.20
单位质量响应值RSD%判断
13062.1613106.550.24数据可信
供试品溶液-2024042521批-pH6.8(内含0.02%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138756-3875619.84717.8230.3119.8517.8230.31
218416-184169.4319.43
334981-3498117.91417.91
426745-2674513.69613.70
544422-4442222.74922.75
645502-4550223.30223.30
10min1120234-12023461.57267.5910.7361.5767.5910.73
2139694-13969471.53871.54
3112288-11228857.50357.50
4134273-13427368.76168.76
5133212-13321268.21868.22
6152218-15221877.95177.95
15min1158248-15824881.03985.364.7181.0485.364.71
2173756-17375688.98188.98
3164009-16400983.98983.99
4165806-16580684.91084.91
5160002-16000281.93781.94
6178264-17826491.28991.29
20min1170785-17078587.45989.553.8287.4689.543.82
2179792-17979292.07292.07
3171998-17199888.08088.08
4171801-17180187.98087.98
5168682-16868286.38286.38
6186104-18610495.30495.30
30min1170662-17066287.39690.484.2487.4090.484.24
2181273-18127392.83092.83
3175234-17523489.73889.74
4175760-17576090.00790.01
5168292-16829286.18386.18
6188914-18891496.74396.74
45min1177459-17745990.87791.442.7290.8891.442.72
2181630-18163093.01393.01
3174182-17418289.19989.20
4176584-17658490.42990.43
5174697-17469789.46389.46
6186852-18685295.68795.69
60min1174370-17437089.29590.953.5489.3090.963.54
2182401-18240193.40893.41
3175267-17526789.75489.75
4175483-17548389.86589.87
5170407-17040787.26687.27
6187716-18771696.13096.13
极限1180507-18050792.43894.091.6392.4494.091.63
2184928-18492894.70294.70
3186073-18607395.28895.29
4184105-18410594.28094.28
5179758-17975892.05492.05
6187070-18707095.79995.80
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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%
115.992095992095812099622098632095222097050.10
216.032107772115602111680.27
单位质量响应值RSD%判断
13114.7613173.300.32数据可信
供试品溶液-2024042621批-pH6.8(内含0.02%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139781-3978120.27920.0127.0320.2820.0127.03
234952-3495217.81817.82
346072-4607223.48623.49
420123-2012310.25810.26
546095-4609523.49823.50
648437-4843724.69224.69
10min1141568-14156872.16875.313.9272.1775.313.92
2149946-14994676.43976.44
3151956-15195677.46477.46
4154555-15455578.78978.79
5148388-14838875.64575.64
6140012-14001271.37571.37
15min1171975-17197587.66989.112.6187.6789.112.61
2171871-17187187.61687.62
3172196-17219687.78287.78
4177390-17739090.42990.43
5183011-18301193.29593.29
6172333-17233387.85287.85
20min1178639-17863991.06692.252.8791.0792.262.86
2177522-17752290.49790.50
3174680-17468089.04889.05
4184160-18416093.88193.88
5189115-18911596.40796.41
6181694-18169492.62492.62
30min1180725-18072592.13093.742.7092.1393.742.70
2180922-18092292.23092.23
3178599-17859991.04691.05
4185071-18507194.34594.35
5192333-19233398.04798.05
6185614-18561494.62294.62
45min1177443-17744390.45692.702.9990.4692.702.99
2179183-17918391.34391.34
3174990-17499089.20689.21
4184621-18462194.11694.12
5188956-18895696.32696.33
6185822-18582294.72894.73
60min1174048-17404888.72691.663.5488.7391.663.54
2176454-17645489.95289.95
3171992-17199287.67887.68
4185385-18538594.50594.51
5184856-18485694.23594.24
6186130-18613094.88594.88
极限1183489-18348993.53996.802.7793.5496.802.77
2189619-18961996.66496.66
3184312-18431293.95893.96
4191670-19167097.70997.71
5197063-197063100.458100.46
6193185-19318598.48198.48
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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%
115.992089612086952086302088672083082086920.13
216.032107482101982104730.19
单位质量响应值RSD%判断
13051.4113129.940.43数据可信
供试品溶液-2024042721批-pH6.8(内含0.02%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14669-46692.3908.2346.742.398.2346.76
213897-138977.1137.11
323644-2364412.10212.10
412181-121816.2356.23
517470-174708.9428.94
624635-2463512.61012.61
10min1110677-11067756.65166.7210.8956.6566.7210.89
2133696-13369668.43368.43
3130384-13038466.73866.74
4128038-12803865.53765.54
5124983-12498363.97363.97
6154295-15429578.97778.98
15min1150392-15039276.97983.574.9376.9883.574.93
2169334-16933486.67586.67
3161643-16164382.73882.74
4160452-16045282.12982.13
5164030-16403083.96083.96
6173750-17375088.93588.94
20min1162364-16236483.10787.643.4283.1187.643.42
2173762-17376288.94188.94
3169606-16960686.81486.81
4169787-16978786.90786.91
5171596-17159687.83387.83
6180237-18023792.25692.26
30min1170239-17023987.13891.053.1787.1491.063.17
2180320-18032092.29892.30
3175949-17594990.06190.06
4177540-17754090.87590.88
5176079-17607990.12790.13
6187220-18722095.83095.83
45min1173937-17393789.03190.301.9689.0390.301.96
2180513-18051392.39792.40
3173461-17346188.78788.79
4174761-17476189.45389.45
5174739-17473989.44189.44
6181131-18113192.71392.71
60min1174896-17489689.52289.923.0289.5289.923.02
2178107-17810791.16591.17
3170913-17091387.48387.48
4169960-16996086.99587.00
5175665-17566589.91589.92
6184512-18451294.44494.44
极限1172259-17225988.17292.472.5088.1792.472.50
2180392-18039292.33592.33
3183644-18364494.00094.00
4179817-17981792.04192.04
5184120-18412094.24394.24
6183683-18368394.02094.02
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