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%
115.722041232047222039222039412050112043440.25
215.672043772053412048590.34
单位质量响应值RSD%判断
12998.9813073.320.41数据可信
加速6月-供试品溶液-2024042221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114262-142627.33112.8840.407.3312.8840.40
227871-2787114.32614.33
316417-164178.4388.44
432887-3288716.90416.90
539767-3976720.44020.44
619111-191119.8239.82
10min1149141-14914176.65884.4611.6076.7084.5311.59
2174592-17459289.74089.82
3173878-17387889.37389.42
4132721-13272168.21868.31
5181443-18144393.26193.37
6174160-17416089.51889.57
15min1181758-18175893.42397.622.9393.8998.162.94
2190807-19080798.07498.65
3189174-18917497.23597.78
4195075-195075100.268100.74
5196600-196600101.052101.68
6186080-18608095.64596.20
20min1187254-18725496.24898.593.0797.2399.673.03
2186773-18677396.00197.12
3197460-197460101.494102.58
4200455-200455103.033104.06
5191530-19153098.44699.64
6187376-18737696.31197.39
30min1185507-18550795.35099.163.2196.87100.803.18
2194364-19436499.903101.56
3198896-198896102.232103.88
4200420-200420103.015104.62
5191873-19187398.622100.36
6186508-18650895.86597.48
45min1188823-18882397.05599.472.7999.10101.652.76
2191500-19150098.431100.64
3201317-201317103.476105.69
4199006-199006102.289104.46
5192091-19209198.734101.02
6188451-18845196.86399.01
极限1187231-18723196.23698.292.4798.83101.032.43
2189668-18966897.489100.25
3197845-197845101.692104.48
4196319-196319100.908103.65
5186740-18674095.98498.82
6189571-18957197.439100.13
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%
115.722042492043822041332039992040442041610.08
215.672060232070232065230.35
单位质量响应值RSD%判断
12987.3413179.511.04数据可信
加速6月-供试品溶液-2024042321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118738-187389.59710.5442.159.6010.5442.13
227692-2769214.18314.18
311622-116225.9525.95
430321-3032115.52915.53
525615-2561513.11913.12
69539-95394.8864.89
10min1114394-11439458.58864.6620.9058.6464.7220.90
2171504-17150487.83887.92
3100669-10066951.55951.59
4137130-13713070.23370.32
5103827-10382753.17653.25
6129994-12999466.57866.61
15min1184466-18446694.47796.291.8494.8696.711.84
2191609-19160998.13598.70
3189728-18972897.17297.49
4183404-18340493.93394.41
5191169-19116997.91098.28
6187668-18766896.11796.51
20min1186326-18632695.42997.542.3796.3398.492.35
2193757-19375799.235100.35
3193484-19348499.09699.95
4183618-18361894.04395.04
5194618-19461899.676100.59
6190901-19090197.77398.70
30min1187532-18753296.04797.142.0897.4898.632.04
2192367-19236798.523100.19
3195350-195350100.051101.46
4184093-18409394.28695.81
5190248-19024897.43898.90
6188397-18839796.49097.96
45min1182550-18255093.49695.092.9295.4697.122.88
2189519-18951997.06599.28
3193011-19301198.853100.82
4180388-18038892.38894.43
5188476-18847696.53198.54
6179981-17998192.18094.19
极限1185817-18581795.16995.632.7097.6698.192.67
2192431-19243198.556101.31
3189804-18980497.21199.73
4178813-17881391.58294.14
5183440-18344093.95196.49
6189963-18996397.29299.81
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%
115.722071702091192086302074862066112078030.51
215.672069192061882065540.26
单位质量响应值RSD%判断
13219.0213181.490.21数据可信
加速6月-供试品溶液-2024042421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min126560-2656013.4828.6145.9813.488.6145.97
211978-119786.0806.08
314431-144317.3257.33
48067-80674.0954.09
526621-2662113.51313.51
614103-141037.1597.16
10min178677-7867739.93746.2017.1240.0146.2417.11
281970-8197041.60841.64
3113053-11305357.38657.43
472862-7286236.98537.01
597315-9731549.39849.47
6102172-10217251.86351.90
15min1188692-18869295.78195.342.7096.0895.642.75
2185626-18562694.22594.49
3193324-19332498.13298.49
4178939-17893990.83091.06
5191345-19134597.12897.48
6188995-18899595.93596.26
20min1193629-19362998.28798.681.8399.1299.511.84
2189328-18932896.10496.89
3198735-198735100.879101.78
4196551-19655199.770100.50
5196630-19663099.810100.70
6191502-19150297.20798.07
30min1197367-197367100.18499.541.90101.56100.921.90
2190240-19024096.56797.89
3200612-200612101.832103.30
4198279-198279100.647101.93
5196732-19673299.862101.31
6193350-19335098.14599.55
45min1191270-19127097.09098.501.8699.02100.441.86
2190878-19087896.89198.75
3199122-199122101.075103.11
4195984-19598499.482101.33
5196425-19642599.706101.70
6190607-19060796.75398.70
极限1194216-19421698.58598.621.60101.06101.101.62
2188876-18887695.87498.27
3196590-19659099.790102.38
4195990-19599099.485101.88
5197211-197211100.105102.66
6192782-19278297.857100.34
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