达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.601979431982681982291982841983301982110.08
212.631999051996941998000.08
单位质量响应值RSD%判断
15731.0315819.480.40数据可信
供试品溶液-24111501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1138838-13883870.97069.366.4970.9769.366.49
2136084-13608469.56369.56
3123510-12351063.13563.14
4127108-12710864.97464.97
5146294-14629474.78274.78
6142256-14225672.71872.72
10min1155149-15514979.30878.014.8679.4178.114.87
2155783-15578379.63279.74
3141281-14128172.21972.31
4146379-14637974.82574.92
5161771-16177182.69382.81
6155296-15529679.38379.49
15min1158696-15869681.12179.693.4081.3579.913.40
2157126-15712680.31980.54
3147925-14792575.61575.82
4151193-15119377.28677.50
5162192-16219282.90883.14
6158242-15824280.88981.12
20min1160630-16063082.11080.813.2282.4681.153.23
2160252-16025281.91782.26
3150248-15024876.80377.12
4153393-15339378.41178.74
5163420-16342083.53683.90
6160593-16059382.09182.44
30min1163243-16324383.44682.232.9083.9282.692.91
2162644-16264483.13983.61
3153641-15364178.53778.97
4156594-15659480.04780.49
5165687-16568784.69585.18
6163336-16333683.49383.97
45min1165938-16593884.82383.882.6285.4284.472.63
2166267-16626784.99185.58
3157128-15712880.32080.87
4160649-16064982.12082.68
5168443-16844386.10486.72
6166173-16617384.94385.54
60min1168632-16863286.20085.302.5586.9286.012.56
2169841-16984186.81887.54
3159966-15996681.77082.44
4163184-16318483.41584.10
5170208-17020887.00687.75
6169353-16935386.56987.29
极限1198237-198237101.334101.751.35102.19102.581.34
2200539-200539102.510103.36
3196765-196765100.581101.37
4203590-203590104.070104.88
5196348-196348100.368101.24
6198790-198790101.616102.47
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.601985811986911985911985691981941985250.10
212.631990991990371990680.03
单位质量响应值RSD%判断
15755.9515761.520.03数据可信
供试品溶液-24111501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%
5min1136285-13628569.73872.773.3169.7472.773.31
2139062-13906271.15971.16
3141225-14122572.26672.27
4145749-14574974.58174.58
5149381-14938176.43976.44
6141575-14157572.44572.44
10min1156220-15622079.93982.892.9980.0483.002.99
2161242-16124282.50982.62
3156747-15674780.20880.32
4168194-16819486.06686.18
5163890-16389083.86383.98
6165636-16563684.75784.87
15min1161073-16107382.42285.382.9782.6585.622.97
2167116-16711685.51485.74
3161536-16153682.65982.89
4173922-17392288.99789.24
5167399-16739985.65985.90
6170108-17010887.04587.28
20min1163347-16334783.58686.232.9383.9386.602.93
2169599-16959986.78587.14
3162248-16224883.02383.38
4175129-17512989.61589.99
5169119-16911986.53986.91
6171688-17168887.85488.22
30min1165786-16578684.83487.502.9285.3187.992.91
2172767-17276788.40688.89
3164450-16445084.15084.63
4177212-17721290.68091.19
5171224-17122487.61688.12
6174486-17448689.28689.78
45min1168342-16834286.14288.892.7686.7489.512.76
2174819-17481989.45690.08
3167719-16771985.82386.43
4179845-17984592.02892.67
5174681-17468189.38590.02
6176873-17687390.50791.14
60min1170668-17066887.33289.732.6488.0690.482.64
2176517-17651790.32591.08
3169502-16950286.73587.47
4181449-18144992.84993.63
5175130-17513089.61590.38
6178831-17883191.50992.28
极限1199483-199483102.077101.651.10102.94102.541.10
2201566-201566103.143104.03
3195723-195723100.153101.01
4199017-199017101.838102.76
5199663-199663102.169103.07
6196477-196477100.538101.44
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