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%
115.722050642029882035662018132020072030880.65
215.672033442039682036560.22
单位质量响应值RSD%判断
12919.0812996.550.43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%
5min112908-129086.6758.8841.266.678.8841.28
221176-2117610.95010.95
312584-125846.5076.51
429967-2996715.49615.50
513442-134426.9516.95
612938-129386.6906.69
10min1115269-11526959.60673.0917.9859.6473.1417.98
2156916-15691681.14281.20
3165534-16553485.59985.63
4169929-16992987.87187.96
5122577-12257763.38563.42
6117894-11789460.96461.00
15min1195078-195078100.87696.603.62101.2497.063.61
2195363-195363101.023101.53
3181528-18152893.86994.38
4186080-18608096.22396.80
5181371-18137193.78894.18
6181440-18144093.82494.20
20min1194760-194760100.71198.672.18101.6499.662.21
2192807-19280799.702100.77
3193900-193900100.267101.30
4192245-19224599.411100.52
5185795-18579596.07696.99
6185365-18536595.85396.75
30min1189619-18961998.05397.890.9799.5499.431.03
2190986-19098698.760100.39
3187567-18756796.99298.58
4191489-19148999.020100.68
5189318-18931897.89799.34
6186827-18682796.60998.04
45min1192526-19252699.55697.461.17101.5999.551.16
2187701-18770197.06199.24
3187994-18799497.21399.34
4188992-18899297.72999.94
5187555-18755596.98698.98
6186092-18609296.22998.20
极限1191362-19136298.95496.781.97101.5499.401.97
2187811-18781197.11899.83
3191048-19104898.792101.46
4186468-18646896.42499.18
5183865-18386595.07897.61
6182366-18236694.30296.80
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%
115.722022642039142034262041972045592036720.44
215.672023002042882032940.70
单位质量响应值RSD%判断
12956.2312973.450.10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%
5min112678-126786.5527.6624.486.557.6624.47
222004-2200411.37211.37
314869-148697.6857.68
412780-127806.6056.60
513907-139077.1877.19
612684-126846.5556.56
10min177624-7762440.11842.8213.0440.1542.8613.01
268358-6835835.32935.39
376076-7607639.31839.36
497063-9706350.16450.20
592332-9233247.71947.76
685654-8565444.26844.30
15min1186434-18643496.35392.777.3696.6193.057.35
2153316-15331679.23779.50
3179076-17907692.55092.81
4184926-18492695.57495.89
5184596-18459695.40395.71
6188615-18861597.48097.76
20min1191559-19155999.00297.621.6699.8098.421.66
2189487-18948797.93198.63
3183856-18385695.02195.80
4191768-19176899.11099.96
5190210-19021098.30599.14
6186474-18647496.37497.20
30min1187434-18743496.87098.791.4498.21100.131.45
2190747-19074798.58299.83
3189102-18910297.73299.04
4194126-194126100.328101.73
5194416-194416100.478101.86
6191101-19110198.765100.12
45min1187484-18748496.89697.181.5698.7899.071.53
2189857-18985798.12299.91
3188282-18828297.30899.15
4192304-19230499.387101.34
5186638-18663896.45898.40
6183684-18368494.93296.84
极限1186742-18674296.51296.780.7898.9399.210.82
2186245-18624596.25598.59
3186544-18654496.41098.80
4189473-18947397.924100.43
5188674-18867497.51199.99
6185875-18587596.06498.50
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