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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.762226602221292228192223982214072222830.25
215.792186062186012186040.01
单位质量响应值RSD%判断
14104.2513844.461.32数据可信
供试品溶液-2024042421批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129314-2931414.05720.0834.1914.0620.0834.18
230124-3012414.44514.45
361995-6199529.72829.73
428756-2875613.78913.79
551600-5160024.74424.74
649401-4940123.68923.69
10min1144922-14492269.49465.897.9769.5766.007.97
2132837-13283763.69963.78
3155748-15574874.68574.85
4135027-13502764.74964.83
5128516-12851661.62761.76
6127410-12741061.09761.23
15min1158193-15819375.85877.383.0076.3277.852.98
2154001-15400173.84874.28
3159715-15971576.58877.17
4166047-16604779.62480.06
5165242-16524279.23879.72
6164942-16494279.09479.57
20min1159304-15930476.39178.222.2877.2879.132.28
2159097-15909776.29177.14
3165746-16574679.48080.49
4167946-16794680.53581.41
5161369-16136977.38178.30
6165292-16529279.26280.17
30min1159405-15940576.43978.642.1277.7579.982.11
2160422-16042276.92778.19
3163658-16365878.47879.93
4167881-16788180.50381.83
5165660-16566079.43880.79
6166895-16689580.03181.38
45min1157514-15751475.53278.462.5477.2780.242.51
2161398-16139877.39579.09
3163024-16302478.17480.06
4169508-16950881.28483.06
5163616-16361678.45880.25
6166633-16663379.90581.70
60min1156925-15692575.25077.702.7577.4079.912.70
2158442-15844275.97778.10
3159441-15944176.45678.77
4166264-16626479.72881.95
5163281-16328178.29880.52
6167823-16782380.47682.71
极限1155407-15540774.52277.232.5377.0979.882.50
2158531-15853176.02078.57
3159913-15991376.68379.42
4166843-16684380.00682.67
5161529-16152977.45780.12
6164106-16410678.69381.38
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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.762065522072242081412089802094502080690.58
215.792074362077952076160.13
单位质量响应值RSD%判断
13202.3513148.580.29数据可信
供试品溶液-2024042421批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148158-4815824.49126.7424.5524.4926.7424.56
260187-6018730.60930.61
358079-5807929.53729.54
451696-5169626.29126.29
567308-6730834.23034.23
630048-3004815.28115.28
10min1136771-13677169.55669.189.3669.6969.339.37
2123086-12308662.59762.77
3149698-14969876.13176.29
4131215-13121566.73166.88
5152297-15229777.45277.64
6123096-12309662.60262.69
15min1162180-16218082.47882.922.2283.0083.452.27
2159499-15949981.11581.63
3166237-16623784.54285.13
4165375-16537584.10384.62
5166706-16670684.78085.40
6158291-15829180.50180.93
20min1164078-16407883.44483.320.8184.4284.320.84
2165606-16560684.22185.19
3164408-16440883.61284.67
4163958-16395883.38384.37
5163334-16333483.06584.16
6161633-16163382.20083.08
30min1160771-16077181.76282.731.4983.2184.191.47
2165150-16515083.98985.43
3162591-16259182.68784.21
4166048-16604884.44685.89
5161264-16126482.01383.57
6160243-16024381.49382.83
45min1159954-15995481.34681.500.5083.2483.410.47
2161073-16107381.91583.82
3158905-15890580.81382.79
4160055-16005581.39883.31
5160809-16080981.78183.79
6160706-16070681.72983.52
60min1160595-16059581.67281.190.7984.0283.560.71
2157915-15791580.30982.67
3159433-15943381.08183.51
4159667-15966781.20083.57
5158850-15885080.78583.25
6161445-16144582.10584.35
极限1154902-15490278.77780.811.4381.5883.631.43
2159055-15905580.88983.69
3160276-16027681.51084.39
4161086-16108681.92284.74
5160307-16030781.52684.44
6157826-15782680.26482.96
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