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%
115.992114032150962142422131172137212135160.65
216.002157582135642146610.73
单位质量响应值RSD%判断
13353.1013416.310.34数据可信
供试品溶液-2024042721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%
5min134867-3486717.45524.7032.1417.4524.7032.15
229823-2982314.93014.93
346293-4629323.17523.17
470948-7094835.51735.52
563031-6303131.55431.55
651062-5106225.56225.56
10min1122319-12231961.23464.345.2361.3364.475.27
2118653-11865359.39959.48
3133796-13379666.98067.11
4135305-13530567.73567.93
5128553-12855364.35564.53
6132455-13245566.30966.45
15min1151282-15128275.73475.342.1276.1775.832.13
2146540-14654073.36073.77
3155787-15578777.98978.49
4151374-15137475.78076.35
5148224-14822474.20374.74
6149708-14970874.94675.46
20min1157452-15745278.82278.221.1879.6879.131.20
2153280-15328076.73477.55
3157519-15751978.85679.79
4155827-15582778.00979.00
5158169-15816979.18180.13
6155243-15524377.71678.64
30min1169420-16942084.81482.811.3886.1184.161.32
2165864-16586483.03384.28
3166179-16617983.19184.56
4163679-16367981.94083.37
5163937-16393782.06983.45
6163414-16341481.80783.17
45min1170857-17085785.53382.282.5887.3084.092.46
2168082-16808284.14485.85
3163224-16322481.71283.55
4159675-15967579.93581.82
5161809-16180981.00382.84
6162501-16250181.35083.16
60min1162158-16215881.17881.001.9883.4283.261.90
2166071-16607183.13785.31
3161091-16109180.64482.93
4163448-16344881.82484.15
5161650-16165080.92483.21
6156380-15638078.28680.55
极限1166567-16656783.38584.812.5186.0887.522.42
2170644-17064485.42688.06
3173851-17385187.03289.77
4163271-16327181.73584.52
5174002-17400287.10789.85
6168104-16810484.15586.85
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%
115.992152512165372161852133272155912153780.59
216.002158612165772162190.24
单位质量响应值RSD%判断
13469.5413513.690.24数据可信
供试品溶液-2024042721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%
5min150392-5039225.02732.4522.4925.0332.4522.49
269516-6951634.52534.52
379700-7970039.58239.58
477844-7784438.66138.66
544123-4412321.91321.91
670427-7042734.97734.98
10min1133565-13356566.33465.853.3166.4766.023.35
2130326-13032664.72664.92
3137388-13738868.23368.45
4136683-13668367.88368.10
5125544-12554462.35162.47
6131977-13197765.54565.74
15min1154652-15465276.80774.772.4177.3175.322.40
2150007-15000774.50075.05
3150288-15028874.64075.24
4154843-15484376.90277.49
5147617-14761773.31373.78
6145934-14593472.47773.04
20min1162730-16273080.81978.952.3081.7579.912.31
2158735-15873578.83579.80
3162323-16232380.61781.63
4160711-16071179.81680.84
5154020-15402076.49377.37
6155271-15527177.11478.08
30min1168011-16801183.44280.952.2184.8282.342.17
2162269-16226980.59081.99
3160402-16040279.66381.12
4165872-16587282.37983.84
5163259-16325981.08182.38
6158107-15810778.52379.91
45min1163478-16347881.19081.340.8483.0483.190.81
2166086-16608682.48584.34
3161898-16189880.40682.31
4163905-16390581.40283.32
5164087-16408781.49383.24
6163245-16324581.07582.90
60min1165699-16569982.29380.271.9784.5982.571.95
2164504-16450481.70084.01
3161284-16128480.10182.45
4159763-15976379.34581.72
5156916-15691677.93180.13
6161618-16161880.26682.54
极限1165011-16501181.95282.982.2884.7185.732.23
2173924-17392486.37889.14
3164055-16405581.47784.27
4169092-16909283.97886.79
5165994-16599482.44085.08
6164445-16444581.67084.39
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