阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.071019651018651019501019611021481019780.11
2 10.151018791017761018280.08
单位质量响应值RSD%判断
10126.9110032.320.67数据可信
中间条件24月-供试品溶液-542916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%
5min131485-3148528.02925.8816.1428.0325.8816.15
224886-2488622.15422.15
331621-3162128.15028.15
421657-2165719.28019.28
533640-3364029.94729.95
631170-3117027.74927.75
10min176507-7650768.10961.6511.9968.2661.7911.99
267890-6789060.43860.56
368449-6844960.93661.09
453888-5388847.97348.08
573843-7384365.73765.90
674917-7491766.69466.85
15min198662-9866287.83283.863.8188.3784.353.85
294082-9408283.75584.21
391876-9187681.79182.29
488570-8857078.84879.22
595425-9542584.95085.48
696596-9659685.99386.52
20min1107843-10784396.00592.713.6997.0393.663.70
2102754-10275491.47592.40
3100438-10043889.41390.36
4101577-10157790.42791.24
5109976-10997697.90498.91
6102233-10223391.01192.01
30min1112939-112939100.54296.523.20102.1097.983.18
2107824-10782495.98897.42
3103586-10358692.21693.66
4109817-10981797.76399.08
5110802-11080298.640100.19
6105535-10553593.95195.46
45min1114466-114466101.90197.013.84104.0299.013.81
2107874-10787496.03398.00
3102946-10294691.64693.60
4109642-10964297.60799.46
5112489-112489100.141102.24
6106402-10640294.72296.75
60min1112297-11229799.97096.103.02102.6598.653.02
2106236-10623694.57597.07
3103042-10304291.73194.20
4108268-10826896.38498.78
5110515-11051598.384101.04
6107370-10737095.58498.14
极限1108121-10812196.25397.360.7799.49100.430.71
2110532-11053298.399101.42
3108859-10885996.91099.89
4109283-10928397.287100.22
5109406-10940697.397100.60
6109963-10996397.893100.98
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.071016211017011016791017931016291016850.07
2 10.151010211013341011780.22
单位质量响应值RSD%判断
10097.829968.280.92数据可信
中间条件24月-供试品溶液-542916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%
5min131489-3148928.16324.9631.2028.1624.9631.19
240080-4008035.84735.85
324510-2451021.92121.92
423356-2335620.88920.89
532840-3284029.37229.37
615204-1520413.59813.60
10min171219-7121963.69757.8914.5963.8558.0214.62
272892-7289265.19365.39
363797-6379757.05957.18
460714-6071454.30254.42
571515-7151563.96264.12
648190-4819043.10043.18
15min194739-9473984.73380.838.1785.2481.298.22
299507-9950788.99789.56
386549-8654977.40877.85
481962-8196273.30573.72
596205-9620586.04486.56
683279-8327974.48374.80
20min1108397-10839796.94893.305.1597.9394.215.16
2104469-10446993.43594.49
3106885-10688595.59696.46
494114-9411484.17485.00
5108365-10836596.92097.92
6103706-10370692.75393.48
30min1108839-10883997.34495.462.1298.8696.892.13
2105246-10524694.13095.70
3106814-10681495.53396.93
4103000-10300092.12193.41
5108517-10851797.05698.59
6107993-10799396.58797.83
45min1107477-10747796.12594.553.2098.1996.513.15
2101478-10147890.76092.86
3107521-10752196.16598.10
4101291-10129190.59392.40
5108513-10851397.05299.13
6108033-10803396.62398.40
60min1107956-10795696.55495.042.4299.1597.532.41
2104004-10400493.01995.62
3107379-10737996.03898.50
4102125-10212591.33993.65
5108266-10826696.83199.44
6107875-10787596.48198.80
极限1109108-10910897.58496.001.34100.7299.011.24
2105377-10537794.24797.37
3107870-10787096.47799.48
4108109-10810996.69199.51
5105851-10585194.67197.82
6107687-10768796.31399.17
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