坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067605276106762647615576074761300.12
216.077677376623766980.14
单位质量响应值RSD%判断
4740.354772.740.49数据可信
供试品溶液-12423607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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11319-13191.5571.2552.291.561.2552.31
2-0.0000.00
31407-14071.6611.66
41147-11471.3541.35
51524-15241.7991.80
6974-9741.1501.15
15min11845-18452.1782.0317.062.182.0317.22
21207-12071.4251.42
31671-16711.9721.97
41748-17482.0632.07
52105-21052.4842.49
61750-17502.0652.07
20min12301-23012.7162.8515.172.722.8615.19
21843-18432.1752.18
32455-24552.8972.90
42425-24252.8622.87
52983-29833.5213.53
62502-25022.9532.96
30min13071-30713.6243.558.143.643.568.16
22800-28003.3053.31
33336-33363.9373.95
42666-26663.1463.16
53172-31723.7443.76
62989-29893.5283.54
45min13527-35274.1634.246.474.184.256.46
23334-33343.9353.95
33413-34134.0284.05
43557-35574.1984.21
53975-39754.6914.71
63730-37304.4024.42
60min13789-37894.4724.507.484.504.537.41
24014-40144.7374.76
33640-36404.2964.32
43626-36264.2804.30
53532-35324.1694.20
64284-42845.0565.08
120min14208-42084.9665.066.365.005.106.36
24125-41254.8684.89
34324-43245.1035.13
44642-46425.4795.51
54543-45435.3625.40
63905-39054.6094.64
240min14635-46355.4705.544.585.515.584.52
24645-46455.4825.52
34403-44035.1975.24
45044-50445.9535.99
54802-48025.6675.71
64617-46175.4495.49
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限14682-46825.5265.652.755.575.692.74
24620-46205.4535.50
34699-46995.5465.59
44901-49015.7845.83
54872-48725.7505.80
64928-49285.8165.86
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067638176448765177644076459764490.07
216.077691776901769090.02
单位质量响应值RSD%判断
4760.214785.870.39数据可信
供试品溶液-12423607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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.19244.950.000.19244.95
2-0.0000.00
3-0.0000.00
4964-9641.1341.13
5-0.0000.00
6-0.0000.00
15min11223-12231.4381.6536.641.441.6536.50
2940-9401.1061.11
32349-23492.7632.76
41548-15481.8211.82
51343-13431.5801.58
61011-10111.1891.19
20min12080-20802.4462.4817.802.452.4817.80
21690-16901.9881.99
32762-27623.2493.25
42267-22672.6662.67
51939-19392.2812.28
61896-18962.2302.23
30min13055-30553.5933.228.303.603.238.29
22652-26523.1193.12
32985-29853.5113.52
42491-24912.9302.94
52580-25803.0343.04
62678-26783.1503.16
45min13499-34994.1154.033.154.134.043.07
23458-34584.0674.08
33257-32573.8313.85
43431-34314.0354.05
53345-33453.9343.95
63555-35554.1814.19
60min14049-40494.7624.465.974.784.485.93
23652-36524.2954.31
33963-39634.6614.68
43731-37314.3884.41
53909-39094.5984.62
63441-34414.0474.07
120min13781-37814.4474.818.124.474.848.09
24074-40744.7924.82
34469-44695.2565.29
43680-36804.3284.36
54466-44665.2535.28
64062-40624.7784.80
240min14968-49685.8435.199.605.885.239.53
24300-43005.0575.09
34918-49185.7845.82
44209-42094.9504.99
54006-40064.7124.75
64076-40764.7944.83
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限14600-46005.4105.393.585.455.443.60
24302-43025.0605.10
34635-46355.4515.50
44746-47465.5825.63
54722-47225.5545.60
64503-45035.2965.34
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