美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222078602074942082832072912077532077360.19
219.032077542087422082480.34
单位质量响应值RSD%判断
10808.3210943.140.88数据可信
供试品溶液-2023082021批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11456-14560.7020.668.930.700.668.66
21398-13980.6740.67
31411-14110.6800.68
41135-11350.5470.55
51454-14540.7010.70
61326-13260.6390.64
10min11282-12820.6180.769.710.630.779.33
21702-17020.8200.83
31629-16290.7850.79
41567-15670.7550.76
51629-16290.7850.79
61676-16760.8080.81
15min11779-17790.8570.804.840.870.824.63
21710-17100.8240.84
31586-15860.7640.78
41685-16850.8120.83
51647-16470.7940.81
61562-15620.7530.77
20min11748-17480.8420.873.750.870.903.55
21823-18230.8780.90
31919-19190.9250.95
41813-18130.8740.90
51835-18350.8840.91
61731-17310.8340.86
30min11879-18790.9050.886.600.940.916.34
21986-19860.9570.99
31670-16700.8050.84
41820-18200.8770.91
51879-18790.9050.94
61695-16950.8170.85
45min11832-18320.8830.924.970.930.964.89
21997-19970.9621.01
31872-18720.9020.95
41761-17610.8490.89
51998-19980.9631.01
61932-19320.9310.97
60min11871-18710.9020.912.930.950.963.06
21968-19680.9481.01
31876-18760.9040.96
41914-19140.9220.97
51895-18950.9130.97
61800-18000.8670.92
极限11970-19700.9490.952.251.011.012.12
21926-19260.9281.00
31960-19600.9441.01
42013-20130.9701.03
52018-20180.9721.04
61909-19090.9200.98
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222073642074272071652072252071622072690.06
219.032056602059892058240.12
单位质量响应值RSD%判断
10784.0310815.760.21数据可信
供试品溶液-t2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11299-12990.6300.628.690.630.628.93
21267-12670.6150.61
31455-14550.7060.71
41246-12460.6050.60
51258-12580.6100.61
61111-11110.5390.54
10min11540-15400.7470.805.000.750.804.96
21736-17360.8420.85
31584-15840.7690.78
41614-16140.7830.79
51660-16600.8050.81
61744-17440.8460.85
15min11814-18140.8800.855.010.900.874.99
21780-17800.8640.88
31728-17280.8380.85
41761-17610.8540.87
51598-15980.7750.79
61849-18490.8970.91
20min11790-17900.8690.873.040.890.892.79
21716-17160.8330.86
31863-18630.9040.93
41805-18050.8760.90
51813-18130.8800.90
61734-17340.8410.87
30min11829-18290.8870.866.340.920.906.07
21944-19440.9430.98
31617-16170.7850.82
41693-16930.8210.86
51768-17680.8580.89
61789-17890.8680.90
45min12035-20350.9870.924.431.030.964.08
21895-18950.9190.96
31934-19340.9380.98
41778-17780.8630.91
51880-18800.9120.96
61869-18690.9070.95
60min12113-21131.0250.964.271.081.013.99
21971-19710.9561.01
31923-19230.9330.99
41933-19330.9380.99
52037-20370.9881.04
61884-18840.9140.97
极限12162-21621.0490.974.941.121.044.78
21947-19470.9451.01
31941-19410.9421.01
41882-18820.9130.98
52041-20410.9901.06
62023-20230.9821.05
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222055122049652052582048022050432051160.14
219.031999112005782002440.24
单位质量响应值RSD%判断
10672.0110522.541.00数据可信
供试品溶液-2023082121批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11304-13040.6450.626.220.640.625.80
21197-11970.5920.59
31249-12490.6180.62
41262-12620.6240.62
51163-11630.5750.58
61384-13840.6840.68
10min11555-15550.7690.756.020.780.766.13
21484-14840.7340.74
31600-16000.7910.80
41368-13680.6760.68
51603-16030.7930.80
61471-14710.7270.74
15min11617-16170.8000.813.450.820.823.31
21615-16150.7990.81
31543-15430.7630.78
41710-17100.8460.86
51625-16250.8040.82
61666-16660.8240.84
20min11734-17340.8570.8211.690.880.8411.47
21462-14620.7230.75
31885-18850.9320.96
41424-14240.7040.73
51595-15950.7890.81
61841-18410.9100.94
30min11828-18280.9040.864.260.940.904.31
21736-17360.8580.89
31805-18050.8930.93
41702-17020.8420.87
51627-16270.8050.84
61784-17840.8820.92
45min11856-18560.9180.884.270.960.934.25
21717-17170.8490.89
31805-18050.8930.94
41869-18690.9240.97
51676-16760.8290.87
61798-17980.8890.93
60min11937-19370.9580.934.771.010.984.55
21799-17990.8900.94
31837-18370.9080.96
41986-19860.9821.03
51762-17620.8710.92
61936-19360.9571.01
极限11980-19800.9790.954.811.041.014.57
21997-19970.9881.05
32003-20030.9901.05
41762-17620.8710.93
51901-19010.9401.00
61890-18900.9351.00
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