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D69223050102对照品来源中检院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%
119.202014372013072014572014662015272014390.05
219.122012432009762011100.10
单位质量响应值RSD%判断
10491.6110518.310.18数据可信
供试品溶液-24041601批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12822-28221.4080.5478.031.410.5478.49
2765-7650.3820.38
3599-5990.2990.30
4786-7860.3920.39
5728-7280.3630.36
6851-8510.4240.42
10min1968-9680.4830.465.410.500.466.34
2862-8620.4300.43
3967-9670.4820.49
4869-8690.4330.44
5941-9410.4690.47
6882-8820.4400.44
15min11108-11080.5530.533.460.570.543.77
21056-10560.5270.54
31019-10190.5080.52
41031-10310.5140.52
51102-11020.5500.56
61061-10610.5290.54
20min11246-12460.6220.602.310.650.623.05
21212-12120.6050.62
31174-11740.5860.60
41173-11730.5850.60
51192-11920.5950.61
61197-11970.5970.61
30min11603-16030.8000.782.210.830.802.32
21551-15510.7740.80
31527-15270.7620.78
41531-15310.7640.79
51606-16060.8010.82
61555-15550.7760.80
45min11938-19380.9670.933.491.010.963.76
21900-19000.9480.98
31941-19410.9681.00
41804-18040.9000.93
51804-18040.9000.93
61826-18260.9110.94
60min12083-20831.0391.041.371.091.081.37
22110-21101.0531.09
32045-20451.0201.06
42047-20471.0211.06
52077-20771.0361.08
62107-21071.0511.09
极限12373-23731.1841.237.961.251.287.58
22313-23131.1541.21
32481-24811.2381.29
42361-23611.1781.23
52368-23681.1811.23
62839-28391.4161.47
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D69223050102对照品来源中检院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%
119.202012292011242009822008292002532008830.20
219.121999831998441999140.05
单位质量响应值RSD%判断
10462.6610455.750.05数据可信
供试品溶液-24041701批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1767-7670.3840.4940.450.380.4941.04
2663-6630.3320.33
31570-15700.7870.79
4688-6880.3450.34
5817-8170.4090.41
61415-14150.7090.71
10min11015-10150.5090.516.540.510.526.92
2972-9720.4870.49
31008-10080.5050.51
4936-9360.4690.47
51063-10630.5330.54
61124-11240.5630.57
15min11120-11200.5610.615.240.570.625.71
21212-12120.6070.62
31223-12230.6130.63
41209-12090.6060.61
51235-12350.6190.63
61320-13200.6610.68
20min11289-12890.6460.694.110.660.714.33
21429-14290.7160.73
31423-14230.7130.73
41335-13350.6690.68
51399-13990.7010.72
61416-14160.7090.73
30min11712-17120.8580.884.200.880.904.30
21680-16800.8420.87
31790-17900.8970.93
41709-17090.8560.88
51731-17310.8670.89
61881-18810.9420.97
45min12106-21061.0551.031.911.091.072.14
22008-20081.0061.04
32094-20941.0491.09
42030-20301.0171.05
52047-20471.0261.06
62088-20881.0461.09
60min12277-22771.1411.164.761.191.214.67
22190-21901.0971.14
32286-22861.1451.20
42279-22791.1421.19
52517-25171.2611.31
62339-23391.1721.22
极限12494-24941.2501.272.511.311.332.72
22446-24461.2251.28
32524-25241.2651.33
42542-25421.2741.33
52525-25251.2651.33
62637-26371.3211.39
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