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D211-4R701-2402002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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.152092122092782091832092812092612092430.03
218.172092002096132094060.14
单位质量响应值RSD%判断
11528.5411524.820.03数据可信
供试品溶液-12595119批-磷酸盐溶液(pH7.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11805-18050.8760.924.530.880.924.46
22037-20370.9890.99
31812-18120.8800.88
41877-18770.9110.91
51917-19170.9310.93
61921-19210.9330.93
10min12543-25431.2351.214.541.241.224.47
22511-25111.2191.23
32283-22831.1091.12
42616-26161.2701.28
52485-24851.2071.22
62545-25451.2361.25
15min12752-27521.3361.403.331.361.423.35
22882-28821.3991.42
32792-27921.3561.38
42970-29701.4421.47
52996-29961.4551.48
62893-28931.4051.43
20min13263-32631.5841.633.301.621.673.24
23372-33721.6371.68
33316-33161.6101.65
43568-35681.7321.77
53279-32791.5921.63
63350-33501.6271.67
30min13806-38061.8481.854.991.901.914.83
23756-37561.8241.88
33739-37391.8161.87
44038-40381.9612.02
54006-40061.9452.00
63523-35231.7111.77
45min14790-47902.3262.412.882.402.492.85
25006-50062.4312.51
34851-48512.3552.43
45194-51942.5222.60
55032-50322.4432.52
64966-49662.4112.49
60min15916-59162.8732.863.762.972.963.71
25876-58762.8532.96
35572-55722.7062.81
46259-62593.0393.15
55904-59042.8672.97
65804-58042.8182.92
极限15944-59442.8863.135.363.023.265.28
26520-65203.1663.30
36327-63273.0723.20
46967-69673.3833.53
56611-66113.2103.35
66290-62903.0543.19
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D211-4R701-2402002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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.152099112100802098182100522100842099890.06
218.172095732096292096010.02
单位质量响应值RSD%判断
11569.6411535.550.21数据可信
供试品溶液-12595119批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1825-8250.4000.3811.990.400.3811.77
2832-8320.4030.40
3669-6690.3240.32
4938-9380.4540.45
5735-7350.3560.36
6741-7410.3590.36
10min11043-10430.5050.527.580.510.527.42
21184-11840.5740.58
31096-10960.5310.53
41092-10920.5290.53
5938-9380.4540.46
61063-10630.5150.52
15min11119-11190.5420.525.290.550.535.21
21032-10320.5000.51
31129-11290.5470.56
41118-11180.5420.55
5991-9910.4800.49
61055-10550.5110.52
20min11212-12120.5870.544.710.600.564.59
21113-11130.5390.56
31096-10960.5310.55
41126-11260.5460.56
51051-10510.5090.52
61125-11250.5450.56
30min11183-11830.5730.565.000.600.584.81
21090-10900.5280.55
31218-12180.5900.61
41218-12180.5900.61
51093-10930.5300.55
61144-11440.5540.58
45min11339-13390.6490.615.380.680.645.17
21207-12070.5850.61
31252-12520.6070.63
41327-13270.6430.67
51175-11750.5690.60
61312-13120.6360.66
60min11319-13190.6390.652.580.680.692.38
21365-13650.6610.70
31374-13740.6660.70
41367-13670.6620.70
51286-12860.6230.66
61331-13310.6450.68
极限11480-14800.7170.677.650.760.717.37
21326-13260.6420.68
31303-13030.6310.67
41527-15270.7400.78
51368-13680.6630.70
61260-12600.6100.65
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D211-4R701-2402002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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.152097872100872092062091922084962093540.30
218.172082482092882087680.36
单位质量响应值RSD%判断
11534.6611489.710.28数据可信
供试品溶液-12595119批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1998-9980.4850.567.400.490.567.34
21120-11200.5450.54
31225-12250.5960.60
41184-11840.5760.58
51210-12100.5880.59
61198-11980.5820.58
10min11341-13410.6520.736.200.660.736.32
21582-15820.7690.78
31525-15250.7410.75
41456-14560.7080.71
51586-15860.7710.78
61465-14650.7120.72
15min11685-16850.8190.863.330.830.883.45
21736-17360.8440.86
31856-18560.9020.92
41765-17650.8580.87
51772-17720.8610.88
61810-18100.8800.89
20min11691-16910.8220.915.920.840.945.96
21910-19100.9290.95
31870-18700.9090.93
41984-19840.9650.99
51991-19910.9680.99
61838-18380.8940.92
30min12102-21021.0221.083.501.051.113.63
22320-23201.1281.16
32229-22291.0841.12
42181-21811.0601.09
52286-22861.1111.15
62206-22061.0721.11
45min12322-23221.1291.234.451.171.274.47
22568-25681.2481.30
32553-25531.2411.29
42664-26641.2951.34
52514-25141.2221.27
62521-25211.2261.27
60min12517-25171.2241.375.321.281.435.23
22853-28531.3871.45
32858-28581.3891.45
42938-29381.4281.49
52885-28851.4031.46
62820-28201.3711.43
极限12979-29791.4481.483.581.521.563.29
23201-32011.5561.63
33003-30031.4601.54
43163-31631.5381.61
53021-30211.4691.55
62925-29251.4221.50
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