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%
117.401946651946311950421943671950791947570.16
217.411946201949131947660.11
单位质量响应值RSD%判断
11192.9311187.020.04数据可信
供试品溶液-2024122421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%
5min1916-9160.4580.446.150.460.445.83
2792-7920.3960.40
3859-8590.4300.43
4936-9360.4680.47
5884-8840.4420.44
6929-9290.4650.46
10min11182-11820.5910.616.580.600.616.90
21117-11170.5590.56
31226-12260.6130.62
41154-11540.5770.58
51344-13440.6720.68
61243-12430.6220.63
15min11353-13530.6770.713.610.690.733.66
21470-14700.7350.75
31405-14050.7030.71
41470-14700.7350.75
51387-13870.6940.71
61474-14740.7370.75
20min11624-16240.8120.833.570.830.843.41
21700-17000.8500.87
31607-16070.8040.82
41686-16860.8430.86
51578-15780.7890.81
61728-17280.8640.88
30min12197-21971.0991.132.391.131.162.41
22260-22601.1301.16
32230-22301.1151.14
42253-22531.1271.16
52247-22471.1241.15
62357-23571.1791.21
45min12843-28431.4221.524.221.461.564.20
23189-31891.5951.64
32992-29921.4971.54
43162-31621.5821.62
53002-30021.5021.54
63097-30971.5491.59
60min14010-40102.0061.981.172.062.041.01
23966-39661.9842.04
33961-39611.9812.04
43976-39761.9892.05
53972-39721.9872.04
63872-38721.9372.00
极限14384-43842.1932.252.412.272.332.35
24475-44752.2382.32
34581-45812.2912.37
44590-45902.2962.38
54376-43762.1892.27
64622-46222.3122.39
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%
117.401946161947241946641947661944171946370.07
217.411907681907561907620.01
单位质量响应值RSD%判断
11186.0310957.041.47数据可信
供试品溶液-2024122421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%
5min1955-9550.4830.485.860.480.485.81
2974-9740.4920.49
3963-9630.4870.49
41050-10500.5310.53
5915-9150.4630.46
6887-8870.4480.45
10min11176-11760.5950.626.090.600.626.23
21284-12840.6490.65
31126-11260.5690.57
41178-11780.5960.60
51316-13160.6650.67
61268-12680.6410.65
15min11534-15340.7760.753.390.790.763.39
21510-15100.7630.78
31402-14020.7090.72
41521-15210.7690.78
51450-14500.7330.75
61470-14700.7430.76
20min11806-18060.9130.883.540.930.903.13
21704-17040.8610.88
31717-17170.8680.89
41714-17140.8670.89
51806-18060.9130.93
61651-16510.8350.86
30min12236-22361.1301.174.621.161.204.58
22451-24511.2391.27
32222-22221.1231.15
42412-24121.2191.25
52316-23161.1711.20
62195-21951.1101.14
45min13030-30301.5321.562.031.581.601.97
23194-31941.6151.66
33021-30211.5271.57
43097-30971.5661.61
53085-30851.5601.60
63100-31001.5671.61
60min13872-38721.9582.034.442.022.094.39
24363-43632.2062.27
34003-40032.0242.08
43960-39602.0022.06
53900-39001.9722.03
63991-39912.0182.08
极限14373-43732.2112.272.042.292.352.10
24567-45672.3092.40
34388-43882.2182.30
44584-45842.3182.40
54534-45342.2922.38
64466-44662.2582.34
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%
117.401949931951271947531944141943581947290.18
217.411944051940471942260.14
单位质量响应值RSD%判断
11191.3211156.000.23数据可信
供试品溶液-12461045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%
5min11842-18420.9230.925.160.920.925.16
21991-19910.9971.00
31824-18240.9140.91
41768-17680.8860.89
51732-17320.8680.87
61918-19180.9610.96
10min12401-24011.2031.168.211.211.178.13
22569-25691.2871.30
32322-23221.1631.17
42334-23341.1691.18
51992-19920.9981.01
62257-22571.1311.14
15min12601-26011.3031.296.261.331.326.34
22878-28781.4421.47
32452-24521.2281.25
42591-25911.2981.32
52457-24571.2311.25
62488-24881.2461.27
20min12903-29031.4541.428.621.491.468.54
23268-32681.6371.68
32699-26991.3521.39
42834-28341.4201.46
52566-25661.2851.32
62715-27151.3601.40
30min13808-38081.9071.8110.981.961.8610.90
24330-43302.1692.23
33394-33941.7001.75
43431-34311.7191.77
53260-32601.6331.68
63444-34441.7251.78
45min14675-46752.3422.2210.882.422.2910.74
25305-53052.6572.74
34243-42432.1252.20
44119-41192.0632.14
54062-40622.0352.10
64170-41702.0892.16
60min15987-59872.9992.7513.203.102.8513.02
26737-67373.3753.49
35016-50162.5132.61
45164-51642.5872.68
54888-48882.4482.54
65136-51362.5732.67
极限16734-67343.3733.0613.883.513.1813.72
27527-75273.7703.92
35595-55952.8032.92
45783-57832.8973.02
55328-53282.6692.79
65653-56532.8322.95
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%
117.401952941950241949541947871948981949910.10
217.411936171937241936700.04
单位质量响应值RSD%判断
11206.3811124.070.53数据可信
供试品溶液-12461045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%
5min12066-20661.0360.908.581.040.908.71
21686-16860.8450.85
31682-16820.8430.84
41872-18720.9380.94
51676-16760.8400.84
61818-18180.9110.91
10min12592-25921.2991.156.881.311.166.96
22265-22651.1351.14
32241-22411.1231.13
42325-23251.1651.18
52118-21181.0621.07
62261-22611.1331.14
15min12911-29111.4591.287.601.491.307.67
22508-25081.2571.28
32534-25341.2701.29
42590-25901.2981.32
52369-23691.1881.21
62401-24011.2041.23
20min13168-31681.5881.397.451.631.427.52
22651-26511.3291.36
32728-27281.3681.40
42779-27791.3931.43
52588-25881.2971.33
62702-27021.3541.39
30min14088-40882.0491.758.632.111.808.62
23499-34991.7541.80
33291-32911.6501.70
43445-34451.7271.78
53279-32791.6441.69
63380-33801.6941.75
45min15203-52032.6082.1411.082.692.2110.95
24251-42512.1312.20
34123-41232.0672.14
44166-41662.0882.16
53902-39021.9562.02
63985-39851.9982.07
60min16590-65903.3032.6612.253.422.7512.18
25315-53152.6642.76
35014-50142.5132.61
45044-50442.5282.62
54898-48982.4552.54
64935-49352.4742.57
极限17434-74343.7272.9712.803.873.0912.56
25852-58522.9343.06
35604-56042.8092.93
45590-55902.8022.93
55417-54172.7152.83
65597-55972.8062.93
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