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)40 供试品稀释倍数2.5 系数0.972
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.262025742026502024702025342014732023400.25
219.292027062019762023410.26
单位质量响应值RSD%判断
10505.7110489.420.11数据可信
供试品溶液-12087013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%
5min11313-13130.6800.625.860.680.626.04
21158-11580.6000.60
31159-11590.6000.60
41126-11260.5830.58
51184-11840.6130.61
61251-12510.6480.65
10min11644-16440.8510.795.540.860.805.69
21479-14790.7660.77
31458-14580.7550.76
41433-14330.7420.75
51542-15420.7980.81
61605-16050.8310.84
15min11839-18390.9520.876.730.970.896.71
21602-16020.8290.84
31604-16040.8300.85
41572-15720.8140.83
51714-17140.8870.90
61802-18020.9330.95
20min11938-19381.0030.945.801.030.975.88
21755-17550.9090.93
31735-17350.8980.92
41703-17030.8820.91
51832-18320.9480.97
61949-19491.0091.04
30min12223-22231.1511.095.041.191.125.06
22018-20181.0451.08
32039-20391.0561.09
41979-19791.0251.06
52141-21411.1081.14
62221-22211.1501.19
45min12445-24451.2661.205.231.321.255.34
22245-22451.1621.21
32260-22601.1701.22
42197-21971.1371.18
52307-23071.1941.24
62503-25031.2961.35
60min12587-25871.3391.284.071.401.344.10
22386-23861.2351.29
32412-24121.2491.31
42374-23741.2291.29
52530-25301.3101.37
62591-25911.3411.41
极限12779-27791.4391.355.561.521.435.54
22517-25171.3031.38
32529-25291.3091.38
42436-24361.2611.33
52622-26221.3571.43
62786-27861.4421.52
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)40 供试品稀释倍数2.5 系数0.972
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.262016492010082014092019672012502014570.19
219.292002091995421998760.24
单位质量响应值RSD%判断
10459.8710361.640.67数据可信
供试品溶液-12087013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%
5min122693-2269311.8472.47186.0311.852.47186.05
21016-10160.5300.53
31096-10960.5720.57
41205-12050.6290.63
51164-11640.6080.61
61210-12100.6320.63
10min11360-13600.7100.734.720.840.766.82
21320-13200.6890.69
31362-13620.7110.72
41470-14700.7670.77
51476-14760.7710.78
61445-14450.7540.76
15min11545-15450.8070.835.520.950.867.17
21443-14430.7530.77
31543-15430.8060.82
41671-16710.8720.89
51654-16540.8630.88
61636-16360.8540.87
20min11643-16430.8580.875.311.010.927.01
21559-15590.8140.84
31588-15880.8290.85
41774-17740.9260.95
51751-17510.9140.94
61718-17180.8970.92
30min11914-19140.9991.024.601.161.085.77
21817-18170.9490.98
31934-19341.0101.04
42049-20491.0701.11
52032-20321.0611.10
62026-20261.0581.09
45min12146-21461.1201.134.021.291.205.39
22039-20391.0641.11
32104-21041.0981.14
42274-22741.1871.23
52223-22231.1601.21
62214-22141.1561.20
60min12319-23191.2111.224.031.391.295.38
22182-21821.1391.19
32278-22781.1891.25
42454-24541.2811.34
52364-23641.2341.29
62381-23811.2431.30
极限12439-24391.2731.283.921.471.385.30
22296-22961.1991.26
32418-24181.2621.33
42575-25751.3441.42
52513-25131.3121.39
62497-24971.3041.38
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)40 供试品稀释倍数2.5 系数0.972
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.262026312024882024632023872017202023380.18
219.292008642011622010130.11
单位质量响应值RSD%判断
10505.6110420.580.58数据可信
供试品溶液-12087013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%
5min11793-17930.9311.1114.070.931.1113.96
22373-23731.2331.23
31791-17910.9300.93
42149-21491.1161.12
52530-25301.3141.31
62161-21611.1221.12
10min13452-34521.7931.686.201.801.706.11
23185-31851.6541.67
32886-28861.4991.51
43246-32461.6861.70
53284-32841.7061.72
63402-34021.7671.78
15min13773-37731.9601.856.071.991.886.00
23488-34881.8121.84
33175-31751.6491.68
43547-35471.8421.87
53623-36231.8821.92
63732-37321.9381.97
20min14081-40812.1202.005.382.172.055.30
23738-37381.9421.99
33509-35091.8231.87
43873-38732.0122.06
53879-38792.0152.07
64025-40252.0912.14
30min15201-52012.7022.644.472.782.724.53
24947-49472.5702.64
34739-47392.4622.53
45031-50312.6132.69
55316-53162.7612.84
65312-53122.7592.84
45min16459-64593.3553.204.673.463.304.60
26110-61103.1743.28
35649-56492.9343.03
46311-63113.2783.38
56110-61103.1743.28
66345-63453.2963.40
60min17333-73333.8093.673.943.953.813.90
26868-68683.5673.71
36607-66073.4323.56
47164-71643.7213.86
57176-71763.7273.87
67276-72763.7793.92
极限18119-81194.2174.053.414.404.233.41
27812-78124.0584.23
37348-73483.8173.98
47890-78904.0984.28
57946-79464.1274.31
67665-76653.9814.17
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)40 供试品稀释倍数2.5 系数0.972
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.261993501989071993311991371985251990500.18
219.291996901990481993690.23
单位质量响应值RSD%判断
10334.8910335.360.01数据可信
供试品溶液-12087013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%
5min12130-21301.1201.228.711.121.228.80
22444-24441.2851.29
32245-22451.1811.18
42112-21121.1111.11
52344-23441.2331.23
62642-26421.3891.39
10min13374-33741.7741.703.691.791.723.70
23316-33161.7441.76
33127-31271.6441.66
43110-31101.6351.65
53163-31631.6631.68
63347-33471.7601.78
15min13628-36281.9081.863.081.941.893.21
23608-36081.8971.93
33455-34551.8171.85
43374-33741.7741.80
53479-34791.8291.86
63633-36331.9101.95
20min14002-40022.1042.003.452.162.063.54
23745-37451.9692.02
33761-37611.9782.03
43638-36381.9131.96
53785-37851.9902.04
63924-39242.0632.12
30min15269-52692.7712.682.352.852.762.39
25232-52322.7512.83
35002-50022.6302.70
45012-50122.6362.71
55026-50262.6432.72
65047-50472.6542.73
45min16395-63953.3633.252.433.473.362.47
26200-62003.2603.37
36178-61783.2493.35
45990-59903.1503.25
56049-60493.1813.28
66292-62923.3093.42
60min17360-73603.8703.855.934.023.995.65
27098-70983.7323.88
37451-74513.9184.06
48097-80974.2584.39
56951-69513.6553.79
66956-69563.6583.80
极限18151-81514.2864.162.354.474.352.23
28050-80504.2334.42
37859-78594.1334.32
47873-78734.1404.32
57948-79484.1794.36
67610-76104.0024.19
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