美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122617172580922607782608762606472604220.53
218.092615222608222611720.19
单位质量响应值RSD%判断
14372.0814437.370.33数据可信
供试品溶液-24112202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%
5min11066-10660.4140.4819.370.410.4819.50
2945-9450.3670.37
31464-14640.5690.57
41093-10930.4250.42
51548-15480.6010.60
61282-12820.4980.50
10min15380-53802.0902.214.612.092.224.66
25716-57162.2212.22
35886-58862.2872.29
45372-53722.0872.09
55984-59842.3252.33
65831-58312.2662.27
15min18866-88663.4453.523.033.463.532.97
28780-87803.4113.43
39378-93783.6443.66
48913-89133.4633.48
59416-94163.6593.67
68968-89683.4843.50
20min113659-136595.3075.452.765.345.482.73
213703-137035.3245.36
314402-144025.5965.63
413751-137515.3435.38
514560-145605.6575.69
614095-140955.4775.51
30min120075-200757.8007.991.627.868.061.64
220776-207768.0728.14
321058-210588.1828.25
420510-205107.9698.03
520412-204127.9318.00
620539-205397.9808.05
45min132165-3216512.49812.602.1012.6012.712.09
233420-3342012.98513.09
333007-3300712.82512.94
432460-3246012.61212.72
532052-3205212.45412.57
631539-3153912.25412.36
60min143621-4362116.94917.050.9417.1217.220.94
244246-4424617.19217.37
343924-4392417.06717.25
444331-4433117.22517.40
543885-4388517.05117.23
643228-4322816.79616.97
极限148658-4865818.90619.131.2919.1819.401.28
249509-4950919.23719.51
349623-4962319.28119.56
450170-5017019.49319.77
548703-4870318.92319.20
648688-4868818.91819.19
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122629472611792615672618532595922614280.47
218.092605842599392602620.18
单位质量响应值RSD%判断
14427.5914387.060.20数据可信
供试品溶液-24112202批-磷酸盐溶液(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%
5min1538-5380.2091.83135.630.211.84135.61
2544-5440.2110.21
311601-116014.5074.51
4735-7350.2860.29
5674-6740.2620.26
614227-142275.5275.53
10min11303-13030.5060.524.320.510.534.05
21343-13430.5220.52
31253-12530.4870.51
41428-14280.5550.56
51339-13390.5200.52
61345-13450.5220.55
15min11701-17010.6610.672.160.660.692.20
21731-17310.6720.68
31703-17030.6620.69
41797-17970.6980.70
51765-17650.6860.69
61721-17210.6690.70
20min12214-22140.8600.872.170.870.892.80
22201-22010.8550.86
32234-22340.8680.90
42327-23270.9040.91
52208-22080.8580.87
62273-22730.8830.92
30min12901-29011.1271.162.641.141.192.25
23045-30451.1831.20
32958-29581.1491.19
43115-31151.2101.22
53025-30251.1751.19
62938-29381.1411.18
45min14407-44071.7121.671.691.731.701.47
24261-42611.6551.67
34260-42601.6551.70
44379-43791.7011.72
54241-42411.6481.67
64254-42541.6531.70
60min16155-61552.3912.342.912.422.372.77
25915-59152.2982.33
35921-59212.3002.35
46305-63052.4492.48
55858-58582.2762.30
65935-59352.3062.36
极限16934-69342.6942.673.292.742.723.04
26754-67542.6242.66
36856-68562.6632.73
47289-72892.8322.87
56767-67672.6292.67
66647-66472.5822.65
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122604862607152614962617882612832611540.21
218.092610752612902611820.06
单位质量响应值RSD%判断
14412.4714437.920.13数据可信
供试品溶液-24112202批-醋酸盐溶液(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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12434-24340.9440.4986.130.940.4886.10
2545-5450.2110.21
3600-6000.2330.23
42832-28321.0991.10
5562-5620.2180.22
6536-5360.2080.21
15min1574-5740.2230.246.010.230.245.63
2619-6190.2400.24
3686-6860.2660.27
4600-6000.2330.24
5633-6330.2460.25
6614-6140.2380.24
20min1630-6300.2440.265.660.250.264.87
2694-6940.2690.27
3672-6720.2610.26
4597-5970.2320.24
5679-6790.2630.27
6684-6840.2650.27
30min1703-7030.2730.306.820.280.306.81
2753-7530.2920.30
3782-7820.3030.31
4737-7370.2860.29
5771-7710.2990.30
6857-8570.3330.34
45min1738-7380.2860.3010.990.300.3010.36
2741-7410.2880.29
3867-8670.3360.34
4620-6200.2410.25
5806-8060.3130.32
6798-7980.3100.32
60min1761-7610.2950.335.500.310.334.10
2870-8700.3380.34
3892-8920.3460.35
4856-8560.3320.34
5840-8400.3260.33
6819-8190.3180.33
极限1925-9250.3590.363.640.370.373.83
2936-9360.3630.37
3981-9810.3810.39
4941-9410.3650.38
5916-9160.3550.36
6879-8790.3410.35
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
118.122600992593622611442597862592432599270.30
218.092605362608642607000.09
单位质量响应值RSD%判断
14344.7614411.280.33数据可信
供试品溶液-24112202批-pH1.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18301-83013.2313.107.063.233.107.02
27185-71852.7972.80
38539-85393.3243.32
47599-75992.9582.96
57626-76262.9692.97
68494-84943.3063.31
10min1901-9010.3510.364.730.370.374.38
2867-8670.3370.35
3914-9140.3560.37
4912-9120.3550.37
5997-9970.3880.40
6936-9360.3640.38
15min11267-12670.4930.524.770.510.545.12
21291-12910.5030.52
31337-13370.5200.54
41275-12750.4960.51
51372-13720.5340.55
61429-14290.5560.58
20min11602-16020.6240.631.470.650.651.38
21580-15800.6150.64
31589-15890.6190.64
41603-16030.6240.65
51644-16440.6400.66
61626-16260.6330.66
30min12240-22400.8720.871.690.900.901.78
22174-21740.8460.87
32262-22620.8810.91
42267-22670.8820.91
52267-22670.8820.91
62274-22740.8850.91
45min12818-28181.0971.102.221.131.132.06
22811-28111.0941.12
32907-29071.1321.16
42738-27381.0661.10
52766-27661.0771.11
62866-28661.1161.15
60min13339-33391.3001.363.121.341.402.93
23500-35001.3621.40
33562-35621.3871.42
43463-34631.3481.38
53459-34591.3461.38
63662-36621.4261.46
极限13846-38461.4971.629.861.541.669.70
23896-38961.5171.56
34044-40441.5741.62
44113-41131.6011.64
54967-49671.9331.98
64079-40791.5881.63
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