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%
118.152104212104172103342104932103532104040.03
218.172099442094202096820.18
单位质量响应值RSD%判断
11592.5111540.010.33数据可信
供试品溶液-12564941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%
5min12965-29651.4351.7217.721.431.7217.79
24714-47142.2812.28
33663-36631.7731.77
43061-30611.4811.48
53500-35001.6941.69
63390-33901.6401.64
10min16650-66503.2183.292.283.233.312.37
27042-70423.4083.43
36823-68233.3023.32
46710-67103.2473.26
56927-69273.3523.37
66683-66833.2343.25
15min110608-106085.1335.132.555.185.182.58
211095-110955.3695.43
310600-106005.1295.19
410353-103535.0105.06
510361-103615.0145.07
610590-105905.1245.18
20min114287-142876.9136.991.617.027.101.62
214695-146957.1117.23
314675-146757.1017.21
414340-143406.9397.05
514554-145547.0437.15
614119-141196.8326.94
30min124083-2408311.65411.842.5711.8412.032.58
225139-2513912.16512.37
324666-2466611.93612.13
424046-2404611.63611.82
525214-2521412.20112.39
623699-2369911.46811.65
45min136602-3660217.71218.282.0418.0318.602.04
238832-3883218.79119.13
337586-3758618.18818.51
437475-3747518.13418.45
538343-3834318.55418.88
637810-3781018.29618.61
60min148231-4823123.33923.051.5023.8523.571.49
248278-4827823.36223.91
348282-4828223.36423.89
447187-4718722.83423.35
547056-4705622.77023.30
646738-4673822.61623.13
极限152863-5286325.58025.681.3326.3526.461.31
253275-5327525.78026.59
353247-5324725.76626.55
453254-5325425.77026.54
553975-5397526.11826.90
651850-5185025.09025.86
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%
118.152103162103802099072100872100722101520.10
218.172071952069542070740.09
单位质量响应值RSD%判断
11578.6211396.481.13数据可信
供试品溶液-12564941批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12476-24761.2061.167.491.211.167.41
22186-21861.0651.07
32672-26721.3021.30
42448-24481.1931.19
52283-22831.1121.11
62263-22631.1031.10
10min12953-29531.4391.325.441.451.335.37
22523-25231.2291.24
32629-26291.2811.30
42776-27761.3531.37
52678-26781.3051.32
62671-26711.3011.31
15min13163-31631.5411.454.471.571.484.45
22779-27791.3541.38
32957-29571.4411.47
42982-29821.4531.48
53079-30791.5001.53
62915-29151.4201.45
20min13511-35111.7111.643.381.761.693.48
23165-31651.5421.58
33403-34031.6581.70
43384-33841.6491.69
53408-34081.6611.70
63378-33781.6461.69
30min13844-38441.8731.861.651.941.921.70
23750-37501.8271.88
33858-38581.8801.94
43921-39211.9101.97
53772-37721.8381.90
63795-37951.8491.91
45min14863-48632.3692.404.582.462.484.43
24695-46952.2882.37
34916-49162.3952.48
45000-50002.4362.52
55334-53342.5992.68
64768-47682.3232.40
60min15903-59032.8762.832.672.992.942.56
25840-58402.8452.95
36029-60292.9383.05
45811-58112.8312.94
55595-55952.7262.84
65683-56832.7692.88
极限16322-63223.0803.111.593.223.251.51
26360-63603.0993.23
36571-65713.2023.34
46448-64483.1423.28
56357-63573.0973.24
66299-62993.0693.21
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%
118.152102232101992101042101312100912101500.03
218.172092272090872091570.05
单位质量响应值RSD%判断
11578.5111511.120.42数据可信
供试品溶液-12564941批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1883-8830.4280.4810.760.430.4810.78
2983-9830.4770.48
3885-8850.4290.43
41172-11720.5680.57
51014-10140.4920.49
6977-9770.4740.47
10min11116-11160.5410.574.040.550.583.78
21222-12220.5920.60
31161-11610.5630.57
41176-11760.5700.58
51172-11720.5680.57
61253-12530.6070.61
15min11124-11240.5450.617.370.560.627.21
21235-12350.5990.61
31186-11860.5750.59
41329-13290.6440.66
51327-13270.6430.66
61357-13570.6580.67
20min11209-12090.5860.607.510.600.627.52
21176-11760.5700.59
31114-11140.5400.56
41223-12230.5930.61
51378-13780.6680.69
61293-12930.6270.65
30min11291-12910.6260.642.700.650.662.65
21338-13380.6490.67
31269-12690.6150.64
41326-13260.6430.67
51323-13230.6410.67
61369-13690.6640.69
45min11334-13340.6470.675.160.680.705.00
21339-13390.6490.68
31308-13080.6340.66
41381-13810.6700.70
51400-14000.6790.71
61506-15060.7300.76
60min11116-11160.5410.7222.170.580.7621.11
21393-13930.6750.71
32106-21061.0211.06
41469-14690.7120.75
51368-13680.6630.70
61483-14830.7190.76
极限11404-14040.6810.746.170.720.796.10
21453-14530.7040.75
31640-16400.7950.84
41499-14990.7270.78
51609-16090.7800.83
61591-15910.7710.82
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%
118.152090602091922086592088782086082088790.13
218.172071212075002073100.13
单位质量响应值RSD%判断
11508.4811409.470.62数据可信
供试品溶液-12564941批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11398-13980.6830.635.730.680.635.59
21307-13070.6380.64
31204-12040.5880.59
41323-13230.6460.65
51208-12080.5900.59
61295-12950.6330.63
10min11750-17500.8550.852.750.860.862.66
21830-18300.8940.90
31778-17780.8680.87
41722-17220.8410.85
51702-17020.8310.84
61715-17150.8380.84
15min11969-19690.9621.003.480.981.023.37
22174-21741.0621.08
32005-20050.9791.00
42073-20731.0131.03
52027-20270.9901.01
62033-20330.9931.01
20min12308-23081.1271.102.891.161.122.91
22180-21801.0651.09
32168-21681.0591.09
42315-23151.1311.16
52220-22201.0841.11
62283-22831.1151.14
30min12541-25411.2411.211.331.281.251.24
22454-24541.1991.24
32462-24621.2031.24
42455-24551.1991.24
52470-24701.2061.25
62484-24841.2131.25
45min12667-26671.3031.374.281.361.424.04
22825-28251.3801.43
32736-27361.3361.39
42796-27961.3661.42
52800-28001.3681.42
63023-30231.4771.53
60min13105-31051.5171.563.481.591.633.33
23212-32121.5691.64
33182-31821.5541.62
43023-30231.4771.55
53274-32741.5991.67
63328-33281.6261.70
极限13557-35571.7371.653.461.821.733.34
23375-33751.6481.74
33370-33701.6461.73
43193-31931.5601.64
53338-33381.6301.72
63405-34051.6631.75
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