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%
118.002085072088122085032086242086452086180.07
218.042085702086082085890.02
单位质量响应值RSD%判断
11589.8911562.580.17数据可信
供试品溶液-12521473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%
5min14204-42042.0331.987.322.031.987.24
23978-39781.9231.92
34198-41982.0302.03
44256-42562.0582.06
54352-43522.1042.10
63531-35311.7071.71
10min17112-71123.4393.613.563.463.633.51
27353-73533.5553.58
37903-79033.8213.84
47572-75723.6613.68
57508-75083.6303.65
67362-73623.5593.58
15min112209-122095.9035.952.215.966.022.26
212167-121675.8835.94
312577-125776.0816.15
412311-123115.9526.02
512668-126686.1256.19
611939-119395.7725.83
20min115545-155457.5167.562.027.647.692.04
215731-157317.6067.73
315935-159357.7047.84
415949-159497.7117.84
515595-155957.5407.67
615099-150997.3007.42
30min127122-2712213.11313.251.5413.3213.461.54
227824-2782413.45213.66
327659-2765913.37313.59
427733-2773313.40813.62
527317-2731713.20713.42
626733-2673312.92513.13
45min138278-3827818.50718.111.6018.8618.461.57
237379-3737918.07218.43
337463-3746318.11318.48
437783-3778318.26718.63
536463-3646317.62917.99
637322-3732218.04418.39
60min150343-5034324.34024.231.5424.9024.781.53
251193-5119324.75125.31
350175-5017524.25924.83
450497-5049724.41424.98
549260-4926023.81624.37
649177-4917723.77624.32
极限155925-5592527.03926.991.7627.8727.821.75
256514-5651427.32328.16
356751-5675127.43828.28
456138-5613827.14227.98
555651-5565126.90627.73
653997-5399726.10626.92
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%
118.002078362079302080122076462078572078560.07
218.042084532078852081690.20
单位质量响应值RSD%判断
11547.5611539.300.06数据可信
供试品溶液-12521473批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12363-23631.1461.018.361.151.018.34
21998-19980.9690.97
32000-20000.9700.97
41917-19170.9290.93
52215-22151.0741.07
61970-19700.9550.96
10min12683-26831.3011.253.441.311.263.42
22600-26001.2611.27
32547-25471.2351.25
42694-26941.3061.32
52489-24891.2071.22
62499-24991.2121.22
15min13035-30351.4721.491.821.501.511.76
23087-30871.4971.52
33126-31261.5161.54
43127-31271.5161.54
53068-30681.4881.51
62983-29831.4461.47
20min13404-34041.6501.643.321.691.683.21
23314-33141.6071.65
33326-33261.6131.65
43592-35921.7421.78
53355-33551.6271.67
63283-32831.5921.63
30min14344-43442.1062.073.612.172.133.63
24172-41722.0232.08
34150-41502.0122.07
44528-45282.1952.26
54314-43142.0922.15
64125-41252.0002.06
45min15959-59592.8892.853.262.972.933.23
25832-58322.8282.91
35793-57932.8092.89
46197-61973.0053.09
55807-58072.8162.90
65633-56332.7312.81
60min16991-69913.3903.402.353.513.512.32
27103-71033.4443.56
36881-68813.3363.45
47284-72843.5323.65
56861-68613.3273.44
66904-69043.3473.46
极限17727-77273.7463.855.203.904.005.07
27974-79743.8664.02
37582-75823.6763.83
48684-86844.2104.37
58052-80523.9044.06
67607-76073.6883.84
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%
118.002084702082382078712080732081692081640.11
218.042080302079672079980.03
单位质量响应值RSD%判断
11564.6711529.820.22数据可信
供试品溶液-12521473批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1941-9410.4560.468.370.460.468.61
2886-8860.4290.43
3871-8710.4220.42
41084-10840.5250.53
5921-9210.4460.45
6998-9980.4840.48
10min11195-11950.5790.575.000.580.584.77
21100-11000.5330.54
31163-11630.5640.57
41255-12550.6080.61
51122-11220.5440.55
61219-12190.5910.60
15min11364-13640.6610.643.820.670.653.71
21232-12320.5970.61
31297-12970.6290.64
41350-13500.6540.67
51345-13450.6520.66
61353-13530.6560.67
20min11301-13010.6310.645.090.650.665.19
21282-12820.6210.64
31231-12310.5970.61
41411-14110.6840.70
51381-13810.6690.69
61359-13590.6590.68
30min11342-13420.6500.6410.140.680.669.96
21244-12440.6030.63
31176-11760.5700.59
41542-15420.7470.77
51215-12150.5890.61
61366-13660.6620.69
45min11473-14730.7140.734.150.750.764.11
21442-14420.6990.73
31547-15470.7500.78
41599-15990.7750.81
51444-14440.7000.73
61516-15160.7350.77
60min11499-14990.7270.716.770.770.756.76
21331-13310.6450.68
31468-14680.7120.75
41622-16220.7860.83
51398-13980.6780.72
61504-15040.7290.77
极限11530-15300.7420.716.400.790.766.41
21372-13720.6650.71
31386-13860.6720.72
41617-16170.7840.84
51427-14270.6920.74
61491-14910.7230.77
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%
118.002079012074442078982076922076422077150.10
218.042053122052662052890.02
单位质量响应值RSD%判断
11539.7211379.660.99数据可信
供试品溶液-12521473批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11339-13390.6540.714.880.650.715.09
21448-14480.7070.71
31517-15170.7410.74
41453-14530.7100.71
51527-15270.7460.75
61405-14050.6860.69
10min11893-18930.9250.963.920.930.974.05
21955-19550.9550.96
32062-20621.0071.02
41883-18830.9200.93
52005-20050.9790.99
62053-20531.0031.01
15min12291-22911.1191.175.151.141.195.24
22406-24061.1751.19
32592-25921.2661.29
42265-22651.1061.12
52363-23631.1541.17
62487-24871.2151.23
20min12637-26371.2881.303.741.321.343.71
22609-26091.2741.31
32851-28511.3921.43
42590-25901.2651.30
52612-26121.2761.31
62720-27201.3291.36
30min13086-30861.5071.555.061.551.594.94
23489-34891.7041.75
33108-31081.5181.57
43117-31171.5221.57
53128-31281.5281.57
63064-30641.4971.54
45min13657-36571.7861.864.951.851.934.75
23864-38641.8871.95
34068-40681.9872.05
43807-38071.8591.92
53937-39371.9231.99
63548-35481.7331.80
60min14479-44792.1882.202.342.272.282.30
24390-43902.1442.23
34678-46782.2852.37
44521-45212.2082.29
54526-45262.2112.30
64401-44012.1502.23
极限14876-48762.3822.451.962.492.561.96
25042-50422.4632.57
35149-51492.5152.63
44926-49262.4062.51
55043-50432.4632.57
65053-50532.4682.57
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