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%
118.002075122077892080792077092078262077830.10
218.042087242087082087160.01
单位质量响应值RSD%判断
11543.5011569.620.16数据可信
供试品溶液-12521472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%
5min14159-41592.0142.021.582.012.021.49
24191-41912.0302.03
34240-42402.0532.05
44064-40641.9681.97
54243-42432.0552.05
64174-41742.0212.02
10min17496-74963.6303.702.573.653.722.50
27994-79943.8723.89
37696-76963.7273.75
47546-75463.6553.68
57463-74633.6143.64
67596-75963.6793.70
15min112975-129756.2847.4140.366.357.4840.03
227907-2790713.51513.58
313119-131196.3546.42
412599-125996.1026.16
512790-127906.1946.26
612448-124486.0296.09
20min116190-161907.8417.881.317.978.021.38
216303-163037.8968.11
316133-161337.8137.95
416668-166688.0728.20
516188-161887.8407.97
616080-160807.7887.92
30min127661-2766113.39613.371.2913.6213.611.48
228186-2818613.65113.95
327385-2738513.26313.48
427598-2759813.36613.59
527730-2773013.43013.65
627127-2712713.13813.35
45min137167-3716718.00017.831.2818.3718.211.29
236918-3691817.88018.33
336632-3663217.74118.11
436639-3663917.74418.11
537444-3744418.13418.50
636102-3610217.48417.85
60min148282-4828223.38323.081.1123.9523.661.10
247608-4760823.05723.71
347880-4788023.18823.75
447051-4705122.78723.35
548064-4806423.27823.85
647017-4701722.77023.33
极限152385-5238525.37025.921.3626.2026.761.41
254508-5450826.39827.31
353755-5375526.03426.86
453579-5357925.94826.77
553860-5386026.08526.91
653093-5309325.71326.52
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%
118.002080262075362077842078152077722077870.09
218.042069332072652070990.12
单位质量响应值RSD%判断
11543.7211479.990.40数据可信
供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12252-22521.0951.165.331.091.165.48
22341-23411.1381.14
32626-26261.2771.28
42360-23601.1471.15
52340-23401.1381.14
62377-23771.1561.16
10min12717-27171.3211.275.231.331.285.14
22687-26871.3061.32
32706-27061.3161.33
42702-27021.3141.33
52441-24411.1871.20
62438-24381.1851.20
15min12902-29021.4112.75116.971.442.78115.75
23106-31061.5101.54
33108-31081.5111.54
42908-29081.4141.44
519129-191299.3009.33
62734-27341.3291.36
20min13332-33321.6201.657.641.661.717.72
23890-38901.8911.94
33267-32671.5881.63
43408-34081.6571.70
53349-33491.6281.76
63132-31321.5231.56
30min14309-43092.0952.113.642.162.183.55
24481-44812.1792.24
34532-45322.2032.27
44326-43262.1032.16
54227-42272.0552.20
64107-41071.9972.05
45min15258-52582.5562.591.912.642.692.43
25438-54382.6442.73
35468-54682.6582.75
45230-52302.5432.63
55338-53382.5952.77
65253-52532.5542.63
60min16828-68283.3203.304.503.433.433.63
27096-70963.4503.57
37077-70773.4413.56
46782-67823.2973.41
56276-62763.0513.25
66640-66403.2283.34
极限17435-74353.6153.702.133.763.862.01
27747-77473.7663.92
37850-78503.8173.97
47503-75033.6483.80
57502-75023.6473.88
67605-76053.6973.84
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%
118.002078202076672075882075342074342076090.08
218.042068892068282068580.03
单位质量响应值RSD%判断
11533.8311466.630.42数据可信
供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1599-5990.2920.3711.680.290.3611.85
2789-7890.3840.38
3694-6940.3380.34
4790-7900.3840.38
5837-8370.4070.41
6799-7990.3890.39
10min11141-11410.5550.556.600.560.566.75
21063-10630.5170.52
31278-12780.6220.63
41115-11150.5430.55
51100-11000.5350.54
61111-11110.5410.55
15min11434-14340.6980.7633.590.710.7733.42
21329-13290.6470.66
32601-26011.2661.28
41221-12210.5940.60
51612-16120.7850.79
61216-12160.5920.60
20min11319-13190.6420.635.750.660.645.87
21260-12600.6130.63
31412-14120.6870.71
41213-12130.5900.61
51305-13050.6350.65
61223-12230.5950.61
30min11453-14530.7070.688.740.730.708.80
21564-15640.7610.79
31450-14500.7060.74
41377-13770.6700.69
51242-12420.6040.63
61271-12710.6190.64
45min11439-14390.7000.715.120.730.755.11
21562-15620.7600.79
31539-15390.7490.79
41473-14730.7170.75
51444-14440.7030.74
61354-13540.6590.69
60min11487-14870.7240.734.610.760.775.08
21454-14540.7080.75
31637-16370.7970.85
41496-14960.7280.77
51466-14660.7130.75
61460-14600.7110.75
极限11526-15260.7430.746.250.790.796.32
21441-14410.7010.75
31694-16940.8240.88
41512-15120.7360.78
51428-14280.6950.74
61509-15090.7340.78
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%
118.002079422080122075992079012074182077740.13
218.042065502068022066760.09
单位质量响应值RSD%判断
11543.0011456.540.54数据可信
供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11318-13180.6410.705.520.640.705.57
21377-13770.6700.67
31469-14690.7150.71
41536-15360.7480.75
51461-14610.7110.71
61482-14820.7210.72
10min11845-18450.8980.924.960.910.935.05
21888-18880.9190.93
32070-20701.0071.02
41826-18260.8890.90
51814-18140.8830.89
61896-18960.9230.93
15min12210-22101.0761.128.201.091.148.09
22115-21151.0291.05
32649-26491.2891.31
42194-21941.0681.09
52338-23381.1381.16
62356-23561.1471.16
20min12572-25721.2521.254.221.281.284.06
22400-24001.1681.20
32611-26111.2711.30
42622-26221.2761.31
52498-24981.2161.25
62713-27131.3201.35
30min12959-29591.4401.5913.081.481.6412.71
24121-41212.0062.05
33061-30611.4901.54
43216-32161.5651.61
53129-31291.5231.57
63114-31141.5161.56
45min13786-37861.8431.861.191.901.921.22
23882-38821.8891.95
33855-38551.8761.94
43794-37941.8471.91
53767-37671.8331.89
63787-37871.8431.91
60min14470-44702.1762.175.492.252.255.40
24177-41772.0332.12
34625-46252.2512.34
44463-44632.1722.25
54175-41752.0322.11
64792-47922.3322.42
极限14698-46982.2872.333.262.392.433.18
24742-47422.3082.42
34909-49092.3892.50
44704-47042.2892.40
54599-45992.2382.34
65020-50202.4432.55
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