沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 27.675757185749725751945751655750605752220.06
2 27.675804025783445793730.26
单位质量响应值RSD%判断
20788.6520938.670.51数据可信
供试品溶液-2024032521批-缬沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12877-28770.2230.2118.090.220.2116.95
22451-24510.1900.19
32130-21300.1650.17
43273-32730.2540.25
52176-21760.1690.17
63085-30850.2390.24
10min13492-34920.2710.75121.120.270.75121.47
213657-136571.0601.06
32318-23180.1800.18
431770-317702.4662.47
52764-27640.2150.21
63738-37380.2900.29
15min14260-42600.3311.29120.940.331.29120.81
244930-449303.4883.49
32895-28950.2250.23
439835-398353.0923.10
53307-33070.2570.26
64260-42600.3310.33
20min15782-57820.4492.38151.770.452.39151.71
2120309-1203099.3399.35
33879-38790.3010.30
444216-442163.4323.44
54640-46400.3600.36
65486-54860.4260.43
30min17407-74070.5753.67126.500.583.68126.50
2159943-15994312.41612.44
34930-49300.3830.38
447952-479523.7223.74
56180-61800.4800.48
657081-570814.4314.43
45min1157870-15787012.2557.9349.9712.267.9449.97
2174803-17480313.57013.61
380264-802646.2316.23
454081-540814.1984.22
565134-651345.0565.06
680486-804866.2486.26
60min1188457-18845714.6309.0547.6614.659.0847.65
2184910-18491014.35414.42
395637-956377.4247.44
461249-612494.7554.78
579912-799126.2036.21
689248-892486.9286.95
90min1208365-20836516.17510.1245.8816.2210.1645.88
2202280-20228015.70315.79
3107680-1076808.3598.38
466899-668995.1935.23
595082-950827.3817.40
6101601-1016017.8877.92
120min1221383-22138317.18610.9243.9517.2610.9843.94
2214766-21476616.67216.79
3116812-1168129.0689.11
473828-738285.7315.78
5105971-1059718.2268.26
6111355-1113558.6448.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1292204-29220422.68319.7211.4022.7919.8011.50
2277633-27763321.55221.70
3245459-24545919.05519.11
4208959-20895916.22116.28
5245676-24567619.07219.12
6254061-25406119.72219.78
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 27.679882679874069880499877149869769876820.06
2 27.679940869906549923700.25
单位质量响应值RSD%判断
35695.0535864.470.34数据可信
供试品溶液-2024032521批-沙库巴曲-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14419-44190.1890.1819.620.190.1819.88
24050-40500.1730.17
33236-32360.1380.14
45378-53780.2300.23
53342-33420.1430.14
64683-46830.2000.20
10min15634-56340.2410.74128.570.240.74128.67
224479-244791.0471.05
33773-37730.1610.16
460139-601392.5722.57
54386-43860.1880.19
65952-59520.2550.25
15min17016-70160.3001.30124.380.301.30124.62
283557-835573.5733.58
34676-46760.2000.20
474228-742283.1743.18
55473-54730.2340.23
67094-70940.3030.30
20min19352-93520.4002.41155.680.402.41155.50
2225037-2250379.6249.63
36496-64960.2780.28
480119-801193.4263.44
57672-76720.3280.33
68839-88390.3780.38
30min110942-109420.4683.67129.430.473.68129.38
2294705-29470512.60312.63
37423-74230.3170.32
484805-848053.6273.64
59447-94470.4040.41
6107629-1076294.6034.60
45min1292560-29256012.5128.0250.2012.518.0450.18
2318561-31856113.62413.67
3150437-1504376.4346.44
493301-933013.9904.01
5120999-1209995.1755.18
6149614-1496146.3986.41
60min1346684-34668414.8269.0448.5414.859.0648.54
2332730-33273014.23014.30
3176536-1765367.5507.56
4103181-1031814.4134.44
5145655-1456556.2296.24
6163183-1631836.9797.00
90min1378128-37812816.1719.9047.4016.229.9547.38
2358101-35810115.31515.41
3194783-1947838.3308.36
4110424-1104244.7224.76
5167527-1675277.1657.19
6180486-1804867.7197.75
120min1398998-39899817.06410.5746.0117.1410.6346.03
2377866-37786616.16016.28
3208479-2084798.9168.95
4120044-1200445.1345.18
5183340-1833407.8417.87
6194281-1942818.3098.35
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1512733-51273321.92818.8812.3622.0318.9612.45
2483974-48397420.69820.84
3429960-42996018.38818.44
4354141-35414115.14515.20
5426194-42619418.22718.27
6442385-44238518.91918.98
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