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对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071154593115456911545131153349115336911540790.06
227.991165765116514011654520.04
单位质量响应值RSD%判断
41114.3241638.160.90数据可信
供试品溶液-24110701批-缬沙坦-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%
5min184862-848623.5813.5542.693.583.5542.70
258203-582032.4562.46
356682-566822.3922.39
4154013-1540136.4996.50
576622-766223.2333.23
674711-747113.1533.15
10min1461134-46113419.45916.3320.8119.4716.3420.83
2361116-36111615.23915.24
3294529-29452912.42912.43
4500132-50013221.10521.12
5316835-31683513.37013.38
6388739-38873916.40416.41
15min1733322-73332230.94528.1811.9930.9828.2211.99
2696922-69692229.40929.44
3608652-60865225.68425.71
4754200-75420031.82631.87
5541722-54172222.86022.89
6672496-67249628.37828.41
20min1935348-93534839.47037.874.8039.5637.954.81
2953591-95359140.24040.32
3842063-84206335.53435.60
4903724-90372438.13638.23
5858356-85835636.22136.29
6891755-89175537.63137.71
30min11128848-112884847.63645.214.8747.7945.354.89
21071275-107127545.20645.35
31040134-104013443.89244.02
41119434-111943447.23847.40
5988094-98809441.69641.82
61079945-107994545.57245.71
45min11206527-120652750.91448.434.3651.1548.654.37
21150423-115042348.54648.77
31121336-112133647.31947.52
41187453-118745350.10950.35
51065901-106590144.97945.18
61154002-115400248.69748.92
60min11247228-124722852.63150.323.3952.9550.623.41
21196792-119679250.50350.80
31163400-116340049.09449.37
41224617-122461751.67752.00
51135505-113550547.91748.19
61187421-118742150.10750.41
极限11276388-127638853.86252.742.1154.2753.122.12
21238400-123840052.25952.64
31204679-120467950.83651.20
41266848-126684853.45953.87
51266819-126681953.45853.81
61245366-124536652.55352.94
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对照品来源自制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5.54
标示量(mg)200供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071989840198959519889291987502198691019885550.07
227.992007992200787320079320.01
单位质量响应值RSD%判断
70842.7171737.480.89数据可信
供试品溶液-24110701批-沙库巴曲-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%
5min1100415-10041552.42653.5945.8852.4353.5945.87
266486-6648634.71234.71
368028-6802835.51735.52
4194184-194184101.381101.38
596660-9666050.46550.47
690059-9005947.01947.02
10min1625085-625085326.350270.1322.32326.44270.2222.32
2473988-473988247.464247.52
3392488-392488204.913204.97
4683824-683824357.017357.19
5418389-418389218.436218.52
6510684-510684266.622266.70
15min11020771-1020771532.933477.8212.98533.56478.3612.99
2937472-937472489.443489.91
3822662-822662429.502429.90
41057757-1057757552.243553.01
5741970-741970387.374387.82
6910632-910632475.431475.95
20min11333277-1333277696.089655.625.32697.61656.955.34
21300108-1300108678.772680.06
31160512-1160512605.890607.01
41301877-1301877679.695681.38
51203714-1203714628.445629.54
61235054-1235054644.808646.12
30min11672761-1672761873.329815.905.62876.01818.325.64
21542506-1542506805.325807.74
31499271-1499271782.752784.88
41661041-1661041867.210870.03
51452557-1452557758.363760.50
61548380-1548380808.391810.78
45min11866378-1866378974.415909.935.16978.55913.725.17
21735892-1735892906.289910.05
31694039-1694039884.438887.87
41828134-1828134954.448958.71
51623407-1623407847.562850.97
61709321-1709321892.417896.15
60min11988054-19880541037.940972.644.551043.70977.954.56
21863552-1863552972.939978.21
31815011-1815011947.596952.50
41937454-19374541011.5231017.38
51767830-1767830922.964927.78
61806031-1806031942.908948.13
极限12095083-20950831093.8191057.272.781101.311064.202.79
21994459-19944591041.2841048.18
31950220-19502201018.1881024.67
42075674-20756741083.6861091.22
52046411-20464111068.4081074.76
61988662-19886621038.2581045.05
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