沙库巴曲缬沙坦片项目信息
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%
127.931135667113649311376731135141113541911360790.10
228.051144105114342711437660.05
单位质量响应值RSD%判断
40675.9440775.970.18数据可信
供试品溶液-TYN28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%
5min1122701-1227014.8804.6812.274.884.6812.30
2113146-1131464.5004.50
3115719-1157194.6024.60
493055-930553.7013.70
5127274-1272745.0615.06
6134911-1349115.3655.37
10min1381477-38147715.17114.706.1015.1814.716.11
2360276-36027614.32814.34
3390294-39029415.52115.53
4328827-32882713.07713.08
5373544-37354414.85514.86
6383949-38394915.26915.28
15min1598238-59823823.79123.584.3923.8223.614.39
2569711-56971122.65622.69
3638759-63875925.40225.44
4569449-56944922.64622.67
5582177-58217723.15223.19
6599412-59941223.83823.87
20min1786754-78675431.28831.504.6531.3631.574.65
2764826-76482630.41630.48
3864897-86489734.39534.47
4774548-77454830.80230.87
5772576-77257630.72430.80
6789220-78922031.38631.46
30min11056366-105636642.01042.471.4542.1442.601.45
21065474-106547442.37242.49
31092001-109200143.42743.56
41061321-106132142.20742.32
51051896-105189641.83241.96
61080947-108094742.98743.11
45min11178030-117803046.84846.631.9947.0446.831.99
21207757-120775748.03048.22
31168861-116886146.48446.69
41151911-115191145.81046.00
51143672-114367245.48245.67
61185568-118556847.14847.35
60min11218170-121817048.44548.122.5048.7248.402.49
21258155-125815550.03550.31
31198229-119822947.65247.93
41184457-118445747.10447.37
51176236-117623646.77747.05
61225495-122549548.73649.01
极限11262541-126254150.20949.462.5350.5649.822.52
21289575-128957551.28451.64
31229301-122930148.88749.25
41212166-121216648.20648.55
51211106-121110648.16448.51
61258171-125817150.03550.39
沙库巴曲缬沙坦片项目信息
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%
127.931979720198238119831001983421198214319821530.08
228.051993885198989019918880.15
单位质量响应值RSD%判断
70968.6071012.050.05数据可信
供试品溶液-TYN28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%
5min1157239-1572393.3893.2710.873.393.2710.97
2145900-1459003.1453.14
3147148-1471483.1723.17
4124539-1245392.6842.68
5163682-1636823.5283.53
6171479-1714793.6963.70
10min1511910-51191011.03410.666.4911.0410.676.47
2482490-48249010.40010.41
3522367-52236711.25911.26
4435814-4358149.3949.40
5500192-50019210.78110.79
6515615-51561511.11411.12
15min1824026-82402617.76217.714.2717.7917.744.28
2790137-79013717.03117.05
3883633-88363319.04619.07
4788838-78883817.00317.02
5811157-81115717.48417.51
6832913-83291317.95317.98
20min11108802-110880223.90024.254.5123.9524.304.52
21086135-108613523.41123.46
31225886-122588626.42326.48
41107269-110726923.86723.92
51100456-110045623.72023.77
61122430-112243024.19324.25
30min11534944-153494433.08533.821.7133.1833.911.71
21561704-156170433.66233.75
31609985-160998534.70234.80
41573813-157381333.92334.01
51548374-154837433.37433.47
61584324-158432434.14934.24
45min11805262-180526238.91238.921.7939.0639.071.79
21855955-185595540.00440.15
31793475-179347538.65838.82
41790589-179058938.59538.74
51762127-176212737.98238.13
61826252-182625239.36439.52
60min11912774-191277441.22941.072.2141.4441.292.20
21973787-197378742.54442.76
31880632-188063240.53640.76
41882834-188283440.58440.79
51855496-185549639.99440.21
61928066-192806641.55941.78
极限12052634-205263444.24443.782.3844.5344.062.37
22106335-210633545.40145.68
32003477-200347743.18443.47
41989096-198909642.87443.15
51981386-198138642.70842.99
62054340-205434044.28044.57
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