氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011457213145783114571641457030145686914572210.03
210.721429267142983914295530.03
单位质量响应值RSD%判断
132354.31133353.820.54数据可信
供试品溶液-24032901批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min187050-870505.8106.012.545.816.012.53
291709-917096.1216.12
391083-910836.0796.08
490074-900746.0116.01
587850-878505.8635.86
692953-929536.2046.20
120min1327946-32794621.88723.505.5521.9023.505.54
2370529-37052924.72924.74
3344895-34489523.01823.03
4335791-33579122.41022.42
5355490-35549023.72523.73
6377606-37760625.20125.21
240min1752442-75244250.21751.395.1550.2651.435.14
2769662-76966251.36751.41
3799656-79965653.36853.41
4699842-69984246.70746.75
5802007-80200753.52553.57
6796423-79642353.15353.20
360min11207815-120781580.60979.635.2380.7379.765.22
21156877-115687777.20977.33
31227196-122719681.90282.03
41084653-108465372.38972.50
51253639-125363983.66783.79
61228971-122897182.02182.15
480min11513395-1513395101.003101.791.57101.24102.041.56
21516474-1516474101.208101.45
31573506-1573506105.015105.26
41516619-1516619101.218101.44
51511820-1511820100.898101.15
61519577-1519577101.416101.67
720min11556050-1556050103.850104.180.48104.24104.570.48
21570137-1570137104.790105.18
31566717-1566717104.562104.97
41561583-1561583104.219104.59
51549217-1549217103.394103.80
61561919-1561919104.241104.64
960min11541954-1541954102.909103.150.27103.45103.700.27
21552293-1552293103.599104.15
31546410-1546410103.206103.77
41547061-1547061103.250103.78
51540942-1540942102.841103.40
61544843-1544843103.102103.66
1200min11525521-1525521101.812102.150.58102.51102.850.58
21546650-1546650103.222103.93
31532280-1532280102.263102.98
41527431-1527431101.940102.62
51520755-1520755101.494102.20
61530609-1530609102.152102.86
1440min11518496-1518496101.343101.550.35102.20102.400.35
21529173-1529173102.056102.91
31525733-1525733101.826102.70
41518941-1518941101.373102.21
51514998-1514998101.110101.97
61521904-1521904101.571102.44
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11514832-1514832101.099101.350.38102.10102.360.38
21522888-1522888101.636102.65
31524951-1524951101.774102.80
41522577-1522577101.616102.60
51510445-1510445100.806101.82
61515483-1515483101.142102.16
氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011461296146047014607231460259146005114605600.04
210.721426870142809514274820.07
单位质量响应值RSD%判断
132657.58133160.630.27数据可信
供试品溶液-24032901批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min136958-369582.4662.267.532.472.267.55
232441-324412.1642.16
336187-361872.4142.41
433023-330232.2032.20
534556-345562.3052.31
630084-300842.0072.01
120min1159203-15920310.62110.321.7810.6210.321.77
2150906-15090610.06710.07
3154642-15464210.31610.32
4154230-15423010.28910.29
5155702-15570210.38710.39
6153329-15332910.22910.23
240min1290455-29045519.37719.582.3519.4019.602.35
2286396-28639619.10619.12
3286577-28657719.11819.14
4303836-30383620.26920.29
5297787-29778719.86619.88
6295718-29571819.72819.75
360min1410593-41059327.39128.043.3427.4428.083.34
2408689-40868927.26427.31
3417470-41747027.85027.90
4447476-44747629.85229.90
5419894-41989428.01228.06
6417552-41755227.85527.90
480min1517656-51765634.53335.382.7934.6235.472.79
2522309-52230934.84434.93
3529444-52944435.32035.41
4559066-55906637.29637.39
5529550-52955035.32735.42
6523942-52394234.95335.04
720min1710883-71088347.42449.523.1747.5749.663.16
2759707-75970750.68150.82
3739229-73922949.31549.46
4777555-77755551.87152.02
5738303-73830349.25349.40
6728237-72823748.58148.72
960min1882210-88221058.85363.054.3759.0763.274.36
2994562-99456266.34866.56
3942619-94261962.88363.10
4986281-98628165.79666.02
5939169-93916962.65362.87
6925869-92586961.76661.98
1200min11147590-114759076.55785.657.7076.8685.967.68
21414298-141429894.34994.66
31281766-128176685.50885.82
41376929-137692991.85692.18
51263615-126361584.29784.61
61219399-121939981.34781.65
1440min11379123-137912392.00397.393.3492.4297.833.34
21500947-1500947100.130100.59
31463285-146328597.61798.06
41495925-149592599.795100.26
51494206-149420699.680100.12
61425593-142559395.10395.53
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11434282-143428295.68299.022.0196.2499.612.02
21515944-1515944101.130101.74
31474409-147440998.35998.94
41505212-1505212100.414101.03
51501757-1501757100.184100.77
61474562-147456298.36998.94
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