氟伐他汀钠缓释片项目信息
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%
110.741418821141239514126391412377141256814137600.21
211.231475980147641514761980.03
单位质量响应值RSD%判断
131635.01131451.290.10数据可信
供试品溶液-X0731批-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%
240min1174986-17498611.79514.0515.0111.7914.0615.02
2183695-18369512.38212.38
3242834-24283416.36816.37
4221771-22177114.94814.95
5184341-18434112.42512.43
6243433-24343316.40816.41
480min1318615-31861521.47625.4213.2121.4925.4413.21
2335817-33581722.63522.65
3424004-42400428.57928.60
4399254-39925426.91126.93
5347035-34703523.39123.41
6437696-43769629.50229.53
720min1475109-47510932.02435.178.4532.0735.238.46
2481623-48162332.46332.52
3542161-54216136.54436.61
4565318-56531838.10438.17
5492481-49248133.19533.25
6574261-57426138.70738.78
1440min1785361-78536152.93660.3214.1453.0360.4414.12
21000247-100024767.42067.52
3822283-82228355.42555.55
41082117-108211772.93873.06
5767337-76733751.72151.82
6912525-91252561.50761.63
极限1890243-89024360.00567.8211.7460.1868.0211.74
21096908-109690873.93574.14
3970410-97041065.40965.61
41155077-115507777.85678.09
5860346-86034657.99058.17
61063971-106397171.71571.93
氟伐他汀钠缓释片项目信息
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%
110.741404836140369814096511410816141035114078700.24
211.231486940148463514857880.11
单位质量响应值RSD%判断
131086.59132305.250.66数据可信
供试品溶液-X0731批-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%
240min1229889-22988915.47813.299.9315.4813.299.93
2212654-21265414.31714.32
3183113-18311312.32812.33
4181767-18176712.23812.24
5185607-18560712.49612.50
6191022-19102212.86112.86
480min1408435-40843527.49923.928.6627.5223.948.67
2374664-37466425.22525.25
3325773-32577321.93321.95
4336206-33620622.63622.65
5344384-34438423.18623.20
6342127-34212723.03423.05
720min1535324-53532436.04233.255.5836.1133.305.59
2513990-51399034.60534.66
3457150-45715030.77830.83
4491774-49177433.11033.16
5487297-48729732.80832.86
6477296-47729632.13532.19
1440min1786857-78685752.97661.2913.4153.1061.4013.38
21035543-103554369.72069.83
3769949-76994951.83851.94
4849130-84913057.16957.27
51016800-101680068.45868.56
61003858-100385867.58667.69
极限1880141-88014159.25767.8810.0159.4568.089.99
21103641-110364174.30574.52
3895070-89507060.26260.44
4997043-99704367.12867.32
51091217-109121773.46873.67
61082515-108251572.88273.09
氟伐他汀钠缓释片项目信息
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%
110.741414674141548414154591414955141463714150420.03
211.231479915147922314795690.04
单位质量响应值RSD%判断
131754.38131751.470.01数据可信
供试品溶液-X0734批-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%
240min1192534-19253412.95713.7213.1212.9613.7213.12
2243968-24396816.41816.42
3181264-18126412.19812.20
4203294-20329413.68113.68
5226906-22690615.27015.27
6175658-17565811.82111.82
480min1361387-36138724.32024.6713.4924.3424.6913.49
2442257-44225729.76229.79
3319919-31991921.52921.55
4361504-36150424.32824.35
5402567-40256727.09127.11
6312078-31207821.00221.02
720min1518531-51853134.89534.2210.6434.9534.2810.65
2581858-58185839.15739.23
3452463-45246330.44930.50
4518922-51892234.92134.98
5540676-54067636.38536.45
6438740-43874029.52629.57
1440min1841840-84184056.65356.7113.9056.7656.8213.88
2860055-86005557.87858.01
3751570-75157050.57850.67
41059780-105978071.31971.43
5808425-80842554.40454.52
6734710-73471049.44349.54
极限11095811-109581173.74470.636.7173.9470.836.71
2957542-95754264.43964.65
31025863-102586369.03769.21
41121625-112162575.48175.70
51113321-111332174.92275.12
6983427-98342766.18166.35
氟伐他汀钠缓释片项目信息
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%
110.741413303141351114119501412713141273514128420.05
211.231487405148037014838880.34
单位质量响应值RSD%判断
131549.53132136.060.32数据可信
供试品溶液-X0734批-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%
240min1212732-21273214.30614.2012.1614.3114.2012.16
2199231-19923113.39813.40
3242577-24257716.31316.31
4237629-23762915.98115.98
5200056-20005613.45413.45
6174552-17455211.73911.74
480min1386860-38686026.01725.7911.9826.0425.8111.98
2361406-36140624.30524.32
3451110-45111030.33730.36
4420025-42002528.24728.27
5356305-35630523.96223.98
6325185-32518521.86921.89
720min1524783-52478335.29235.936.6235.3535.996.63
2549963-54996336.98537.04
3581405-58140539.10039.17
4554715-55471537.30537.37
5513766-51376634.55134.61
6480927-48092732.34332.39
1440min1852103-85210357.30459.3512.4957.4259.4612.47
21096033-109603373.70973.82
3892352-89235260.01160.14
4850529-85052957.19957.32
5796006-79600653.53253.64
6808085-80808554.34454.44
极限1946035-94603563.62169.2811.2163.8269.4811.20
21169305-116930578.63678.86
31181279-118127979.44279.66
4964678-96467864.87565.08
5920025-92002561.87262.06
6999423-99942367.21267.39
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