氟伐他汀钠片项目信息
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%
110.741393884139321513917961392833139137413926200.08
211.231468801146823614685180.03
单位质量响应值RSD%判断
129666.67130767.410.60数据可信
供试品溶液-X0375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%
240min1394152-39415226.83827.3218.8026.8427.3218.81
2456534-45653431.08631.09
3464675-46467531.64031.64
4353593-35359324.07724.08
5461402-46140231.41731.42
6277047-27704718.86418.86
480min1805637-80563754.85755.0416.7254.9055.0816.72
2908519-90851961.86261.91
3906077-90607761.69661.74
4708037-70803748.21148.25
5930020-93002063.32663.37
6592058-59205840.31440.34
720min11166004-116600479.39475.2511.4279.5275.3711.42
21119543-111954376.23176.37
31112063-111206375.72275.86
41076904-107690473.32873.44
51269620-126962086.45086.59
6886688-88668860.37660.46
960min11403528-140352895.56892.168.8395.8192.408.84
21378576-137857693.86994.12
31351620-135162092.03392.29
41368572-136857293.18893.41
51488388-1488388101.346101.62
61130507-113050776.97777.16
1200min11476937-1476937100.56699.183.06100.9599.563.09
21459648-145964899.38999.78
31431104-143110497.44597.84
41469232-1469232100.042100.40
51517073-1517073103.299103.72
61385643-138564394.35094.64
1440min11469672-1469672100.072100.551.35100.61101.081.36
21479158-1479158100.717101.26
31452090-145209098.87499.41
41466813-146681399.877100.39
51511338-1511338102.909103.49
61481260-1481260100.861101.30
极限11469664-1469664100.071100.601.50100.76101.281.49
21475217-1475217100.449101.14
31448803-144880398.65199.34
41464337-146433799.708100.37
51508528-1508528102.717103.45
61497999-1497999102.000102.59
氟伐他汀钠片项目信息
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%
110.741389698139252213938831390451139832213929750.25
211.231449991145868514543380.43
单位质量响应值RSD%判断
129699.72129504.720.11数据可信
供试品溶液-X0375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%
240min1300053-30005320.52824.9817.1420.5324.9817.14
2474348-47434832.45232.45
3399647-39964727.34127.34
4329825-32982522.56422.56
5339709-33970923.24023.24
6346971-34697123.73723.74
480min1581351-58135139.77251.3914.7639.8051.4214.76
2901720-90172061.68961.74
3836856-83685657.25257.29
4712869-71286948.76948.80
5718619-71861949.16349.20
6755321-75532151.67451.71
720min1865759-86575959.22971.9511.2559.3272.0611.25
21109914-110991475.93276.07
31189359-118935981.36881.49
4981967-98196767.17967.29
51024823-102482370.11170.22
61138038-113803877.85777.97
960min11079671-107967173.86388.8310.5374.0489.0510.53
21366522-136652293.48893.74
31433115-143311598.04498.29
41201032-120103282.16682.37
51296334-129633488.68688.90
61413675-141367596.71496.94
1200min11352199-135219992.50897.573.1892.8097.933.21
21444888-144488898.84999.24
31463786-1463786100.142100.54
41402394-140239495.94296.27
51418945-141894597.07497.42
61475132-1475132100.918101.29
1440min11467537-1467537100.39899.920.65100.83100.420.64
21451539-145153999.30499.85
31459822-145982299.871100.42
41460585-146058599.923100.40
51449406-144940699.15899.65
61474423-1474423100.870101.40
极限11482146-1482146101.398100.020.88101.98100.680.85
21449740-144974099.18199.87
31455974-145597499.607100.30
41458948-145894899.811100.44
51452418-145241899.364100.01
61473053-1473053100.776101.45
氟伐他汀钠片项目信息
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%
110.741393315139249713929751392586139156313925870.05
211.231475022147419114746060.04
单位质量响应值RSD%判断
129663.59131309.530.90数据可信
供试品溶液-2024022621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%
240min1303248-30324820.60627.6613.9620.6127.6613.95
2449642-44964230.55430.55
3452807-45280730.76930.77
4411709-41170927.97627.98
5438679-43867929.80929.81
6386296-38629626.25026.25
480min1597071-59707140.57254.1814.4440.6054.2214.44
2884798-88479860.12460.17
3896936-89693660.94960.99
4795274-79527454.04054.08
5869608-86960859.09259.14
6740014-74001450.28550.32
720min1879175-87917559.74279.4514.2959.8379.5714.29
21293639-129363987.90588.04
31319433-131943389.65889.80
41165660-116566079.20979.33
51270889-127088986.35986.49
61086114-108611473.80473.92
960min11126995-112699576.58196.1410.8276.7696.3810.83
21522944-1522944103.487103.75
31516554-1516554103.053103.32
41443448-144344898.08598.33
51510592-1510592102.648102.91
61368603-136860392.99993.22
1200min11356295-135629592.163100.594.2992.46100.984.32
21519304-1519304103.240103.66
31520681-1520681103.333103.76
41472638-1472638100.069100.46
51516449-1516449103.046103.46
61496722-1496722101.705102.07
1440min11461630-146163099.321101.741.7199.76102.281.74
21516001-1516001103.015103.59
31513041-1513041102.814103.40
41467175-146717599.697100.24
51513481-1513481102.844103.42
61512022-1512022102.745103.26
极限11489522-1489522101.216101.921.36101.80102.621.37
21509640-1509640102.583103.32
31508499-1508499102.505103.24
41463399-146339999.441100.13
51509719-1509719102.588103.31
61518946-1518946103.215103.89
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