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%
111.01 1426489142921614304621430445143130114295830.14
210.72 1421973142045814212160.08
单位质量响应值RSD%判断
129844.05132576.121.48数据可信
供试品溶液-2024041521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%
240min1170782-17078211.54212.162.9311.5412.162.93
2182976-18297612.36612.37
3185168-18516812.51412.51
4183373-18337312.39312.39
5180110-18011012.17212.17
6177436-17743611.99111.99
480min1293156-29315619.81219.679.4719.8319.689.45
2239701-23970116.19916.22
3306226-30622620.69520.71
4296712-29671220.05220.07
5320841-32084121.68321.70
6289440-28944019.56119.58
720min1393005-39300526.56026.901.3726.6126.951.36
2392160-39216026.50326.55
3405880-40588027.43027.48
4402541-40254127.20427.25
5398788-39878826.95127.00
6395899-39589926.75626.80
1440min1572847-57284738.71439.391.7538.8039.471.75
2578045-57804539.06539.15
3594394-59439440.17040.26
4574278-57427838.81138.90
5596287-59628740.29840.39
6580846-58084639.25539.34
极限1629311-62931142.53042.891.3142.6743.041.31
2639960-63996043.25043.39
3641711-64171143.36843.52
4620686-62068641.94742.09
5640849-64084943.31043.46
6635711-63571142.96343.11
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%
111.01 1442604144648714443151446290144442414448240.12
210.72 1406533140449014055120.11
单位质量响应值RSD%判断
131228.34131111.190.07数据可信
供试品溶液-2024041521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%
240min1163587-16358711.05811.4211.1611.0611.4211.15
2190621-19062112.88512.89
3164623-16462311.12811.13
4184638-18463812.48112.48
5137388-1373889.2879.29
6173039-17303911.69711.70
480min1300578-30057820.31820.391.9820.3320.401.98
2297520-29752020.11120.13
3306822-30682220.74020.76
4310703-31070321.00221.02
5299078-29907820.21620.23
6295084-29508419.94619.96
720min1390749-39074926.41326.278.0226.4626.328.01
2421178-42117828.47028.52
3396920-39692026.83026.88
4396780-39678026.82026.87
5328806-32880622.22622.27
6397116-39711626.84326.89
1440min1584709-58470939.52439.664.0439.6139.754.03
2621517-62151742.01242.10
3589731-58973139.86339.95
4561150-56115037.93138.02
5560819-56081937.90937.99
6602550-60255040.73040.82
极限1634405-63440542.88343.283.9443.0343.423.93
2666624-66662445.06145.22
3659299-65929944.56644.71
4603330-60333040.78240.93
5620102-62010241.91642.05
6657784-65778444.46344.61
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%
111.01 1439380144292914425491445917144369514428940.17
210.72 1422717142493714238270.12
单位质量响应值RSD%判断
131053.04132819.680.95数据可信
供试品溶液-2024041721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%
240min1170947-17094711.48911.0511.2411.4911.0511.22
2169322-16932211.37911.38
3171111-17111111.50011.50
4183635-18363512.34112.34
5161541-16154110.85610.86
6129538-1295388.7068.71
480min1269833-26983318.13417.9817.8218.1517.9917.81
2296179-29617919.90519.92
3286967-28696719.28619.30
4299802-29980220.14820.17
5279224-27922418.76518.78
6172818-17281811.61411.63
720min1381990-38199025.67224.718.7425.7224.758.76
2375178-37517825.21425.26
3364605-36460524.50324.55
4397410-39741026.70826.76
5380824-38082425.59325.64
6305801-30580120.55220.58
1440min1573533-57353338.54538.263.6438.6338.343.66
2595088-59508839.99340.08
3556885-55688537.42637.51
4580220-58022038.99439.08
5574427-57442738.60538.69
6535222-53522235.97036.03
极限1618143-61814341.54339.996.0941.6840.136.09
2645864-64586443.40643.55
3567745-56774538.15638.29
4614551-61455141.30141.45
5553429-55342937.19437.33
6570758-57075838.35838.47
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%
111.01 1440198144135614367641438826143922314392730.12
210.72 1424868142279214238300.11
单位质量响应值RSD%判断
130724.16132819.961.13数据可信
供试品溶液-2024041721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%
240min1153143-15314310.30510.7810.7710.3110.7810.77
2168802-16880211.35911.36
3163770-16377011.02011.02
4172436-17243611.60311.60
5174378-17437811.73411.73
6128578-1285788.6528.65
480min1218726-21872614.71817.6912.3014.7317.7112.30
2283218-28321819.05819.07
3287559-28755919.35019.37
4288437-28843719.40919.43
5275043-27504318.50818.53
6224770-22477015.12515.14
720min1361408-36140824.31923.4912.5724.3623.5412.57
2375968-37596825.29925.34
3375432-37543225.26325.31
4326201-32620121.95022.00
5385543-38554325.94325.99
6270304-27030418.18918.22
1440min1565516-56551638.05436.943.3338.1337.023.33
2570915-57091538.41738.50
3524784-52478435.31335.40
4550485-55048537.04237.12
5550928-55092837.07237.16
6531074-53107435.73635.80
极限1596413-59641340.13338.964.9640.2639.094.95
2609556-60955641.01741.16
3538693-53869336.24936.39
4588064-58806439.57139.71
5593164-59316439.91440.05
6547781-54778136.86136.98
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%
111.01 1441581144207614454881442470144191714427060.12
210.72 1414215141357214138940.04
单位质量响应值RSD%判断
131035.97131893.100.47数据可信
供试品溶液-2024041821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%
240min1185265-18526512.49511.7511.1212.5011.7511.13
2134949-1349499.1029.10
3178790-17879012.05812.06
4183050-18305012.34612.35
5180956-18095612.20412.20
6182369-18236912.30012.30
480min1331769-33176922.37620.508.8222.3920.528.81
2252853-25285317.05417.07
3308019-30801920.77420.79
4316483-31648321.34521.36
5305059-30505920.57520.59
6309504-30950420.87420.89
720min1418579-41857928.23126.876.5728.2826.926.58
2346741-34674123.38623.42
3407902-40790227.51127.56
4413708-41370827.90227.95
5401415-40141527.07327.12
6402454-40245427.14327.19
1440min1562142-56214237.91338.821.2338.0138.911.23
2575101-57510138.78738.86
3578323-57832339.00539.10
4580923-58092339.18039.27
5575731-57573138.83038.92
6581373-58137339.21039.30
极限1646646-64664643.61342.313.6443.7642.463.64
2587239-58723939.60639.74
3650384-65038443.86544.01
4625802-62580242.20742.36
5620207-62020741.83041.98
6633569-63356942.73142.88
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%
111.01 1448020144894614482441449565144785914485270.05
210.72 1434659143734614360020.14
单位质量响应值RSD%判断
131564.67133955.411.28数据可信
供试品溶液-2024041821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%
240min1190395-19039512.71711.8912.4912.7211.8912.49
2206369-20636913.78413.78
3154118-15411810.29410.29
4181258-18125812.10612.11
5148785-1487859.9389.94
6186782-18678212.47512.48
480min1315072-31507221.04420.207.3221.0620.227.33
2335593-33559322.41522.44
3283239-28323918.91818.93
4295327-29532719.72519.74
5275765-27576518.41918.43
6310004-31000420.70520.72
720min1405722-40572227.09926.514.1327.1526.564.14
2422428-42242828.21428.27
3386725-38672525.83025.87
4389866-38986626.04026.09
5375900-37590025.10725.15
6401181-40118126.79526.85
1440min1548967-54896736.66637.452.7536.7637.542.76
2582566-58256638.91039.01
3576809-57680938.52638.61
4558690-55869037.31537.40
5546231-54623136.48336.56
6550792-55079236.78836.88
极限1613109-61310940.95040.783.8741.1040.933.85
2617870-61787041.26841.42
3627835-62783541.93442.07
4573404-57340438.29838.44
5593507-59350739.64139.78
6637917-63791742.60742.75
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