厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.598306628279978288658298398307128296150.15
214.608313338321858317590.08
单位质量响应值RSD%判断
56861.8956969.790.14数据可信
供试品溶液-1批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1608542-6085425.1206.4939.945.126.4939.94
2970604-9706048.1678.17
31145172-11451729.6369.64
4318065-3180652.6762.68
5616217-6162175.1855.18
6967282-9672828.1398.14
10min11898304-189830415.97216.697.2416.0316.767.38
22094018-209401817.61917.71
32109889-210988917.75317.86
41768786-176878614.88314.91
51918877-191887716.14616.20
62114666-211466617.79317.88
15min12154838-215483818.13118.973.1918.3719.233.31
22286859-228685919.24219.53
32298286-229828619.33819.64
42175315-217531518.30318.50
52283989-228398919.21819.45
62330069-233006919.60519.89
20min12231692-223169218.77819.201.6719.2119.671.80
22293450-229345019.29719.80
32284465-228446519.22219.74
42241438-224143818.86019.26
52318382-231838219.50719.96
62321393-232139319.53220.04
30min12236315-223631518.81719.231.4519.4619.911.52
22311621-231162119.45020.16
32281211-228121119.19419.93
42265451-226545119.06219.67
52329404-232940419.60020.27
62288188-228818819.25319.98
45min12263071-226307119.04219.081.0919.9019.981.12
22289329-228932919.26320.19
32241656-224165618.86119.81
42240574-224057418.85219.67
52300827-230082719.35920.24
62271865-227186519.11620.05
60min12221654-222165418.69319.031.4019.7620.141.48
22283784-228378419.21620.36
32243534-224353418.87720.03
42238304-223830418.83319.86
52300815-230081519.35920.46
62284309-228430919.22020.37
极限12223182-222318218.70618.830.9719.9820.141.08
22246655-224665518.90420.26
32224171-222417118.71420.08
42209964-220996418.59519.83
52264055-226405519.05020.37
62257113-225711318.99220.35
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.598302358311848313788307338303358307730.07
214.608368348372778370560.04
单位质量响应值RSD%判断
56941.2657332.600.49数据可信
供试品溶液-1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%
5min139691-396910.3330.3115.470.330.3115.06
237343-373430.3130.31
342747-427470.3580.36
428068-280680.2350.24
542712-427120.3580.36
633321-333210.2790.28
10min184135-841350.7050.693.740.710.703.84
281843-818430.6860.69
384151-841510.7050.71
478483-784830.6580.66
586365-863650.7240.73
679179-791790.6640.67
15min1105459-1054590.8840.862.270.900.872.57
2101695-1016950.8520.86
3103297-1032970.8660.88
499262-992620.8320.84
5103814-1038140.8700.88
6100331-1003310.8410.85
20min1115250-1152500.9660.941.820.990.962.09
2112156-1121560.9400.96
3111437-1114370.9340.96
4109219-1092190.9150.93
5113384-1133840.9500.97
6111568-1115680.9350.95
30min1125945-1259451.0561.051.041.091.081.09
2123628-1236281.0361.07
3125630-1256301.0531.08
4123063-1230631.0311.06
5125295-1252951.0501.08
6126029-1260291.0561.09
45min1137589-1375891.1531.141.361.201.181.25
2134194-1341941.1251.17
3135991-1359911.1401.18
4134855-1348551.1301.17
5134193-1341931.1251.17
6138678-1386781.1621.20
60min1145459-1454591.2191.191.441.281.251.58
2141141-1411411.1831.24
3142086-1420861.1911.25
4139212-1392121.1671.22
5141143-1411431.1831.24
6142012-1420121.1901.25
极限1145426-1454261.2191.210.981.291.280.95
2143667-1436671.2041.27
3143302-1433021.2011.27
4142009-1420091.1901.26
5144446-1444461.2111.28
6145723-1457231.2211.29
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.598246928248428255808258428249608251830.07
214.608296918303328300120.06
单位质量响应值RSD%判断
56558.1256850.140.37数据可信
供试品溶液-1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%
5min1140658-1406581.1882.6239.271.192.6239.23
2429729-4297293.6293.63
3362122-3621223.0583.06
4173669-1736691.4671.47
5356852-3568523.0143.01
6397390-3973903.3563.36
10min1952881-9528818.0488.909.118.068.939.19
21136028-11360289.5949.63
31131163-11311639.5539.59
4912934-9129347.7107.73
51093735-10937359.2379.27
61094337-10943379.2429.28
15min11334748-133474811.27311.712.7211.3811.842.85
21423299-142329912.02112.17
31418620-141862011.98112.12
41348752-134875211.39111.49
51410818-141081811.91512.05
61383944-138394411.68811.83
20min11503898-150389812.70113.101.9112.9313.361.97
21568129-156812913.24413.52
31589910-158991013.42813.70
41557278-155727813.15213.38
51554727-155472713.13113.40
61534395-153439512.95913.23
30min11712193-171219314.46014.892.5214.8315.302.45
21768424-176842414.93515.36
31782793-178279315.05715.48
41834535-183453515.49415.87
51758548-175854814.85215.27
61721952-172195214.54314.96
45min11882971-188297115.90316.253.7216.4316.823.57
21909956-190995616.13116.72
31930397-193039716.30316.89
42061496-206149617.41017.96
51905616-190561616.09416.67
61857367-185736715.68616.26
60min11945830-194583016.43417.004.3717.1417.754.21
22009799-200979916.97417.75
32009761-200976116.97417.74
42184223-218422318.44719.19
51962500-196250016.57417.33
61965871-196587116.60317.35
极限11991681-199168116.82117.484.0817.7118.423.93
22061347-206134717.40918.37
32053077-205307717.33918.30
42228501-222850118.82119.77
52008143-200814316.96017.90
62078455-207845517.55418.49
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