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%
115.328296998296488274408287458286948288450.12
215.228330798334288332540.03
单位质量响应值RSD%判断
54102.1554747.310.84数据可信
供试品溶液-25101001批-厄贝沙坦-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%
5min1475284-4752844.1828.2128.714.188.2128.71
2738686-7386866.5006.50
31119935-11199359.8559.85
41108097-11080979.7519.75
51119596-11195969.8529.85
61038900-10389009.1429.14
10min11826653-182665316.07417.484.1016.1217.574.22
21976844-197684417.39517.47
32016928-201692817.74817.86
42041207-204120717.96218.07
52016393-201639317.74317.85
62038344-203834417.93618.04
15min12133427-213342718.77319.141.8919.0019.431.89
22230183-223018319.62519.89
32137054-213705418.80519.11
42194234-219423419.30819.62
52148556-214855618.90619.21
62207791-220779119.42719.73
20min12138831-213883118.82119.371.9019.2519.871.96
22252598-225259819.82220.31
32199419-219941919.35419.87
42209844-220984419.44619.97
52172005-217200519.11319.63
62236364-223636419.67920.20
30min12162630-216263019.03019.281.6019.6719.991.60
22239059-223905919.70320.41
32157956-215795618.98919.72
42216941-221694119.50820.25
52159892-215989219.00619.74
62207684-220768419.42720.16
45min12172740-217274019.11919.391.3719.9720.311.42
22224676-222467619.57620.50
32187028-218702819.24520.19
42182928-218292819.20920.16
52198071-219807119.34220.28
62252871-225287119.82420.78
60min12124020-212402018.69019.121.6019.7620.261.64
22209861-220986119.44620.59
32138911-213891118.82119.98
42181557-218155719.19720.37
52176790-217679019.15520.31
62203956-220395619.39420.57
极限12121396-212139618.66719.051.3919.9420.401.42
22213325-221332519.47620.83
32157808-215780818.98820.35
42156812-215681218.97920.36
52176492-217649219.15220.52
62161977-216197719.02420.41
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20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%
110.241273581271101267961268611271521270550.18
210.281276971276211276590.05
单位质量响应值RSD%判断
12407.7112418.190.06数据可信
供试品溶液-25101001批-非奈利酮-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%
5min123833-2383334.60970.6731.4934.6170.6731.48
238784-3878456.31956.32
354544-5454479.20579.20
448442-4844270.34470.34
564246-6424693.29393.29
662157-6215790.26090.26
10min1129161-129161187.558259.4116.60187.94260.2016.62
2162267-162267235.632236.26
3181758-181758263.936264.82
4209490-209490304.206304.99
5204726-204726297.288298.32
6184463-184463267.864268.87
15min1218842-218842317.786372.379.34320.25376.039.41
2253614-253614368.280371.52
3247100-247100358.821362.63
4290565-290565421.937426.10
5270210-270210392.379396.72
6258244-258244375.003378.98
20min1277261-277261402.618436.655.48408.62444.465.60
2294102-294102427.073434.41
3298251-298251433.098440.90
4326422-326422474.006482.86
5310043-310043450.222458.92
6298103-298103432.883441.03
30min1336734-336734488.980488.852.54499.45501.502.60
2333046-333046483.625495.71
3330158-330158479.431492.04
4352335-352335511.635525.75
5338561-338561491.634505.34
6329012-329012477.767490.72
45min1361653-361653525.166513.731.31541.07531.821.20
2348435-348435505.972523.43
3351466-351466510.373528.31
4354561-354561514.868534.67
5355486-355486516.211535.38
6351061-351061509.785528.05
60min1359693-359693522.320511.921.33544.06535.721.26
2349323-349323507.261530.34
3348634-348634506.261529.87
4355443-355443516.148541.67
5354203-354203514.348539.25
6347883-347883505.170529.10
极限1360007-360007522.776510.511.65550.32540.001.47
2350674-350674509.223537.94
3352693-352693512.155541.39
4351175-351175509.951541.21
5352801-352801512.312542.93
6342007-342007496.638526.18
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%
115.328422768423698424038419878414228420910.05
215.228415828414218415020.02
单位质量响应值RSD%判断
54966.7855289.220.42数据可信
供试品溶液-25101001批-厄贝沙坦-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%
5min139719-397190.3450.2733.880.350.2733.46
222628-226280.1970.20
337623-376230.3270.33
433591-335910.2920.29
513373-133730.1160.12
636469-364690.3170.32
10min179393-793930.6900.5917.320.690.6017.43
261926-619260.5380.54
378523-785230.6820.69
452750-527500.4580.46
558863-588630.5110.51
678194-781940.6790.68
15min196770-967700.8410.797.190.850.807.31
289050-890500.7740.78
395773-957730.8320.84
479819-798190.6930.70
587969-879690.7640.77
695180-951800.8270.84
20min1105035-1050350.9120.893.810.930.913.94
299682-996820.8660.88
3106579-1065790.9260.95
497011-970110.8430.86
5101566-1015660.8820.90
6106415-1064150.9240.94
30min1116945-1169451.0161.011.131.051.041.17
2114212-1142120.9921.02
3117648-1176481.0221.05
4117390-1173901.0201.05
5116889-1168891.0151.04
6117629-1176291.0221.05
45min1127668-1276681.1091.110.771.151.150.66
2126890-1268901.1021.14
3127400-1274001.1071.15
4127826-1278261.1101.15
5129431-1294311.1241.16
6128991-1289911.1211.16
60min1133620-1336201.1611.161.271.221.211.43
2131532-1315321.1431.19
3131267-1312671.1401.19
4134444-1344441.1681.22
5135531-1355311.1771.23
6134279-1342791.1661.22
极限1134318-1343181.1671.194.641.231.264.58
2132995-1329951.1551.22
3149883-1498831.3021.37
4137376-1373761.1931.26
5133712-1337121.1621.22
6135337-1353371.1761.24
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20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%
110.241294781297031295241295171295221295490.07
210.281294111293761293940.02
单位质量响应值RSD%判断
12651.2712586.960.37数据可信
供试品溶液-25101001批-非奈利酮-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%
5min164500-6450092.13364.7041.6792.1364.7041.66
234058-3405848.64948.65
365369-6536993.37493.37
435254-3525450.35750.36
518694-1869426.70326.70
653879-5387976.96176.96
10min1160048-160048228.614180.1128.95229.64180.8428.98
298164-98164140.219140.76
3151949-151949217.046218.08
4142267-142267203.216203.78
565725-6572593.88294.18
6138414-138414197.712198.57
15min1222390-222390317.664268.1821.63321.23270.9021.72
2166774-166774238.222240.32
3213043-213043304.313307.76
4208062-208062297.198300.02
5114567-114567163.649164.99
6201644-201644288.031291.08
20min1245240-245240350.304314.4516.88357.40320.1517.02
2205367-205367293.349298.09
3239676-239676342.356349.19
4245690-245690350.946357.07
5150726-150726215.299218.46
6234148-234148334.460340.71
30min1269773-269773385.347361.5010.70396.33370.7010.96
2245932-245932351.292359.30
3261677-261677373.783384.42
4280103-280103400.102410.12
5203003-203003289.972295.52
6257985-257985368.509378.48
45min1289361-289361413.327396.475.60428.59409.685.98
2276128-276128394.424406.33
3278962-278962398.473413.26
4292590-292590417.939432.40
5248677-248677355.213363.99
6279662-279662399.472413.54
60min1299703-299703428.099411.254.09447.96428.874.43
2286801-286801409.670425.96
3283043-283043404.302423.52
4302645-302645432.302451.41
5270637-270637386.581399.30
6284625-284625406.562425.06
极限1300749-300749429.593419.443.29454.21441.633.67
2295548-295548422.164443.01
3292981-292981418.498442.20
4305363-305363436.184460.10
5277652-277652396.601413.62
6289560-289560413.611436.63
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%
115.328289608294208293198291278293618292370.03
215.228338148332818335480.05
单位质量响应值RSD%判断
54127.7454766.620.83数据可信
供试品溶液-25101001批-厄贝沙坦-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%
5min1444800-4448003.9122.7334.703.912.7334.70
2346601-3466013.0493.05
3217215-2172151.9111.91
4420500-4205003.6993.70
5201190-2011901.7701.77
6233057-2330572.0502.05
10min11092944-10929449.6138.927.909.668.967.98
21049566-10495669.2329.27
31011500-10115008.8978.92
41084461-10844619.5399.58
5967274-9672748.5088.53
6881915-8819157.7577.78
15min11374934-137493412.09411.835.4912.2411.965.54
21391011-139101112.23512.37
31369435-136943512.04512.17
41397590-139759012.29312.44
51336337-133633711.75411.87
61201036-120103610.56410.67
20min11538633-153863313.53413.384.0213.8213.644.04
21555252-155525213.68013.95
31554189-155418913.67013.92
41520067-152006713.37013.65
51558402-155840213.70813.95
61399894-139989412.31312.54
30min11738019-173801915.28715.113.8315.7215.523.84
21731963-173196315.23415.66
31784424-178442415.69616.10
41712204-171220415.06015.49
51750160-175016015.39415.79
61593404-159340414.01514.38
45min11868727-186872716.43716.473.1817.0417.043.18
21899903-189990316.71117.30
31929830-192983016.97517.55
41847341-184734116.24916.85
51918163-191816316.87217.44
61768024-176802415.55116.07
60min11948401-194840117.13817.133.1817.9317.903.17
21971725-197172517.34318.12
32006571-200657117.65018.42
41904647-190464716.75317.53
52007074-200707417.65418.41
61849248-184924816.26616.96
极限12000821-200082117.59917.682.6318.5818.632.62
22047512-204751218.01018.98
32045328-204532817.99018.96
41957592-195759217.21918.19
52068868-206886818.19819.15
61939499-193949917.06017.93
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20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%
110.241279401279881280481280311279991280010.04
210.281287161286121286640.06
单位质量响应值RSD%判断
12500.1012515.950.09数据可信
供试品溶液-25101001批-非奈利酮-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%
5min165557-6555794.47449.7446.9094.4749.7446.90
226378-2637838.01338.01
329039-2903941.84841.85
430131-3013143.42143.42
536563-3656352.69152.69
619442-1944228.01828.02
10min1132126-132126190.405141.7520.71191.46142.3020.80
291855-91855132.371132.79
397483-97483140.482140.95
4102552-102552147.787148.27
597343-97343140.280140.87
668818-6881899.17399.48
15min1160871-160871231.830201.3512.05234.99203.4812.17
2142414-142414205.231207.12
3136292-136292196.409198.43
4151937-151937218.955221.08
5135021-135021194.577196.72
6111801-111801161.115162.53
20min1176737-176737254.694232.377.56260.44236.747.75
2163133-163133235.089239.26
3157001-157001226.253230.46
4170686-170686245.974250.53
5158247-158247228.048232.35
6141677-141677204.169207.37
30min1196645-196645283.383267.005.00291.95273.955.21
2184612-184612266.042272.83
3183298-183298264.149270.87
4195028-195028281.053288.34
5179856-179856259.189266.03
6172236-172236248.208253.68
45min1211700-211700305.079296.862.68316.80306.772.90
2206003-206003296.869306.61
3203313-203313292.992302.65
4213472-213472307.632318.05
5201359-201359290.176299.90
6200117-200117288.387296.62
60min1222328-222328320.395314.351.79335.50327.562.02
2217224-217224313.039326.08
3215956-215956311.212324.12
4223642-223642322.288336.12
5214593-214593309.248322.19
6215038-215038309.889321.32
极限1226968-226968327.081325.971.01345.75342.681.22
2227526-227526327.885344.40
3223867-223867322.612338.98
4229758-229758331.102348.51
5224807-224807323.967340.35
6224276-224276323.202338.08
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