非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.903541835327353163526635181353020.25
210.993599036003359960.03
单位质量响应值RSD%判断
3238.723275.340.80数据可信
供试品溶液-6042701批-多替诺雷-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%
5min13654-365410.06610.628.9110.0710.628.88
24201-420111.57311.57
34116-411611.33911.34
44078-407811.23411.23
53302-33029.0969.10
63784-378410.42410.42
10min18395-839523.12623.375.1223.1423.385.13
28886-888624.47924.50
38816-881624.28624.31
48351-835123.00523.02
57720-772021.26721.28
68726-872624.03824.06
15min111142-1114230.69430.873.5530.7530.933.56
211601-1160131.95832.02
311443-1144331.52331.58
410912-1091230.06030.12
510596-1059629.19029.24
611547-1154731.80931.87
20min113031-1303135.89736.022.8536.0036.122.86
213510-1351037.21737.33
313302-1330236.64436.76
412644-1264434.83134.94
512627-1262734.78534.88
613330-1333036.72136.83
30min115567-1556742.88443.052.6043.0543.222.60
216057-1605744.23344.41
315823-1582343.58943.76
415038-1503841.42641.59
515290-1529042.12142.28
615994-1599444.06044.23
45min118017-1801749.63349.852.1549.8750.092.15
218487-1848750.92851.18
318295-1829550.39950.64
417525-1752548.27748.51
517791-1779149.01049.24
618466-1846650.87051.11
60min119711-1971154.29954.512.0154.6254.832.01
220084-2008455.32755.66
319913-1991354.85655.19
419129-1912952.69653.01
519630-1963054.07654.39
620256-2025655.80156.13
90min121929-2192960.40960.572.0360.8260.992.03
222418-2241861.75762.18
322081-2208160.82861.25
421279-2127958.61959.02
521754-2175459.92760.33
622470-2247061.90062.32
120min123613-2361365.04965.111.9765.5665.631.97
224002-2400266.12066.65
323723-2372365.35265.87
422793-2279362.79063.29
523575-2357564.94465.44
624111-2411166.42066.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限124046-2404666.24166.251.9766.8666.871.97
224426-2442667.28867.93
324204-2420466.67767.31
423220-2322063.96664.57
523870-2387065.75766.36
624527-2452767.56668.20
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.862660472654832652112648622648712652950.19
211.102708462704352706400.11
单位质量响应值RSD%判断
24428.6424381.980.14数据可信
供试品溶液-6042701批-非布司他-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%
5min12786-27861.0260.997.661.030.997.77
22934-29341.0811.08
32753-27531.0141.01
42760-27601.0171.02
52466-24660.9080.91
62401-24010.8850.88
10min14338-43381.5981.553.071.601.563.15
24359-43591.6061.61
34234-42341.5601.56
44218-42181.5541.56
54018-40181.4801.48
64127-41271.5201.52
15min14969-49691.8311.773.831.831.773.86
24829-48291.7791.78
34916-49161.8111.82
44922-49221.8131.82
54662-46621.7171.72
64498-44981.6571.66
20min15091-50911.8761.855.281.881.855.13
25280-52801.9451.95
35088-50881.8741.88
45092-50921.8761.88
55020-50201.8491.86
64503-45031.6591.67
30min15204-52041.9171.873.041.931.883.06
25035-50351.8551.87
35004-50041.8431.85
45270-52701.9411.95
55082-50821.8721.88
64834-48341.7811.79
45min15147-51471.8961.883.341.911.893.26
25103-51031.8801.89
35258-52581.9371.95
45159-51591.9011.91
55131-51311.8901.90
64765-47651.7551.77
60min15274-52741.9431.913.471.961.923.54
25360-53601.9751.99
35214-52141.9211.94
45104-51041.8801.90
55263-52631.9391.96
64856-48561.7891.80
90min15194-51941.9131.862.941.931.883.01
25136-51361.8921.91
35172-51721.9051.93
45071-50711.8681.89
54890-48901.8011.82
64848-48481.7861.80
120min15281-52811.9461.903.351.971.923.30
25154-51541.8991.92
35237-52371.9291.95
45223-52231.9241.95
55254-52541.9361.96
64821-48211.7761.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15307-53071.9551.902.761.981.932.71
25311-53111.9571.98
35127-51271.8891.92
45171-51711.9051.93
55111-51111.8831.91
64929-49291.8161.84
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.903517635241351653513335198351830.12
210.993623436172362030.13
单位质量响应值RSD%判断
3227.803294.181.44数据可信
供试品溶液-6042702批-多替诺雷-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%
5min14022-402211.06710.0310.2711.0710.0310.28
23294-32949.0649.06
33438-34389.4609.46
43662-366210.07610.08
53296-32969.0699.07
64165-416511.46111.46
10min18471-847123.30921.964.4523.3321.984.46
27686-768621.14921.16
37979-797921.95521.97
48018-801822.06322.08
57496-749620.62620.64
68237-823722.66522.68
15min111231-1123130.90429.522.7430.9629.572.74
210505-1050528.90628.96
310820-1082029.77329.82
410599-1059929.16529.22
510417-1041728.66428.71
610800-1080029.71829.77
20min113110-1311036.07434.682.4136.1834.782.42
212412-1241234.15334.25
312742-1274235.06135.16
412444-1244434.24134.34
512256-1225633.72433.82
612648-1264834.80334.91
30min115492-1549242.62841.441.6842.8041.601.69
215081-1508141.49741.65
315190-1519041.79741.96
414829-1482940.80440.96
514853-1485340.87041.02
614923-1492341.06341.23
45min117878-1787849.19448.171.4449.4348.401.44
217659-1765948.59148.82
317594-1759448.41248.64
417212-1721247.36147.59
517280-1728047.54847.77
617419-1741947.93148.16
60min119736-1973654.30652.921.6754.6353.231.67
219408-1940853.40453.71
319332-1933253.19553.51
418892-1889251.98452.29
518969-1896952.19652.50
619055-1905552.43252.75
90min121950-2195060.39859.061.5460.8159.461.54
221681-2168159.65860.05
321608-2160859.45759.86
421123-2112358.12358.52
521213-2121358.37058.76
621216-2121658.37958.78
120min123503-2350364.67263.321.6465.1863.811.63
223283-2328364.06664.56
323223-2322363.90164.40
422554-2255462.06062.55
522770-2277062.65563.14
622734-2273462.55663.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限123955-2395565.91564.491.6466.5465.101.65
223702-2370265.21965.82
323625-2362565.00765.61
422931-2293163.09863.69
523161-2316163.73064.32
623256-2325663.99264.59
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.862644952651592645122644722650962647470.14
211.102761552762152761850.02
单位质量响应值RSD%判断
24378.1824881.531.45数据可信
供试品溶液-6042702批-非布司他-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%
5min13208-32081.1711.3628.661.171.3628.65
23229-32291.1791.18
33072-30721.1221.12
42733-27330.9981.00
54609-46091.6831.68
65447-54471.9891.99
10min14454-44541.6261.646.671.631.646.77
24342-43421.5851.59
34273-42731.5601.56
44190-41901.5301.53
54782-47821.7461.75
64942-49421.8041.81
15min14949-49491.8071.793.631.811.793.76
25076-50761.8531.86
34828-48281.7631.77
44576-45761.6711.67
54906-49061.7911.80
65021-50211.8331.84
20min14980-49801.8181.842.451.831.842.35
25163-51631.8851.89
35108-51081.8651.87
44827-48271.7621.77
54985-49851.8201.83
65107-51071.8641.87
30min15128-51281.8721.871.041.881.881.07
25114-51141.8671.88
35202-52021.8991.91
45086-50861.8571.87
55136-51361.8751.89
65044-50441.8411.85
45min14895-48951.7871.883.891.801.903.94
25489-54892.0042.02
35098-50981.8611.87
45145-51451.8781.89
55077-50771.8541.87
65269-52691.9241.94
60min15001-50011.8261.883.421.841.903.48
25312-53121.9391.96
34989-49891.8211.84
45322-53221.9431.96
55289-52891.9311.95
64973-49731.8161.83
90min15287-52871.9301.882.611.951.902.59
25246-52461.9151.94
35179-51791.8911.91
45253-52531.9181.94
54949-49491.8071.83
65043-50431.8411.86
120min14988-49881.8211.842.381.841.862.27
25258-52581.9201.94
35065-50651.8491.87
45046-50461.8421.86
54918-49181.7951.82
64968-49681.8141.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15072-50721.8521.842.801.881.872.76
25236-52361.9121.94
35120-51201.8691.90
44971-49711.8151.84
55031-50311.8371.86
64821-48211.7601.79
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.903627336204362323622736135362140.15
210.993535935270353140.18
单位质量响应值RSD%判断
3322.393213.282.37数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-6042703批-多替诺雷-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%
5min14034-403411.07910.345.5811.0810.345.59
23690-369010.13410.13
33888-388810.67810.68
43853-385310.58210.58
53697-369710.15310.15
63426-34269.4099.41
10min18623-862323.68222.694.0523.7022.714.04
28058-805822.13022.15
38244-824422.64122.66
48563-856323.51723.53
58358-835822.95422.97
67728-772821.22421.24
15min111205-1120530.77330.012.9330.8330.062.93
210765-1076529.56429.62
310925-1092530.00430.06
411186-1118630.72130.78
511108-1110830.50630.56
610374-1037428.49128.54
20min112948-1294835.56035.071.7435.6735.181.75
212718-1271834.92835.03
312795-1279535.13935.25
412933-1293335.51835.63
512875-1287535.35935.47
612354-1235433.92834.03
30min115451-1545142.43442.031.6642.6042.201.67
215326-1532642.09042.25
315244-1524441.86542.03
415478-1547842.50842.68
515502-1550242.57442.74
614828-1482840.72340.88
45min117878-1787849.09948.850.9049.3449.080.91
217809-1780948.91049.14
317751-1775148.75048.98
417878-1787849.09949.34
517916-1791649.20449.44
617484-1748448.01748.24
60min119535-1953553.65053.471.0153.9753.781.01
219496-1949653.54353.86
319457-1945753.43653.75
419534-1953453.64753.97
519686-1968654.06554.38
619104-1910452.46652.77
90min121683-2168359.54959.730.8759.9660.140.88
221791-2179159.84660.25
321686-2168659.55759.96
421858-2185860.03060.44
522019-2201960.47260.88
621460-2146058.93759.33
120min123288-2328863.95763.910.9264.4764.410.93
223395-2339564.25164.75
323166-2316663.62264.13
423379-2337964.20764.72
523492-2349264.51765.03
622896-2289662.88063.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限123817-2381765.41065.210.9666.0365.820.96
223764-2376465.26465.87
323694-2369465.07265.68
423867-2386765.54766.16
523997-2399765.90466.52
623334-2333464.08364.68
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.862761362755292756852754422747902755160.18
211.102654982653692654340.04
单位质量响应值RSD%判断
25369.8023912.974.19数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-6042703批-非布司他-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%
5min12435-24350.8890.808.980.890.808.95
22094-20940.7650.76
32218-22180.8100.81
42367-23670.8640.86
52175-21750.7940.79
61883-18830.6880.69
10min14129-41291.5081.482.951.511.482.98
24138-41381.5111.51
34031-40311.4721.47
44188-41881.5291.53
53990-39901.4571.46
63863-38631.4111.41
15min14831-48311.7641.723.021.771.723.13
24734-47341.7291.73
34794-47941.7511.75
44776-47761.7441.75
54684-46841.7111.71
64438-44381.6211.62
20min14964-49641.8131.812.131.821.812.17
24961-49611.8121.82
35124-51241.8711.88
44898-48981.7891.80
54912-49121.7941.80
64807-48071.7551.76
30min15135-51351.8751.842.741.891.852.75
25104-51041.8641.87
34808-48081.7561.77
45067-50671.8501.86
55191-51911.8961.91
64966-49661.8141.82
45min15076-50761.8541.872.211.871.882.35
25210-52101.9031.92
35269-52691.9241.94
44957-49571.8101.82
55062-50621.8491.86
65072-50721.8521.86
60min15186-51861.8941.851.431.911.871.42
25044-50441.8421.86
35050-50501.8441.86
45027-50271.8361.85
55010-50101.8301.85
65150-51501.8811.90
90min14966-49661.8141.831.351.831.851.32
25106-51061.8651.88
34937-49371.8031.82
45080-50801.8551.87
55025-50251.8351.85
64974-49741.8161.83
120min15001-50011.8261.842.221.851.872.22
25114-51141.8681.89
35149-51491.8801.90
45078-50781.8541.88
55107-51071.8651.89
64845-48451.7691.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15261-52611.9211.833.261.951.853.25
25060-50601.8481.87
35058-50581.8471.87
44819-48191.7601.79
54968-49681.8141.84
64843-48431.7691.79
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