非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
19.893765901380020138007393794653379724837917480.39
29.973801134383179138164620.57
单位质量响应值RSD%判断
383392.11382794.580.12数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1546947-54694712.84913.9214.2912.8513.9214.27
2730636-73063617.16517.16
3627727-62772714.74714.75
4614507-61450714.43714.44
5545680-54568012.82012.82
6488969-48896911.48711.49
10min11831663-183166343.03142.415.5243.0542.435.52
21892001-189200144.44944.48
31827296-182729642.92942.95
41901286-190128644.66744.69
51737580-173758040.82140.84
61641000-164100038.55238.57
15min12536566-253656659.59258.582.7559.6858.672.75
22534667-253466759.54759.65
32513308-251330859.04559.14
42523540-252354059.28559.38
52495811-249581158.63458.72
62357374-235737455.38255.47
20min12941967-294196769.11668.101.0569.3168.291.06
22893320-289332067.97368.17
32914651-291465168.47468.67
42909636-290963668.35668.55
52879190-287919067.64167.83
62854300-285430067.05667.23
30min13399565-339956579.86679.260.6180.1779.570.60
23342094-334209478.51678.83
33380017-338001779.40779.72
43383932-338393279.49979.81
53359149-335914978.91679.22
63379139-337913979.38679.67
45min13753447-375344788.18088.542.2288.6288.982.20
23688756-368875686.66087.11
33743797-374379787.95388.39
43746209-374620988.01088.45
53749570-374957088.08988.52
63932169-393216992.37892.80
60min13969173-396917393.24892.711.1093.8493.301.09
23879264-387926491.13591.73
33940047-394004792.56393.15
43925597-392559792.22492.81
53956565-395656592.95293.53
64007361-400736194.14594.72
极限14089225-408922596.06896.111.2996.8196.851.27
24018066-401806694.39695.14
34069045-406904595.59496.34
44083114-408311495.92596.67
54108916-410891696.53197.26
64178129-417812998.15798.89
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
19.893810316383340638193583813824382340738200620.24
29.973832179383978038359800.15
单位质量响应值RSD%判断
386255.01384752.260.28数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1713881-71388116.66614.1720.7416.6714.1720.75
2436582-43658210.19310.19
3464738-46473810.85010.85
4720293-72029316.81616.82
5679535-67953515.86515.86
6626750-62675014.63214.63
10min11769353-176935341.30841.306.0741.3441.326.07
21623267-162326737.89737.91
31678273-167827339.18139.20
41925194-192519444.94644.97
51823567-182356742.57342.60
61794263-179426341.88941.91
15min12495941-249594158.27157.303.5658.3757.393.57
22309716-230971653.92354.00
32402414-240241456.08756.17
42559310-255931059.75059.85
52493468-249346858.21358.31
62465201-246520157.55357.65
20min12866114-286611466.91366.882.3867.1167.072.39
22752452-275245264.25964.43
32828239-282823966.02966.21
42947811-294781168.82069.02
52906351-290635167.85268.05
62887425-288742567.41067.60
30min13293624-329362476.89477.701.2277.2078.001.23
23281975-328197576.62276.90
33304788-330478877.15477.44
43383707-338370778.99779.31
53350147-335014778.21378.52
63354833-335483378.32378.62
45min13619580-361958084.50386.031.1984.9486.461.19
23660732-366073285.46485.87
33672002-367200285.72786.14
43741799-374179987.35787.81
53700122-370012286.38486.82
63716129-371612986.75787.19
60min13788660-378866088.45190.671.4189.0291.241.41
23874347-387434790.45191.00
33865839-386583990.25390.81
43928712-392871291.72092.31
53908369-390836991.24591.83
63937036-393703691.91592.49
极限13933889-393388991.84193.831.3592.5694.551.36
23998831-399883193.35794.06
33990408-399040893.16193.87
44074256-407425695.11895.87
54049993-404999394.55295.29
64066255-406625594.93195.66
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
19.891917150191552819137131911406190953819134670.17
29.971936144193209419341190.15
单位质量响应值RSD%判断
193474.92193993.880.19数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1451675-45167520.98321.8228.6520.9821.8228.65
2583515-58351527.10727.11
3569236-56923626.44426.44
4255721-25572111.88011.88
5375737-37573717.45517.46
6582601-58260127.06527.06
10min11015399-101539947.17147.289.0847.2147.329.09
21072084-107208449.80449.85
31093826-109382650.81450.86
4861683-86168340.03040.05
5964363-96436344.80044.83
61099559-109955951.08051.13
15min11312123-131212360.95561.293.2461.0761.403.27
21337805-133780562.14862.28
31358585-135858563.11463.24
41250390-125039058.08758.17
51294955-129495560.15860.26
61362074-136207463.27663.41
20min11497623-149762369.57370.061.5969.7970.281.61
21513998-151399870.33370.57
31540820-154082071.57971.81
41474199-147419968.48568.67
51495816-149581669.48969.69
61526181-152618170.89971.14
30min11730599-173059980.39681.001.0680.7381.331.07
21728627-172862780.30480.65
31777458-177745882.57382.93
41734831-173483180.59280.89
51739233-173923380.79781.12
61750518-175051881.32181.67
45min11916486-191648689.03189.971.0789.5090.441.07
21914523-191452388.94089.42
31970405-197040591.53692.03
41945275-194527590.36990.80
51934179-193417989.85390.31
61939678-193967890.10990.60
60min12004707-200470793.13094.131.1993.7494.741.19
22004957-200495793.14193.77
32067396-206739696.04296.69
42039880-203988094.76495.35
52022250-202225093.94594.55
62017605-201760593.72994.37
极限12060479-206047995.72096.770.9996.4997.550.98
22069588-206958896.14496.93
32118251-211825198.40499.21
42092348-209234897.20197.94
52083748-208374896.80197.56
62074292-207429296.36297.16
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
19.891928035192765219262611919206191842119239150.25
29.971940120193965719398880.02
单位质量响应值RSD%判断
194531.34194572.520.02数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1623295-62329528.83422.8219.0828.8322.8219.07
2477800-47780022.10322.10
3575349-57534926.61626.62
4472904-47290421.87721.88
5358097-35809716.56616.57
6452031-45203120.91120.91
10min11120019-112001951.81248.316.1951.8648.356.20
21050021-105002148.57448.61
31113343-111334351.50351.55
41017403-101740347.06547.10
5951020-95102043.99444.02
61014374-101437446.92546.96
15min11379691-137969163.82561.653.2463.9661.763.26
21332696-133269661.65161.77
31385906-138590664.11264.24
41312994-131299460.73960.85
51274992-127499258.98159.08
61309356-130935660.57160.68
20min11552624-155262471.82570.062.2772.0770.282.29
21512259-151225969.95770.18
31558681-155868172.10572.34
41497493-149749369.27469.49
51473503-147350368.16468.36
61491859-149185969.01469.23
30min11768756-176875681.82380.601.6382.1880.941.64
21739402-173940280.46580.80
31784547-178454782.55382.91
41721759-172175979.64979.98
51713866-171386679.28479.60
61725723-172572379.83280.16
45min11949987-194998790.20789.001.5090.7089.461.52
21918343-191834388.74389.21
31966590-196659090.97591.47
41908529-190852988.28988.75
51889294-188929487.39987.84
61910018-191001888.35888.82
60min12034489-203448994.11693.151.4594.7693.771.47
22002181-200218192.62193.24
32062940-206294095.43296.08
41996164-199616492.34392.95
51986344-198634491.88992.48
61999044-199904492.47693.09
极限12083230-208323096.37195.491.4597.1796.271.46
22056771-205677195.14795.92
32114588-211458897.82198.63
42052270-205227094.93895.70
52031467-203146793.97694.72
62047425-204742594.71495.48
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