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%
110.151948644194781419478071948642194932719484470.04
210.251983775198395319838640.01
单位质量响应值RSD%判断
191965.22193547.710.59数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1794601-79460137.10142.2628.2237.1042.2628.22
21056517-105651749.33149.33
31037994-103799448.46648.47
41225817-122581757.23657.24
5503029-50302923.48723.49
6811997-81199737.91437.91
10min11634675-163467576.32680.278.2876.3980.348.29
21852842-185284286.51386.59
31806222-180622284.33684.42
41856482-185648286.68386.78
51504270-150427070.23770.28
61660128-166012877.51477.58
15min11985960-198596092.72893.362.8292.9293.562.84
22070106-207010696.65796.88
32025939-202593994.59594.82
42033078-203307894.92895.17
51909822-190982289.17389.33
61971545-197154592.05592.25
20min12102900-210290098.18897.711.3198.5398.061.33
22134144-213414499.647100.03
32100920-210092098.09698.47
42092366-209236697.69698.09
52058200-205820096.10196.41
62067021-206702196.51396.86
30min12149888-2149888100.38299.600.93100.89100.120.94
22163231-2163231101.005101.56
32133248-213324899.605100.15
42116445-211644598.82199.38
52121850-212185099.07399.54
62113758-211375898.69599.20
45min12145312-2145312100.16999.640.88100.84100.330.89
22164548-2164548101.067101.79
32136306-213630699.748100.46
42119965-211996598.98599.71
52123405-212340599.14699.78
62114676-211467698.73899.41
60min12141394-214139499.98699.450.85100.83100.300.86
22159283-2159283100.821101.71
32131975-213197599.546100.42
42114295-211429598.72099.61
52118242-211824298.90599.70
62114210-211421098.71699.55
极限12140142-214014299.92799.350.99100.94100.371.00
22163109-2163109101.000102.06
32128134-212813499.366100.41
42110188-211018898.52999.58
52116407-211640798.81999.78
62108480-210848098.44999.45
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%
110.151977856197828419776001978448197745819779290.03
210.251992598199268219926400.01
单位质量响应值RSD%判断
194869.85194403.900.17数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1888194-88819441.07043.5917.7241.0743.5917.72
21080030-108003049.94149.94
3908542-90854242.01142.01
41147391-114739153.05553.06
5670373-67037330.99831.00
6961732-96173244.47144.47
10min11777379-177737982.18681.224.1882.2581.294.19
21801472-180147283.30083.38
31712370-171237079.18079.25
41832694-183269484.74484.83
51630633-163063375.40175.45
61784732-178473282.52682.60
15min12012822-201282293.07393.000.7293.2893.210.74
22011777-201177793.02593.25
32011692-201169293.02193.22
42030817-203081793.90594.13
51986072-198607291.83692.01
62014479-201447993.15093.36
20min12088216-208821696.55996.650.5096.9297.010.49
22075273-207527395.96196.34
32105014-210501497.33697.69
42096166-209616696.92797.31
52092169-209216996.74297.07
62083796-208379696.35596.72
30min12126606-212660698.33498.260.7398.8698.790.72
22102900-210290097.23897.78
32145453-214545399.20699.73
42124423-212442398.23398.78
52137408-213740898.83499.33
62113594-211359497.73398.26
45min12127375-212737598.37098.290.8399.0698.980.81
22102006-210200697.19797.90
32149932-214993299.413100.10
42125528-212552898.28499.00
52138267-213826798.87499.53
62110686-211068697.59898.29
60min12120206-212020698.03898.030.8498.8998.880.82
22098354-209835497.02897.89
32144658-214465899.169100.02
42118021-211802197.93798.81
52134840-213484098.71599.54
62104019-210401997.29098.14
极限12120216-212021698.03998.010.7499.0599.030.73
22096309-209630996.93397.96
32142684-214268499.078100.09
42117561-211756197.91698.95
52129030-212903098.44699.43
62112101-211210197.66498.68
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%
110.151973936197365719727491972801197023719726760.08
210.252008493200888920086910.02
单位质量响应值RSD%判断
194352.32195969.850.59数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11062316-106231648.99049.549.0248.9949.549.02
2953052-95305243.95143.95
3964452-96445244.47744.48
41165671-116567153.75753.76
51139564-113956452.55352.55
61160036-116003653.49753.50
10min11858919-185891985.72785.332.6885.8185.412.68
21775374-177537481.87481.95
31802950-180295083.14683.22
41885318-188531886.94487.03
51889404-188940487.13387.22
61889697-188969787.14687.24
15min12086820-208682096.23795.920.8696.4696.140.87
22053512-205351294.70194.91
32065900-206590095.27295.48
42080152-208015295.92996.16
52089761-208976196.37396.61
62103499-210349997.00697.24
20min12136256-213625698.51798.430.5798.9098.820.57
22119155-211915597.72898.10
32129336-212933698.19898.57
42131642-213164298.30498.70
52134683-213468398.44498.84
62155737-215573799.41599.81
30min12153151-215315199.29699.230.4899.8499.780.49
22139498-213949898.66699.20
32149591-214959199.13299.67
42144581-214458198.90199.46
52153368-215336899.30699.86
62169692-2169692100.059100.62
45min12147732-214773299.04699.030.6099.7699.750.60
22133912-213391298.40999.10
32143765-214376598.86399.56
42140766-214076698.72599.45
52147521-214752199.03699.76
62171186-2171186100.128100.86
60min12142378-214237898.79998.740.4899.6899.620.48
22128644-212864498.16699.02
32137570-213757098.57799.44
42136832-213683298.54399.43
52141987-214198798.78199.67
62159049-215904999.568100.46
极限12138286-213828698.61098.540.5599.6599.580.55
22124984-212498497.99799.02
32134241-213424198.42499.45
42128101-212810198.14199.19
52136638-213663898.53499.59
62157889-215788999.514100.58
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%
110.152003466200348520033932003254200048820028170.07
210.252028188202849920283440.02
单位质量响应值RSD%判断
197321.87197887.220.21数据可信
稳定性36月-长期36月-供试品溶液-2011707批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1941985-94198542.90344.2711.2742.9044.2611.26
21176712-117671253.59453.59
3968113-96811344.09344.09
4976076-97607644.45644.46
5855313-85531338.95638.96
6913245-91324541.59441.59
10min11795900-179590081.79582.792.7481.8782.862.75
21893529-189352986.24286.33
31858574-185857484.65084.72
41774903-177490380.83980.91
51766073-176607380.43780.50
61817374-181737482.77382.84
15min12063853-206385393.99994.640.9094.2194.850.91
22105445-210544595.89496.13
32093437-209343795.34795.56
42080646-208064694.76494.97
52064765-206476594.04194.24
62059559-205955993.80494.01
20min12131450-213145097.07897.451.1797.4497.821.17
22161667-216166798.45498.85
32149974-214997497.92298.30
42168809-216880998.78099.15
52105168-210516895.88196.24
62120023-212002396.55896.92
30min12154804-215480498.14298.471.1098.6799.001.11
22176893-217689399.14899.70
32170822-217082298.87199.41
42195293-219529399.986100.52
52130347-213034797.02897.54
62143447-214344797.62598.15
45min12150013-215001397.92498.301.1198.6199.001.12
22172528-217252898.94999.67
32167493-216749398.72099.42
42192480-219248099.858100.56
52125564-212556496.81097.49
62141915-214191597.55598.24
60min12151052-215105297.97198.041.0998.8298.901.09
22165177-216517798.61499.50
32160977-216097798.42399.29
42184694-218469499.503100.37
52120037-212003796.55897.40
62132846-213284697.14297.99
极限12142381-214238197.57697.731.0698.5998.751.07
22159734-215973498.36699.42
32153750-215375098.09499.12
42175343-217534399.077100.11
52110438-211043896.12197.12
62132443-213244397.12398.14
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