非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.153898443390127438992893902900390313739010090.06
210.193884337388506738847020.02
单位质量响应值RSD%判断
384335.86381226.890.58数据可信
供试品溶液-2024091313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%
5min1783664-78366418.42619.7414.3018.4319.7414.30
2986369-98636923.19223.19
3687697-68769716.16916.17
4938171-93817122.05922.06
5903127-90312721.23521.23
6737075-73707517.33017.33
10min11938710-193871045.58449.715.9145.6249.755.92
22228962-222896252.40852.46
32186690-218669051.41551.45
42175146-217514651.14351.19
52183006-218300651.32851.38
61971758-197175846.36146.40
15min12570121-257012160.43063.562.6360.5763.722.64
22762840-276284064.96165.13
32745991-274599164.56564.72
42733762-273376264.27864.44
52728106-272810664.14564.31
62679255-267925562.99663.14
20min12925338-292533868.78269.363.1269.0669.663.11
23040051-304005171.47971.79
32781587-278158765.40265.70
43008599-300859970.74071.05
52990942-299094270.32570.63
62954178-295417869.46069.74
30min13298536-329853677.55777.990.6177.9978.440.61
23309803-330980377.82278.29
33321217-332121778.09078.53
43344618-334461878.64079.10
53333748-333374878.38578.84
63293587-329358777.44077.88
45min13574544-357454484.04684.110.6184.6584.730.61
23571664-357166483.97984.62
33578542-357854284.14084.75
43618297-361829785.07585.71
53566173-356617383.85084.48
63554927-355492783.58584.19
60min13722440-372244087.52487.770.6088.3188.580.60
23725265-372526587.59088.42
33741597-374159787.97488.77
43774160-377416088.74089.57
53712944-371294487.30188.12
63722130-372213087.51788.31
极限13864591-386459190.86691.311.0191.8592.321.00
23842409-384240990.34591.37
33951546-395154692.91193.91
43905001-390500191.81692.84
53872442-387244291.05192.07
63865694-386569490.89291.88
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.153893950389321338920123891687389137438924470.03
210.193967584396992939687560.05
单位质量响应值RSD%判断
383492.32389475.561.10数据可信
供试品溶液-2024091313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%
5min1656023-65602315.27820.4024.5715.2820.4024.56
2710128-71012816.53816.54
3675731-67573115.73715.74
41100697-110069725.63325.63
51059879-105987924.68324.68
61052557-105255724.51224.51
10min12028416-202841647.23848.798.1147.2748.848.13
21872879-187287943.61643.65
31942346-194234645.23445.27
42279208-227920853.07953.14
52231677-223167751.97252.03
62215505-221550551.59551.65
15min12606140-260614060.69262.493.6960.8362.653.72
22587945-258794560.26960.40
32590008-259000860.31760.45
42801145-280114565.23465.41
52768569-276856964.47564.65
62746786-274678663.96864.14
20min12929947-292994768.23369.772.2368.5170.062.26
22943788-294378868.55668.82
32932530-293253068.29468.56
43070722-307072271.51271.83
53048184-304818470.98771.30
63049269-304926971.01271.32
30min13282140-328214076.43577.561.4376.8678.011.46
23306026-330602676.99277.41
33284435-328443576.48976.91
43399466-339946679.16879.65
53366332-336633278.39678.87
63345102-334510277.90278.37
45min13564778-356477883.01783.901.1083.6184.521.12
23580343-358034383.38083.97
33564753-356475383.01783.61
43661799-366179985.27785.93
53627903-362790384.48885.13
63617395-361739584.24384.89
60min13735959-373595987.00487.831.2587.7888.641.27
23752504-375250487.38988.17
33736874-373687487.02587.80
43853111-385311189.73290.58
53801926-380192688.54089.37
63747862-374786287.28188.11
极限13867794-386779490.07490.530.7291.0591.530.74
23876852-387685290.28591.26
33872334-387233490.18091.15
43940214-394021491.76192.80
53896493-389649390.74391.77
63870728-387072890.14391.17
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.151946283194801219486201942097194555819461140.14
210.191941738194027519410060.06
单位质量响应值RSD%判断
191735.37190481.450.47数据可信
供试品溶液-2024092211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%
5min1524570-52457024.70429.2111.1724.7029.2011.17
2658360-65836031.00531.00
3603029-60302928.39928.40
4604891-60489128.48728.49
5731386-73138634.44434.44
6598623-59862328.19228.19
10min11100757-110075751.83957.805.3951.8957.865.39
21224925-122492557.68757.76
31256117-125611759.15659.22
41263519-126351959.50459.57
51287529-128752960.63560.71
61231150-123115057.98058.04
15min11403575-140357566.10068.162.5766.2768.362.58
21442107-144210767.91568.11
31480100-148010069.70469.90
41415764-141576466.67466.87
51500630-150063070.67170.88
61442231-144223167.92168.11
20min11556848-155684873.31974.101.8273.6474.441.83
21567141-156714173.80374.15
31600833-160083375.39075.74
41537386-153738672.40272.75
51613752-161375275.99876.37
61564148-156414873.66274.00
30min11710644-171064480.56180.901.6681.0481.411.66
21707671-170767180.42180.93
31742646-174264682.06982.59
41675387-167538778.90179.41
51755788-175578882.68783.22
61715156-171515680.77481.28
45min11829145-182914586.14286.371.6886.8087.061.69
21824370-182437085.91786.61
31860112-186011287.60088.30
41789045-178904584.25484.93
51876670-187667088.38089.10
61824621-182462185.92986.61
60min11890886-189088689.05089.281.4789.9090.161.47
21882296-188229688.64589.53
31919849-191984990.41491.31
41855473-185547387.38288.25
51933638-193363891.06391.98
61892584-189258489.13090.01
极限11947923-194792391.73691.991.5492.7893.081.55
21945150-194515091.60592.68
31981373-198137393.31194.41
41907337-190733789.82590.89
51991745-199174593.80094.92
61946994-194699491.69292.77
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.151922734192397119234741921760192144719226770.06
210.191972247197097719716120.05
单位质量响应值RSD%判断
189426.31193484.991.50数据可信
供试品溶液-2024092211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%
5min1606205-60620528.50029.525.3328.5029.525.33
2625564-62556429.41029.41
3672554-67255431.61931.62
4597712-59771228.10128.10
5665828-66582831.30331.30
6599946-59994628.20628.21
10min11187087-118708755.80957.052.9255.8757.122.92
21233530-123353057.99358.06
31178297-117829755.39655.47
41182543-118254355.59655.66
51237161-123716158.16358.23
61262553-126255359.35759.42
15min11426857-142685767.08267.901.7567.2768.091.75
21463091-146309168.78568.98
31434312-143431267.43267.63
41419815-141981566.75166.94
51486073-148607369.86670.06
61435388-143538867.48367.68
20min11574173-157417374.00773.970.9174.3474.320.91
21586941-158694174.60874.95
31564987-156498773.57673.92
41555964-155596473.15173.49
51565429-156542973.59673.95
61593198-159319874.90275.25
30min11696545-169654579.76180.561.5580.2681.071.55
21753410-175341082.43482.95
31705110-170511080.16380.67
41720607-172060780.89281.39
51677540-167754078.86779.38
61728341-172834181.25581.77
45min11829729-182972986.02286.412.1986.7087.102.17
21805697-180569784.89285.59
31915198-191519890.04090.73
41816738-181673885.41186.09
51815608-181560885.35886.05
61844583-184458386.72087.41
60min11883169-188316988.53489.240.9389.4090.120.92
21926444-192644490.56991.45
31893143-189314389.00389.89
41909809-190980989.78790.65
51879486-187948688.36189.24
61897617-189761789.21490.10
极限11952587-195258791.79891.810.9492.8692.890.93
21983038-198303893.23094.32
31930868-193086890.77791.86
41955578-195557891.93993.00
51958134-195813492.05993.14
61937269-193726991.07892.16
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