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%
110.191956481195915019635071964534195811519603570.18
210.281974713197496519748390.01
单位质量响应值RSD%判断
192380.47192104.960.11数据可信
供试品溶液-2024092212批-pH4.5(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%
5min1204713-2047139.58417.7843.659.5817.7843.64
2471055-47105522.05322.05
3520653-52065324.37524.37
4150484-1504847.0457.05
5391302-39130218.31918.32
6540478-54047825.30325.30
10min1812953-81295338.05949.8523.9938.0849.8924.01
21257378-125737858.86558.91
31263546-126354659.15459.21
4674469-67446931.57631.59
51155565-115556554.09954.14
61224883-122488357.34457.40
15min11334569-133456962.47967.0511.5962.5867.2011.63
21584217-158421774.16674.35
31520300-152030071.17471.36
41139520-113952053.34853.43
51494883-149488369.98470.15
61519933-151993371.15771.34
20min11520797-152079771.19774.326.7071.4474.626.75
21699097-169909779.54579.89
31637842-163784276.67777.02
41405407-140540765.79566.00
51627704-162770476.20276.52
61634373-163437376.51576.86
30min11695851-169585179.39382.412.6079.8082.882.66
21828445-182844585.60086.12
31775916-177591683.14183.66
41724627-172462780.74081.09
51770366-177036682.88183.37
61766426-176642682.69783.21
45min11798493-179849384.19887.662.4184.7888.302.44
21939723-193972390.81091.52
31873101-187310187.69188.39
41869526-186952687.52388.05
51883191-188319188.16388.83
61870062-187006287.54988.24
60min11853163-185316386.75790.012.3887.5290.852.40
21991694-199169493.24394.16
31925063-192506390.12391.02
41929851-192985190.34891.07
51936496-193649690.65991.52
61899487-189948788.92689.82
极限11903445-190344589.11192.182.0290.0793.222.06
22026878-202687894.89096.01
31962675-196267591.88492.98
41966326-196632692.05592.98
51983240-198324092.84793.91
61971499-197149992.29793.39
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%
110.191962477196390619588411956435195284419589010.23
210.281990677198426219874700.23
单位质量响应值RSD%判断
192237.59193333.660.41数据可信
供试品溶液-2024092212批-pH4.5(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%
5min1528222-52822224.66011.8358.5624.6611.8258.57
2253258-25325811.82311.82
3131801-1318016.1536.15
4179735-1797358.3918.39
5139001-1390016.4896.49
6287965-28796513.44313.44
10min11240307-124030757.90340.1028.6757.9640.1228.69
2896023-89602341.83041.86
3614192-61419228.67328.69
4710729-71072933.18033.20
5653620-65362030.51430.53
61038497-103849748.48248.51
15min11514812-151481270.71860.8311.8370.9060.9411.87
21381871-138187164.51264.63
31122378-112237852.39752.47
41205823-120582356.29356.39
51183742-118374255.26255.34
61409279-140927965.79165.93
20min11632668-163266876.22071.724.7476.5671.974.79
21583513-158351373.92574.19
31430297-143029766.77266.97
41488061-148806169.46969.69
51516268-151626870.78670.99
61567130-156713073.16073.44
30min11762024-176202482.25981.891.5782.7782.301.59
21772765-177276582.76083.19
31730395-173039580.78281.12
41717916-171791680.20080.57
51792522-179252283.68384.05
61749011-174901181.65182.10
45min11880374-188037487.78487.831.9988.4888.421.97
21900680-190068088.73289.34
31867779-186777987.19687.72
41841218-184121885.95686.51
51944896-194489690.79691.34
61853262-185326286.51887.15
60min11933030-193303090.24290.482.0091.1391.271.97
21953833-195383391.21392.02
31935441-193544190.35591.07
41891677-189167788.31289.05
52003757-200375793.54494.29
61911472-191147289.23690.06
极限11958653-195865391.43892.222.5292.5393.222.48
21983798-198379892.61293.62
31966618-196661891.81092.73
41924821-192482189.85990.80
52068753-206875396.57897.54
61950293-195029391.04892.07
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%
110.191953597195534719545731954562195168419539530.08
210.281999594199755919985760.08
单位质量响应值RSD%判断
191752.01194414.010.98数据可信
供试品溶液-2024092213批-pH4.5(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%
5min1170906-1709067.96711.3950.277.9711.3950.26
2166946-1669467.7827.78
3122819-1228195.7255.73
4211186-2111869.8449.84
5368779-36877917.19017.19
6425076-42507619.81519.81
10min1717568-71756833.44939.5725.4333.4739.6025.45
2724348-72434833.76533.78
3605196-60519628.21128.22
4819409-81940938.19638.22
51119073-111907352.16552.20
61107687-110768751.63451.68
15min11212636-121263656.52660.5913.3556.6260.7013.38
21184517-118451755.21555.31
31101513-110151351.34651.42
41279691-127969159.65259.76
51535349-153534971.56971.72
61484983-148498369.22169.38
20min11508781-150878170.33172.126.1470.5572.376.19
21481950-148195069.08069.30
31432569-143256966.77866.97
41537293-153729371.66071.90
51670008-167000877.84678.16
61651960-165196077.00577.32
30min11739760-173976081.09882.332.1981.4782.742.26
21738506-173850681.03981.41
31729793-172979380.63380.97
41764181-176418182.23682.63
51826380-182638085.13585.62
61798804-179880483.85084.33
45min11881447-188144787.70288.501.0788.2689.091.12
21881576-188157687.70888.26
31893348-189334888.25788.77
41897982-189798288.47389.05
51936153-193615390.25290.93
61900710-190071088.60089.27
60min11939486-193948690.40891.230.7791.1692.020.83
21948610-194861090.83391.58
31954825-195482591.12391.84
41950157-195015790.90591.68
51980290-198029092.31093.19
61969614-196961491.81292.68
极限11966110-196611091.64993.121.0692.6094.111.08
21994760-199476092.98493.93
32016630-201663094.00494.92
41982395-198239592.40893.39
52021509-202150994.23195.31
62004963-200496393.46094.53
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%
110.191980667198438319812951984999198627119835230.13
210.281996358199227219943150.15
单位质量响应值RSD%判断
194653.88193999.510.24数据可信
供试品溶液-2024092213批-pH4.5(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%
5min1436991-43699120.23917.7634.5620.2417.7634.55
2437109-43710920.24420.24
3136356-1363566.3156.32
4449296-44929620.80920.81
5337086-33708615.61215.61
6503839-50383923.33523.33
10min11225679-122567956.76649.0921.4556.8149.1321.46
21157718-115771853.61853.66
3695338-69533832.20432.22
41051733-105173348.71048.76
5911349-91134942.20842.24
61317386-131738661.01361.07
15min11563165-156316572.39666.8010.8972.5766.9410.92
21540523-154052371.34871.51
31203878-120387855.75655.84
41408856-140885665.25065.40
51327729-132772961.49261.62
61609473-160947374.54174.73
20min11689558-168955878.25075.315.5578.5875.605.59
21692158-169215878.37078.69
31501524-150152469.54169.75
41586986-158698673.49973.80
51557745-155774572.14572.41
61728460-172846080.05280.40
30min11827048-182704884.61883.102.6285.1283.562.67
21829561-182956184.73485.23
31741824-174182480.67181.03
41766342-176634281.80682.27
51750100-175010081.05481.48
61850891-185089185.72286.25
45min11928481-192848189.31588.252.0490.0188.902.10
21932323-193232389.49390.18
31851118-185111885.73286.28
41892882-189288287.66788.31
51875144-187514486.84587.45
61952950-195295090.44991.17
60min11972693-197269391.36390.761.7592.2691.601.81
21985762-198576291.96892.85
31915916-191591688.73489.47
41947803-194780390.21091.05
51930272-193027289.39890.20
62005393-200539392.87893.80
极限12007593-200759392.97992.581.2494.0793.631.30
22007257-200725792.96494.05
31974566-197456691.45092.38
42000812-200081292.66593.71
51968312-196831291.16092.16
62035899-203589994.29095.42
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