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101278-202003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%
110.041934756193444319302751925114192312219295420.28
210.171994011199321419936120.03
单位质量响应值RSD%判断
192185.46196028.711.41数据可信
供试品溶液-2024112321批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11017191-101719147.16855.7314.2347.1755.7314.24
21020683-102068347.33047.33
31352518-135251862.71762.72
41279168-127916859.31659.32
51414181-141418165.57765.58
61127394-112739452.27852.28
10min11775135-177513582.31489.006.4582.4289.136.46
21827062-182706284.72284.83
32016984-201698493.52993.67
42039675-203967594.58194.71
52035918-203591894.40794.55
61821697-182169784.47384.59
15min11973468-197346891.51194.732.7291.8095.062.73
22042440-204244094.70995.00
32042838-204283894.72895.08
42117652-211765298.19798.54
52090314-209031496.92997.28
61991188-199118892.33392.64
20min12036362-203636294.42895.741.6494.9296.271.66
22053829-205382995.23795.74
32039499-203949994.57395.13
42118386-211838698.23198.79
52094815-209481597.13897.71
62045272-204527294.84195.35
30min12086046-208604696.73196.431.5597.4397.171.56
22057817-205781795.42296.14
32042234-204223494.70095.47
42127768-212776898.66699.44
52103357-210335797.53498.32
62060029-206002995.52596.24
45min12081932-208193296.54196.321.7297.4697.281.73
22049939-204993995.05795.98
32039714-203971494.58395.56
42131827-213182798.85499.85
52104459-210445997.58598.59
62055816-205581695.33096.26
60min12107002-210700297.70396.261.7398.8397.431.72
22046928-204692894.91796.06
32035410-203541094.38395.57
42123052-212305298.44799.66
52089738-208973896.90398.12
62052568-205256895.17996.32
极限12064470-206447095.73195.801.7997.0897.181.80
22034515-203451594.34295.69
32031133-203113394.18595.58
42129821-212982198.761100.20
52084151-208415196.64498.08
62051377-205137795.12496.48
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101278-202003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%
110.041967622196776519657141963796195904219647880.19
210.171984429198559619850120.05
单位质量响应值RSD%判断
195696.02195183.090.19数据可信
供试品溶液-2024112421批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11534287-153428770.65464.0822.9770.6564.0822.97
2988008-98800845.49845.50
31385009-138500963.78063.78
41110770-111077051.15151.15
51443730-144373066.48466.48
61887426-188742686.91686.92
10min12154667-215466799.22394.034.5299.3894.184.54
21892162-189216287.13487.24
32037140-203714093.81193.95
42000999-200099992.14692.26
52050223-205022394.41394.56
62116611-211661197.47097.66
15min12182629-2182629100.51097.971.92100.8998.321.92
22093328-209332896.39896.69
32102889-210288996.83897.19
42171393-217139399.993100.31
52088074-208807496.15696.51
62125904-212590497.89898.31
20min12181306-2181306100.44998.372.11101.0598.942.09
22118716-211871697.56798.08
32109576-210957697.14697.71
42200631-2200631101.339101.88
52084177-208417795.97796.55
62123013-212301397.76598.39
30min12175918-2175918100.20198.162.10101.0398.952.09
22116976-211697697.48798.21
32105051-210505196.93897.72
42196036-2196036101.128101.89
52079235-207923595.74996.53
62116405-211640597.46198.31
45min12121495-212149597.69598.302.0798.7499.312.08
22085160-208516096.02296.96
32196023-2196023101.127102.12
42105641-210564196.96597.96
52118100-211810097.53998.54
62181995-2181995100.481101.54
60min12116262-211626297.45498.042.0598.7299.262.05
22078597-207859795.72096.88
32192887-2192887100.983102.20
42100956-210095696.74997.96
52114220-211422097.36098.57
62170322-217032299.944101.23
极限12112070-211207097.26197.912.0398.7499.352.03
22075223-207522395.56496.93
32184924-2184924100.616102.06
42100112-210011296.71098.13
52112183-211218397.26698.70
62172321-2172321100.036101.54
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101278-202003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%
110.041951810195307619516321950877195087319516540.05
210.171984561198438019844700.01
单位质量响应值RSD%判断
194387.85195129.790.27数据可信
供试品溶液-2024112422批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11433656-143365666.25167.6215.6766.2567.6215.67
21309461-130946160.51260.51
31641754-164175475.86775.87
41115431-111543151.54551.55
51532333-153233370.81170.81
61747386-174738680.74980.75
10min12143760-214376099.06697.613.5499.2197.763.56
22113003-211300397.64497.78
32156380-215638099.64999.82
41964630-196463090.78890.90
52166212-2166212100.103100.26
62129711-212971198.41698.60
15min12175522-2175522100.533101.031.18100.90101.391.15
22186759-2186759101.053101.40
32170466-2170466100.300100.69
42223447-2223447102.748103.06
52207674-2207674102.019102.40
62153153-215315399.50099.90
20min12176384-2176384100.573101.201.41101.16101.791.38
22187002-2187002101.064101.64
32172877-2172877100.411101.02
42242702-2242702103.638104.18
52205765-2205765101.931102.54
62155203-215520399.594100.21
30min12176811-2176811100.593101.181.44101.41102.001.41
22185343-2185343100.987101.79
32169817-2169817100.270101.11
42242001-2242001103.605104.38
52208919-2208919102.077102.91
62154699-215469999.571100.41
45min12170311-2170311100.293101.011.56101.33102.061.53
22180171-2180171100.748101.77
32170208-2170208100.288101.35
42240701-2240701103.545104.55
52209300-2209300102.094103.15
62144796-214479699.114100.18
60min12162613-216261399.937100.691.67101.20101.961.64
22176333-2176333100.571101.82
32165747-2165747100.082101.36
42241979-2241979103.604104.84
52192232-2192232101.306102.59
62134601-213460198.64299.92
极限12161204-216120499.872100.521.45101.35102.011.42
22170222-2170222100.288101.76
32162617-216261799.937101.44
42228886-2228886102.999104.46
52191331-2191331101.264102.78
62137393-213739398.771100.27
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