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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552035287203424420339122032102203761720346320.10
210.722025248202520920252280.01
单位质量响应值RSD%判断
192856.11188920.521.46数据可信
供试品溶液-250601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%
5min11538150-153815072.45676.1914.2572.4676.1914.25
21894538-189453889.24489.24
31654585-165458577.94177.94
41423439-142343967.05267.05
51863633-186363387.78887.79
61329895-132989562.64662.65
10min12100080-210008098.92698.443.4099.0598.563.42
22157298-2157298101.621101.77
32127386-2127386100.212100.34
41987940-198794093.64493.76
52148513-2148513101.208101.35
62016706-201670694.99995.10
15min12175980-2175980102.501101.561.69102.79101.851.70
22178031-2178031102.598102.92
32158571-2158571101.681101.98
42083260-208326098.13498.40
52172573-2172573102.341102.66
62167189-2167189102.087102.35
20min12177826-2177826102.588101.681.63103.04102.141.64
22178439-2178439102.617103.11
32159355-2159355101.718102.18
42088634-208863498.38798.82
52169654-2169654102.203102.69
62177927-2177927102.593103.03
30min12177092-2177092102.554101.571.64103.18102.201.65
22176010-2176010102.503103.16
32157656-2157656101.638102.27
42085666-208566698.24798.84
52166420-2166420102.051102.71
62174644-2174644102.438103.04
45min12174590-2174590102.436101.481.65103.23102.281.65
22172589-2172589102.342103.17
32156123-2156123101.566102.37
42083589-208358998.14998.91
52164174-2164174101.945102.77
62174699-2174699102.441103.22
60min12169742-2169742102.208101.291.64103.18102.261.65
22169294-2169294102.186103.19
32152804-2152804101.410102.38
42079700-207970097.96698.89
52160165-2160165101.756102.75
62169564-2169564102.199103.14
极限12164789-2164789101.974101.081.61103.11102.221.61
22164488-2164488101.960103.13
32151825-2151825101.364102.51
42076702-207670297.82598.91
52153423-2153423101.439102.60
62163784-2163784101.927103.04
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552055382205625220556572053284205739520555940.08
210.722087592208741720875040.01
单位质量响应值RSD%判断
194843.03194729.850.05数据可信
供试品溶液-250601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%
5min11617148-161714874.64569.3512.2874.6469.3512.28
21728267-172826779.77479.77
31485821-148582168.58368.58
41563951-156395172.18972.19
51192504-119250455.04455.04
61426727-142672765.85565.86
10min12119940-211994097.85396.171.7397.9896.281.73
22078874-207887495.95796.09
32116633-211663397.70097.81
42063545-206354595.25095.37
52025071-202507193.47493.57
62096418-209641896.76796.88
15min12159485-215948599.67898.261.1599.9798.541.15
22108475-210847597.32497.62
32153663-215366399.40999.69
42098730-209873096.87497.15
52119106-211910697.81498.06
62133124-213312498.46198.73
20min12159101-215910199.66098.341.19100.1198.781.18
22106049-210604997.21297.67
32156458-215645899.53899.98
42099223-209922396.89697.34
52123542-212354298.01998.43
62138481-213848198.70999.14
30min12163780-216378099.87698.321.23100.5098.921.23
22107287-210728797.26997.89
32153954-215395499.423100.03
42096427-209642796.76797.37
52124000-212400098.04098.61
62135159-213515998.55599.15
45min12155405-215540599.49098.181.17100.2898.951.16
22102790-210279097.06197.84
32149309-214930999.20899.98
42094012-209401296.65697.42
52125319-212531998.10198.84
62135326-213532698.56399.33
60min12154376-215437699.44298.061.25100.3998.991.24
22100301-210030196.94697.89
32152639-215263999.362100.30
42089935-208993596.46897.39
52121231-212123197.91298.81
62128500-212850098.24899.18
极限12150037-215003799.24297.871.21100.3698.961.20
22095850-209585096.74197.84
32144520-214452098.987100.09
42086781-208678196.32297.41
52116879-211687997.71198.78
62127739-212773998.21399.30
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552061984206286320645252064981206357820635860.06
210.722056292205655820564250.01
单位质量响应值RSD%判断
195600.57191830.691.38数据可信
供试品溶液-250602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%
5min11590146-159014673.81181.567.3373.8181.567.33
21846457-184645785.70885.71
31787197-178719782.95882.96
41733121-173312180.44880.45
51646287-164628776.41776.42
61939023-193902390.00590.01
10min12084105-208410596.74099.021.6196.8699.151.62
22185357-2185357101.439101.58
32139264-213926499.30099.44
42126700-212670098.71798.85
52113557-211355798.10798.23
62150126-215012699.80499.95
15min12115530-211553098.198100.401.5198.48100.711.51
22214110-2214110102.774103.09
32169733-2169733100.714101.02
42173445-2173445100.887101.19
52147851-214785199.69899.99
62157603-2157603100.151100.47
20min12119249-211924998.371100.481.5098.82100.951.50
22214490-2214490102.792103.27
32171229-2171229100.784101.26
42180011-2180011101.191101.66
52146048-214604899.615100.07
62157582-2157582100.150100.63
30min12116919-211691998.263100.351.5898.87100.981.59
22214997-2214997102.815103.47
32169407-2169407100.699101.34
42179549-2179549101.170101.81
52139514-213951499.31299.93
62150795-215079599.835100.49
45min12119890-211989098.401100.361.5299.18101.171.52
22215381-2215381102.833103.66
32167857-2167857100.627101.43
42174836-2174836100.951101.76
52140046-214004699.336100.12
62155246-2155246100.042100.86
60min12113759-211375998.116100.041.6299.06101.011.62
22212842-2212842102.715103.71
32159090-2159090100.220101.20
42172273-2172273100.832101.80
52133764-213376499.045100.00
62139758-213975899.323100.31
极限12113494-211349498.10499.941.6099.21101.081.60
22209242-2209242102.548103.72
32159363-2159363100.233101.38
42167914-2167914100.630101.77
52124622-212462298.62099.74
62143319-214331999.488100.64
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552089773209208220864932080263207829120853800.29
210.722102450210380221031260.05
单位质量响应值RSD%判断
197666.35196187.130.54数据可信
供试品溶液-250602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%
5min11633062-163306274.56175.516.3074.5675.516.31
21484411-148441167.77467.77
31773584-177358480.97780.98
41611315-161131573.56873.57
51746188-174618879.72679.73
61674837-167483776.46876.47
10min12150818-215081898.20096.072.2798.3296.192.27
22037659-203765993.03493.15
32160187-216018798.62898.76
42120194-212019496.80296.92
52076108-207610894.78994.92
62079860-207986094.96195.09
15min12195497-2195497100.24097.691.96100.5397.981.96
22109835-210983596.32996.60
32179484-217948499.50999.81
42151562-215156298.23498.52
52099970-209997095.87996.17
62101543-210154395.95196.24
20min12188031-218803199.89997.671.92100.3598.121.92
22113508-211350896.49796.93
32183478-218347899.692100.16
42152741-215274198.28898.74
52098599-209859995.81696.27
62099304-209930495.84896.29
30min12191333-2191333100.05097.512.03100.6798.122.03
22109974-210997496.33696.92
32180248-218024899.544100.18
42145388-214538897.95298.56
52093545-209354595.58596.20
62093489-209348995.58396.19
45min12190268-2190268100.00297.502.00100.7998.282.00
22106862-210686296.19396.94
32178543-217854399.466100.26
42147444-214744498.04698.82
52092687-209268795.54696.32
62097610-209761095.77196.54
60min12182965-218296599.66897.351.94100.6298.281.94
22108406-210840696.26497.17
32174823-217482399.296100.26
42144387-214438797.90798.84
52087204-208720495.29696.22
62094883-209488395.64796.57
极限12185393-218539399.77997.231.94100.9098.331.94
22105233-210523396.11997.19
32171996-217199699.167100.30
42133137-213313797.39398.49
52088699-208869995.36496.45
62093280-209328095.57396.66
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552086010208289220799702079525207839020813570.15
210.722122845212185421223500.04
单位质量响应值RSD%判断
197285.02197980.410.25数据可信
供试品溶液-250603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%
5min11770778-177077880.55975.956.3480.5675.956.34
21522660-152266069.27169.27
31632402-163240274.26474.26
41804254-180425482.08282.08
51603749-160374972.96072.96
61683044-168304476.56876.57
10min12117412-211741296.32996.380.7696.4696.500.77
22106138-210613895.81695.93
32097008-209700895.40095.52
42142270-214227097.46097.60
52128663-212866396.84196.96
62119178-211917896.40996.54
15min12153608-215360897.97598.670.9098.2798.960.89
22200094-2200094100.090100.37
32169176-216917698.68498.97
42174700-217470098.93599.23
52171447-217144798.78799.07
62144059-214405997.54197.83
20min12154007-215400797.99498.780.7998.4599.230.78
22186949-218694999.49299.93
32185254-218525499.41599.86
42183381-218338199.33099.79
52170740-217074098.75599.20
62147615-214761597.70398.15
30min12157778-215777898.16598.730.8198.7999.350.80
22191555-219155599.702100.31
32179058-217905899.13399.75
42179714-217971499.16399.79
52170512-217051298.74499.36
62143211-214321197.50298.12
45min12150518-215051897.83598.620.8898.6299.400.87
22187372-218737299.511100.29
32185632-218563299.432100.21
42177363-217736399.05699.85
52163286-216328698.41699.19
62141864-214186497.44198.22
60min12144458-214445897.55998.690.6498.5199.640.63
22181548-218154899.247100.19
32175892-217589298.98999.93
42173583-217358398.88499.84
52162983-216298398.40299.34
62177605-217760599.067100.01
极限12158677-215867798.20698.501.0099.3299.610.99
22197519-219751999.973101.08
32176668-217666899.025100.13
42163253-216325398.41499.54
52161843-216184398.35099.45
62132572-213257297.01898.12
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