塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.402812144280875928102922807664280611828089950.09
29.332805096280058728028420.12
单位质量响应值RSD%判断
298829.26300411.790.38数据可信
供试品溶液-24081301批-pH6.8(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%
5min1583734-58373419.40519.384.8019.4019.384.80
2620918-62091820.64120.64
3555567-55556718.46818.47
4604272-60427220.08720.09
5586338-58633819.49119.49
6547485-54748518.20018.20
10min11329421-132942144.19344.674.1744.2344.714.18
21352747-135274744.96845.01
31279607-127960742.53742.57
41433566-143356647.65547.70
51372316-137231645.61945.66
61294669-129466943.03843.07
15min11885019-188501962.66263.273.6862.7963.403.68
21902868-190286863.25663.39
31845895-184589561.36261.48
42028447-202844767.43067.57
51922836-192283663.91964.05
61834524-183452460.98461.11
20min12276259-227625975.66876.443.3675.9276.693.36
22294916-229491676.28876.55
32241041-224104174.49774.74
42444899-244489981.27481.54
52306648-230664876.67876.94
62232319-223231974.20774.45
30min12716875-271687590.31590.912.0190.7291.322.02
22747825-274782591.34491.75
32700913-270091389.78590.18
42835616-283561694.26294.70
52728421-272842190.69991.11
62678879-267887989.05289.44
45min12910085-291008596.73896.821.0197.3297.411.02
22909652-290965296.72397.32
32904798-290479896.56297.14
42959855-295985598.39299.01
52922315-292231597.14497.74
62869280-286928095.38195.95
60min12949604-294960498.05298.150.8298.8398.940.84
22955737-295573798.25599.04
32947277-294727797.97498.74
42989519-298951999.378100.20
52959377-295937798.37699.16
62914360-291436096.88097.64
极限12965985-296598598.59698.580.8299.5799.560.83
22964392-296439298.54399.53
32974808-297480898.88999.85
42996840-299684099.622100.64
52968284-296828498.67399.66
62922401-292240197.14798.10
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.402800532280040427965892797695279958427989610.07
29.332779092277876327789280.01
单位质量响应值RSD%判断
297761.81297848.660.03数据可信
供试品溶液-24081301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%
5min1486612-48661216.27515.2213.3316.2715.2213.34
2424246-42424614.18914.19
3404749-40474913.53713.54
4564079-56407918.86518.87
5414179-41417913.85213.85
6436317-43631714.59214.59
10min11152840-115284038.55636.389.3338.5936.419.34
21019150-101915034.08534.11
31014136-101413633.91733.94
41265517-126551742.32542.36
51021647-102164734.16934.20
61053612-105361235.23835.27
15min11666924-166692455.75052.796.6955.8652.896.70
21500839-150083950.19550.29
31497822-149782250.09450.19
41748400-174840058.47558.60
51502225-150222550.24150.34
61553728-155372851.96452.06
20min12044810-204481068.38865.544.8668.6165.754.87
21889554-188955463.19663.39
31887235-188723563.11863.31
42107807-210780770.49570.73
51884390-188439063.02363.22
61943919-194391965.01465.22
30min12513004-251300484.04781.892.6884.4082.232.70
22404671-240467180.42380.75
32393554-239355480.05280.37
42532882-253288284.71185.09
52378888-237888879.56179.88
62468430-246843082.55682.89
45min12758923-275892392.27191.991.1992.8092.501.19
22749261-274926191.94892.43
32716210-271621090.84391.32
42745610-274561091.82692.38
52725129-272512991.14191.62
62808736-280873693.93794.44
60min12828396-282839694.59594.931.4295.3195.621.40
22856195-285619595.52596.19
32809141-280914193.95194.61
42795948-279594893.51094.24
52832581-283258194.73595.40
62908411-290841197.27197.96
极限12890906-289090696.68596.641.2897.5997.511.27
22898058-289805896.92597.78
32850305-285030595.32896.18
42866955-286695595.88496.80
52874254-287425496.12896.98
62956073-295607398.86599.75
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.402794030279908927966582798509279842727973430.08
29.332800163280057528003690.02
单位质量响应值RSD%判断
297589.68300146.730.61数据可信
供试品溶液-24081301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%
5min1467716-46771615.58714.668.3315.5914.668.33
2414816-41481613.82413.82
3489789-48978916.32316.32
4453070-45307015.09915.10
5390943-39094313.02913.03
6423943-42394314.12814.13
10min11080181-108018135.99835.475.2436.0335.505.24
21046916-104691634.89034.92
31161116-116111638.69638.73
41042612-104261234.74634.78
5992665-99266533.08233.11
61061607-106160735.37935.41
15min11583309-158330952.76652.604.3152.8752.704.31
21571348-157134852.36752.46
31710021-171002156.98957.10
41534858-153485851.15151.25
51530033-153003350.99051.08
61541010-154101051.35651.46
20min11973576-197357665.77265.643.0765.9865.843.07
21960810-196081065.34765.55
32084207-208420769.45969.68
41933872-193387264.44964.65
51953709-195370965.11065.30
61910795-191079563.68063.88
30min12453163-245316381.75581.581.8282.1081.921.83
22446069-244606981.51981.85
32529353-252935384.29484.66
42432905-243290581.08081.41
52430824-243082481.01081.33
62395851-239585179.84580.17
45min12740587-274058791.33491.181.0291.8491.681.03
22733695-273369591.10491.60
32782288-278228892.72393.25
42733127-273312791.08591.58
52730038-273003890.98291.47
62695777-269577789.84090.33
60min12835559-283555994.49994.290.6795.1994.970.69
22825929-282592994.17894.86
32862071-286207195.38296.10
42818025-281802593.91494.59
52827318-282731894.22494.89
62806184-280618493.52094.19
极限12889960-288996096.31295.720.6897.1996.600.69
22879693-287969395.97096.84
32894853-289485396.47597.38
42855888-285588895.17696.04
52868403-286840395.59396.45
62845086-284508694.81695.67
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.402803152280128828003472802205279953028013040.06
29.332808815280737628080960.04
单位质量响应值RSD%判断
298011.06300974.920.70数据可信
供试品溶液-1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%
5min1341224-34122411.34810.539.4211.3510.539.41
2342428-34242811.38811.39
3284415-2844159.4599.46
4275005-2750059.1469.15
5336392-33639211.18711.19
6319846-31984610.63710.64
10min1881930-88193029.33027.136.7329.3527.156.73
2848500-84850028.21928.24
3766886-76688625.50425.52
4742049-74204924.67824.70
5855011-85501128.43528.46
6799931-79993126.60326.62
15min11346145-134614544.76941.954.9844.8542.034.98
21304902-130490243.39743.48
31212026-121202640.30840.38
41187987-118798739.50939.58
51296023-129602343.10243.18
61221910-122191040.63740.71
20min11744696-174469658.02354.973.8058.1955.133.80
21694891-169489156.36756.53
31630713-163071354.23354.38
41580394-158039452.55952.71
51672663-167266355.62855.79
61594664-159466453.03453.19
30min12234901-223490174.32672.492.4174.6172.762.41
22227924-222792474.09474.37
32155714-215571471.69371.95
42141791-214179171.23071.48
52211159-221115973.53773.81
62106552-210655270.05870.32
45min12638574-263857487.75186.721.7388.1987.141.73
22655514-265551488.31488.74
32587534-258753486.05486.46
42606134-260613486.67287.07
52627793-262779387.39387.82
62529827-252982784.13584.54
60min12772376-277237692.20191.961.1792.8192.551.18
22800997-280099793.15393.76
32740018-274001891.12591.70
42769962-276996292.12192.69
52792486-279248692.87093.47
62715278-271527890.30290.87
极限12832200-283220094.19194.211.2194.9994.981.22
22870403-287040395.46196.25
32807396-280739693.36694.12
42842786-284278694.54395.29
52863784-286378495.24196.03
62780392-278039292.46893.22
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