苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.959577995949958419586995967958810.09
219.009646596461964630.01
单位质量响应值RSD%判断
5059.685077.000.25数据可信
供试品溶液-YAB2177批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176980-7698077.58476.453.3877.5876.453.37
274512-7451275.09675.10
375178-7517875.76875.77
474218-7421874.80074.80
573698-7369874.27674.28
680530-8053081.16281.16
10min198288-9828899.05999.050.9199.1999.180.91
298633-9863399.40699.53
398532-9853299.30599.43
499632-99632100.413100.54
597302-9730298.06598.19
697270-9727098.03398.17
15min198319-9831999.09099.301.0199.3899.581.00
298941-9894199.717100.01
399036-9903699.813100.10
499959-99959100.743101.03
597452-9745298.21698.50
697430-9743098.19498.49
20min198467-9846799.23999.241.1199.7099.701.10
298810-9881099.585100.04
398676-9867699.45099.91
4100216-100216101.002101.46
597404-9740498.16898.62
697219-9721997.98198.44
30min198003-9800398.77298.881.0699.4099.511.06
298414-9841499.18699.81
398687-9868799.461100.08
499647-99647100.428101.06
597031-9703197.79298.41
696910-9691097.67098.30
45min197988-9798898.75698.890.9699.5599.680.96
298458-9845899.230100.02
398416-9841699.18899.98
499556-99556100.337101.13
597483-9748398.24799.03
696801-9680197.56098.35
极限197516-9751698.28198.551.0599.2399.501.05
298163-9816398.93399.89
398171-9817198.94199.90
499406-99406100.186101.15
596708-9670897.46698.41
696745-9674597.50498.45
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.959596495903959949599495672959050.15
219.009625596236962460.02
单位质量响应值RSD%判断
5060.955065.580.07数据可信
供试品溶液-YAB2177批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167186-6718667.78176.456.3167.7876.466.31
277454-7745478.13978.14
375645-7564576.31476.31
477550-7755078.23678.24
575246-7524675.91275.91
681625-8162582.34782.35
10min1102314-102314103.219101.342.72103.33101.472.72
297924-9792498.79198.92
399125-99125100.002100.13
4104442-104442105.366105.50
597497-9749798.36098.49
6101406-101406102.303102.44
15min1102552-102552103.460101.382.55103.74101.682.55
298543-9854399.41599.71
399059-9905999.936100.23
4104143-104143105.065105.37
597508-9750898.37198.66
6101156-101156102.051102.36
20min1102445-102445103.352101.322.54103.81101.792.54
298658-9865899.53199.99
398967-9896799.843100.30
4104177-104177105.099105.58
597450-9745098.31298.77
6100904-100904101.797102.27
30min1102591-102591103.499101.252.66104.13101.892.65
298090-9809098.95899.58
399011-9901199.887100.51
4104101-104101105.022105.68
597362-9736298.22498.84
6101034-101034101.928102.58
45min1102412-102412103.318100.922.67104.12101.732.66
298109-9810998.97799.77
398754-9875499.628100.42
4103739-103739104.657105.49
596786-9678697.64398.42
6100436-100436101.325102.14
极限1101928-101928102.830100.822.63103.80101.792.63
298115-9811598.98399.94
398376-9837699.247100.21
4104044-104044104.965105.97
597130-9713097.99098.93
6100022-100022100.907101.89
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.959578495923958129581695780958230.07
219.009632896421963740.07
单位质量响应值RSD%判断
5056.625072.320.22数据可信
供试品溶液-YAB2177批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174424-7442475.06572.564.3175.0672.564.31
271531-7153172.14772.15
374961-7496175.60775.61
470206-7020670.81170.81
566817-6681767.39267.39
673708-7370874.34374.34
10min199106-9910699.96099.490.80100.0899.610.81
297822-9782298.66498.78
399190-99190100.044100.17
497455-9745598.29498.41
599227-99227100.082100.19
699054-9905499.907100.03
15min1100055-100055100.917100.000.85101.21100.290.85
298146-9814698.99199.28
399466-99466100.323100.62
498069-9806998.91499.20
599750-99750100.609100.89
699382-99382100.238100.53
20min199650-99650100.50899.880.77100.97100.340.77
298115-9811598.96099.41
399209-99209100.063100.52
498061-9806198.90699.35
599770-99770100.629101.08
699365-99365100.221100.68
30min199529-99529100.38699.660.86101.01100.280.86
297975-9797598.81999.43
399018-9901899.871100.50
497542-9754298.38298.99
599471-99471100.328100.94
699299-99299100.154100.78
45min199353-99353100.20999.430.81101.00100.220.81
297686-9768698.52799.31
398728-9872899.578100.37
497512-9751298.35299.13
599089-9908999.942100.72
699143-9914399.997100.79
极限198843-9884399.69499.140.87100.66100.090.87
297170-9717098.00798.95
398563-9856399.412100.37
497274-9727498.11299.05
599095-9909599.948100.90
698810-9881099.661100.62
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.959543695534956099542095519955040.09
219.009585395926958900.06
单位质量响应值RSD%判断
5039.795046.840.10数据可信
供试品溶液-YAB2177批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163058-6305863.86873.577.4963.8773.577.49
274638-7463875.59675.60
377787-7778778.78678.79
472223-7222373.15073.15
570792-7079271.70171.70
677311-7731178.30478.30
10min196782-9678298.02599.311.4998.1399.431.50
297296-9729698.54598.67
399128-99128100.401100.53
496915-9691598.15998.28
597699-9769998.95499.07
6100479-100479101.769101.90
15min197314-9731498.56499.651.3598.8399.941.35
297599-9759998.85299.14
399608-99608100.887101.19
497439-9743998.69098.98
597887-9788799.14499.43
6100462-100462101.752102.05
20min197116-9711698.36399.451.4298.8099.901.42
297364-9736498.61499.07
399573-99573100.852101.32
497269-9726998.51898.97
597483-9748398.73599.18
6100321-100321101.609102.08
30min196905-9690598.14999.261.2698.7599.881.26
297186-9718698.43499.05
399251-99251100.525101.16
497341-9734198.59199.21
597471-9747198.72399.34
699834-99834101.116101.76
45min196781-9678198.02499.301.3698.79100.081.36
297065-9706598.31199.09
399130-99130100.403101.21
496892-9689298.13698.91
598444-9844499.708100.49
699933-99933101.216102.02
极限196691-9669197.93398.991.2698.8699.941.27
297569-9756998.82299.77
398772-98772100.040101.01
496676-9667697.91798.86
597039-9703998.28599.23
699664-99664100.944101.92
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.959589995768956189593195566957560.18
219.009602396042960320.02
单位质量响应值RSD%判断
5053.095054.320.02数据可信
供试品溶液-YAB2177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%
5min179936-7993680.79684.177.7580.8084.177.75
275218-7521876.02776.03
385539-8553986.45986.46
492217-9221793.20993.21
578518-7851879.36379.36
688196-8819689.14589.14
10min196261-9626197.29798.892.6597.4399.032.65
2100929-100929102.015102.14
398738-9873899.80099.94
498095-9809599.15099.31
593579-9357994.58694.72
699400-99400100.469100.62
15min197088-9708898.13399.072.7798.4399.372.77
2101333-101333102.423102.72
398973-98973100.038100.35
497770-9777098.82299.14
593376-9337694.38194.67
699542-99542100.613100.93
20min196509-9650997.54798.762.6798.0199.232.66
2100968-100968102.054102.52
398677-9867799.739100.22
497762-9776298.81499.30
593340-9334094.34494.79
699011-99011100.076100.56
30min196445-9644597.48398.712.6698.1199.342.66
2100773-100773101.857102.49
398594-9859499.655100.30
497710-9771098.76199.41
593267-9326794.27094.87
699156-99156100.223100.87
45min196119-9611997.15398.572.8897.9499.372.88
2100853-100853101.938102.75
398563-9856399.623100.43
497563-9756398.61399.43
592799-9279993.79794.56
699223-99223100.291101.11
极限195836-9583696.86798.372.8897.8199.332.88
2100619-100619101.702102.68
398200-9820099.257100.23
497338-9733898.38599.36
592688-9268893.68594.60
699264-99264100.332101.32
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.959583195826958519581595926958500.05
219.009615596167961610.01
单位质量响应值RSD%判断
5058.055061.110.05数据可信
供试品溶液-YAB2177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%
5min175199-7519975.92078.115.2875.9278.105.28
279551-7955180.31480.31
382611-8261183.40383.40
472612-7261273.30873.31
573670-7367074.37674.38
680538-8053881.31081.31
10min197335-9733598.26898.981.5298.3999.121.52
2100995-100995101.963102.10
398117-9811799.05799.20
497158-9715898.08998.21
597259-9725998.19198.32
697404-9740498.33898.47
15min197603-9760398.53999.031.5998.8399.331.59
2101237-101237102.207102.51
397795-9779598.73299.04
497253-9725398.18598.47
597340-9734098.27398.56
697314-9731498.24798.55
20min197650-9765098.58698.851.5599.0499.311.55
2100943-100943101.911102.38
397594-9759498.52999.00
496909-9690997.83898.29
597065-9706597.99598.45
697287-9728798.22098.68
30min197711-9771198.64898.621.6699.2799.251.67
2100867-100867101.834102.48
397459-9745998.39399.03
496803-9680397.73198.34
596534-9653497.45998.07
696757-9675797.68498.31
45min197069-9706997.99998.511.6098.7899.301.61
2100707-100707101.672102.49
397387-9738798.32099.12
496641-9664197.56798.34
596663-9666397.59098.37
696968-9696897.89798.69
极限197041-9704197.97198.271.5798.9299.221.57
2100405-100405101.367102.35
396885-9688597.81498.77
496498-9649897.42398.36
596432-9643297.35698.30
696739-9673997.66698.62
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