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4000
标示量(mg)2.5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%
119.231010891013501015801011701014461013270.20
219.221013571017341015460.27
单位质量响应值RSD%判断
5269.215283.350.19数据可信
供试品溶液-YBA2147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%
5min182544-8254479.91378.093.8679.9178.093.86
278658-7865876.15076.15
375325-7532572.92472.92
481268-8126878.67778.68
583430-8343080.77080.77
682724-8272480.08780.09
10min1103795-103795100.486103.042.08100.62103.172.08
2108161-108161104.713104.84
3105300-105300101.943102.06
4107151-107151103.735103.87
5109537-109537106.045106.18
6104677-104677101.340101.47
15min1103969-103969100.655103.021.98100.96103.321.98
2108587-108587105.125105.43
3105602-105602102.236102.53
4106786-106786103.382103.69
5109023-109023105.548105.86
6104483-104483101.152101.45
20min1103376-103376100.081102.752.00100.55103.221.99
2108080-108080104.635105.11
3105512-105512102.148102.61
4106572-106572103.175103.65
5108846-108846105.376105.86
6104386-104386101.058101.53
30min1103680-103680100.375102.572.03101.01103.212.02
2108438-108438104.981105.63
3104811-104811101.470102.10
4106119-106119102.736103.38
5108546-108546105.086105.75
6104075-104075100.757101.40
45min1103173-10317399.884102.422.01100.69103.242.00
2107955-107955104.514105.34
3105408-105408102.048102.85
4105900-105900102.524103.34
5108454-108454104.997105.83
6103878-103878100.567101.37
极限1102954-10295499.672102.902.01100.64103.892.00
2107403-107403103.979104.98
3104807-104807101.466102.44
4106010-106010102.631103.62
5108331-108331104.878105.89
6108243-108243104.792105.77
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4000
标示量(mg)2.5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%
119.231011551009911012761009701015851011950.25
219.221006271006721006500.04
单位质量响应值RSD%判断
5262.355236.730.35数据可信
供试品溶液-YBA2147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%
5min172819-7281970.85776.799.8470.8676.809.84
292711-9271190.21390.21
374197-7419772.19872.20
473291-7329171.31671.32
583100-8310080.86180.86
677403-7740375.31875.32
10min1105453-105453102.612102.160.96102.73102.290.95
2103540-103540100.750100.90
3106090-106090103.232103.35
4105878-105878103.025103.14
5104164-104164101.358101.49
6104836-104836102.011102.14
15min1105678-105678102.831102.170.96103.12102.470.95
2103491-103491100.703101.02
3106115-106115103.256103.55
4105604-105604102.759103.05
5104152-104152101.346101.65
6104972-104972102.144102.44
20min1105630-105630102.784102.051.09103.24102.521.07
2103128-103128100.349100.84
3106211-106211103.349103.81
4105571-105571102.727103.19
5104238-104238101.430101.90
6104474-104474101.659102.12
30min1105929-105929103.075101.921.03103.71102.561.02
2103021-103021100.245100.90
3105636-105636102.790103.43
4105158-105158102.325102.96
5104115-104115101.310101.95
6104590-104590101.772102.41
45min1108981-108981106.045102.212.03106.85103.022.01
2102816-102816100.046100.87
3105407-105407102.567103.38
4104907-104907102.081102.88
5103794-103794100.997101.81
6104331-104331101.520102.32
极限1105936-105936103.082101.621.25104.06102.601.24
2102485-10248599.724100.71
3105572-105572102.728103.71
4104829-104829102.005102.98
5103450-103450100.663101.64
6104359-104359101.547102.52
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4000
标示量(mg)2.5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%
119.231014371011431013311012491012831012890.11
219.221008451008741008600.03
单位质量响应值RSD%判断
5267.245247.660.27数据可信
供试品溶液-YBA2147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%
5min178058-7805875.84077.934.1575.8477.934.15
282971-8297180.61480.61
379170-7917076.92176.92
482952-8295280.59580.60
583016-8301680.65880.66
675058-7505872.92672.93
10min1104071-104071101.114102.111.51101.24102.241.51
2102598-10259899.68399.82
3104997-104997102.014102.14
4105888-105888102.880103.01
5107047-107047104.006104.14
6105997-105997102.986103.11
15min1104822-104822101.844102.401.53102.14102.701.53
2102552-10255299.63999.94
3105413-105413102.418102.72
4106084-106084103.070103.38
5107163-107163104.119104.43
6106338-106338103.317103.61
20min1104604-104604101.632102.321.43102.10102.801.43
2102795-10279599.875100.34
3105303-105303102.311102.78
4105847-105847102.840103.32
5107128-107128104.085104.57
6106223-106223103.205103.67
30min1104109-104109101.151102.141.51101.79102.781.50
2102667-10266799.750100.38
3105117-105117102.131102.77
4105713-105713102.710103.36
5107220-107220104.174104.83
6105919-105919102.910103.55
45min1104055-104055101.099102.131.64101.90102.941.63
2102365-10236599.457100.26
3105320-105320102.328103.14
4105632-105632102.631103.45
5107362-107362104.312105.14
6105941-105941102.931103.74
极限1104468-104468101.500101.911.30102.47102.901.30
2102576-10257699.662100.63
3104850-104850101.871102.85
4105267-105267102.276103.27
5106665-106665103.635104.64
6105542-105542102.544103.52
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