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%
119.641039051040081041031040761040201040220.08
219.701034131033891034010.02
单位质量响应值RSD%判断
5296.445248.780.64数据可信
供试品溶液-25022501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%
5min1101720-10172098.548100.882.4998.55100.882.49
2101608-10160898.43998.44
3104037-104037100.793100.79
4108010-108010104.642104.64
5103041-10304199.82899.83
6106368-106368103.051103.05
10min1102641-10264199.440102.422.5299.60102.592.52
2103179-10317999.961100.13
3106334-106334103.018103.19
4108906-108906105.510105.68
5104696-104696101.431101.60
6108539-108539105.154105.33
15min1103691-103691100.457102.452.12100.79102.792.12
2103293-103293100.072100.40
3106686-106686103.359103.70
4109026-109026105.626105.98
5104667-104667101.403101.74
6107127-107127103.786104.13
20min1102595-10259599.395102.202.3599.89102.702.35
2102942-10294299.732100.23
3106657-106657103.331103.84
4108862-108862105.467105.99
5104801-104801101.533102.04
6107052-107052103.713104.23
30min1102894-10289499.685101.972.19100.35102.652.19
2102836-10283699.629100.29
3106004-106004102.698103.38
4108751-108751105.359106.06
5104480-104480101.222101.90
6106567-106567103.244103.94
45min1101910-10191098.732101.562.3199.56102.402.31
2102602-10260299.402100.23
3105764-105764102.466103.32
4108233-108233104.858105.74
5104034-104034100.790101.63
6106407-106407103.089103.95
极限1102565-10256599.366101.692.15100.36102.712.16
2102422-10242299.228100.22
3105676-105676102.380103.41
4108026-108026104.657105.71
5104375-104375101.120102.13
6106701-106701103.373104.41
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%
119.641036651040601038941045991048001042040.46
219.701037681035771036720.14
单位质量响应值RSD%判断
5305.705262.540.58数据可信
供试品溶液-25022501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%
5min1104246-104246100.77599.912.29100.7799.912.29
2101479-10147998.10098.10
3103954-103954100.492100.49
4104354-104354100.879100.88
5106354-106354102.812102.81
699722-9972296.40196.40
10min1105265-105265101.760101.581.72101.93101.751.72
2102604-10260499.18799.35
3106180-106180102.644102.81
4105843-105843102.318102.49
5107314-107314103.740103.91
6103282-10328299.843100.00
15min1105617-105617102.100101.531.66102.44101.861.66
2102732-10273299.31199.64
3105551-105551102.036102.37
4105994-105994102.464102.80
5107166-107166103.597103.94
6103095-10309599.66299.99
20min1105237-105237101.733101.531.37102.24102.041.38
2103752-103752100.297100.79
3105450-105450101.939102.45
4105560-105560102.045102.55
5107106-107106103.539104.06
6103056-10305699.624100.12
30min1105412-105412101.902101.311.62102.58101.981.63
2102434-10243499.02399.68
3105563-105563102.048102.73
4105400-105400101.890102.57
5106905-106905103.345104.03
6103056-10305699.624100.28
45min1104894-104894101.401101.031.83102.25101.871.83
2101816-10181698.42699.25
3105430-105430101.919102.77
4105413-105413101.903102.75
5106855-106855103.297104.16
6102623-10262399.206100.03
极限1104770-104770101.281100.961.65102.30101.971.65
2101893-10189398.50099.49
3105753-105753102.231103.25
4104839-104839101.348102.37
5106445-106445102.900103.93
6102940-10294099.512100.50
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%
119.641037021038181038671042231039131039050.19
219.701034531034341034440.02
单位质量响应值RSD%判断
5290.485250.960.54数据可信
供试品溶液-25022501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%
5min1107761-107761104.437101.542.15104.44101.542.15
2106263-106263102.985102.99
3101764-10176498.62598.63
4103138-10313899.95799.96
5103765-103765100.564100.56
6105935-105935102.667102.67
10min1108435-108435105.090103.081.67105.26103.251.67
2107993-107993104.662104.83
3104663-104663101.435101.60
4104458-104458101.236101.40
5105250-105250102.004102.17
6107382-107382104.070104.24
15min1107999-107999104.668103.041.53105.02103.381.54
2108079-108079104.745105.09
3104505-104505101.282101.61
4105047-105047101.807102.14
5105069-105069101.828102.17
6107218-107218103.911104.26
20min1107818-107818104.492102.731.63105.02103.251.64
2107738-107738104.415104.94
3104484-104484101.261101.76
4104117-104117100.905101.41
5104763-104763101.532102.04
6107096-107096103.793104.31
30min1107437-107437104.123102.561.52104.82103.251.52
2107560-107560104.242104.94
3104547-104547101.322101.99
4104059-104059100.849101.52
5104572-104572101.346102.02
6106794-106794103.500104.19
45min1107833-107833104.507102.481.55105.38103.341.55
2107240-107240103.932104.80
3104359-104359101.140101.98
4104073-104073100.863101.70
5104502-104502101.279102.12
6106450-106450103.167104.03
极限1107516-107516104.200102.251.59105.25103.281.59
2106991-106991103.691104.73
3104196-104196100.982101.99
4103481-103481100.289101.30
5104451-104451101.229102.24
6106393-106393103.111104.15
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