氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151800631799821802881802381801091801360.07
214.181792601798011795300.22
单位质量响应值RSD%判断
12730.4612660.790.39数据可信
供试品溶液-2763566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%
2min126112-2611214.53821.7325.5814.5421.7325.57
240671-4067122.64422.64
330646-3064617.06217.06
438449-3844921.40721.41
554304-5430430.23430.23
644010-4401024.50324.50
5min1154252-15425285.88085.882.3285.8885.882.32
2152343-15234384.81784.82
3148743-14874382.81382.81
4158523-15852388.25888.26
5154035-15403585.75985.76
6157603-15760387.74687.75
10min1176250-17625098.12898.631.4898.1398.641.47
2174117-17411796.94096.94
3181559-181559101.083101.08
4178601-17860199.43699.44
5176788-17678898.42798.43
6175652-17565297.79597.79
15min1180051-180051100.244100.671.83100.24100.671.83
2178359-17835999.30299.30
3187185-187185104.216104.22
4181240-181240100.906100.91
5179730-179730100.065100.07
6178355-17835599.30099.30
20min1176480-17648098.256100.401.8098.26100.401.80
2178800-17880099.54799.55
3186066-186066103.593103.59
4181120-181120100.839100.84
5180476-180476100.480100.48
6179045-17904599.68499.68
30min1181245-181245100.909100.692.31100.91100.682.31
2178675-17867599.47899.48
3188835-188835105.134105.13
4176855-17685598.46498.46
5179854-179854100.134100.13
6179601-17960199.99399.99
45min1181238-181238100.905100.343.12100.90100.343.12
2181027-181027100.787100.79
3189027-189027105.241105.24
4171616-17161695.54895.55
5180328-180328100.398100.40
6178151-17815199.18699.19
60min1181470-181470101.034100.862.78101.03100.862.78
2178309-17830999.27499.27
3189364-189364105.429105.43
4182631-182631101.680101.68
5174187-17418796.97996.98
6180985-180985100.764100.76
极限1181519-181519101.061101.541.78101.06101.541.78
2180257-180257100.358100.36
3188724-188724105.072105.07
4182735-182735101.738101.74
5180537-180537100.514100.51
6180560-180560100.527100.53
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151794471802041797011807561797281799670.29
214.181814021815301814660.05
单位质量响应值RSD%判断
12718.5212797.320.44数据可信
供试品溶液-2763566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%
2min180171-8017144.41828.4735.2344.4228.4735.22
235193-3519319.49819.50
355288-5528830.63130.63
441635-4163523.06723.07
562367-6236734.55334.55
633621-3362118.62718.63
5min1167634-16763492.87586.876.0792.8886.876.07
2144964-14496480.31580.32
3163797-16379790.74990.75
4155507-15550786.15686.16
5162574-16257490.07290.07
6146282-14628281.04581.05
10min1179037-17903799.19397.382.1899.1997.382.18
2170998-17099894.73994.74
3172806-17280695.74195.74
4179243-17924399.30799.31
5179310-17931099.34499.34
6173214-17321495.96795.97
15min1179954-17995499.70199.421.3499.7099.421.34
2176146-17614697.59197.59
3179915-17991599.67999.68
4182035-182035100.854100.85
5181643-181643100.637100.64
6177023-17702398.07798.08
20min1181603-181603100.61499.801.57100.6199.801.57
2179712-17971299.56799.57
3180121-18012199.79399.79
4184112-184112102.004102.00
5179746-17974699.58699.59
6175502-17550297.23497.23
30min1180199-18019999.837100.081.4199.84100.081.41
2178061-17806198.65298.65
3180573-180573100.044100.04
4183284-183284101.546101.55
5183853-183853101.861101.86
6177809-17780998.51298.51
45min1182799-182799101.277100.531.83101.28100.541.83
2178355-17835598.81598.81
3180975-180975100.266100.27
4185149-185149102.579102.58
5184514-184514102.227102.23
6176963-17696398.04498.04
60min1181580-181580100.60299.981.56100.6099.981.57
2177812-17781298.51498.51
3181172-181172100.376100.38
4182559-182559101.144101.14
5183360-183360101.588101.59
6176222-17622297.63397.63
极限1181916-181916100.78899.781.79100.7999.781.80
2175672-17567297.32897.33
3181063-181063100.315100.32
4183071-183071101.428101.43
5182467-182467101.093101.09
6176401-17640197.73297.73
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