比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
111.131914181917621905531911591919361913660.29
211.031912311913491912900.05
单位质量响应值RSD%判断
17193.7117342.700.62数据可信
供试品溶液-3208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%
5min185505-8550544.38744.122.8144.3944.122.81
289112-8911246.25946.26
382377-8237742.76342.76
483279-8327943.23143.23
584012-8401243.61243.61
685604-8560444.43844.44
10min1130372-13037267.67865.732.3467.7565.812.34
2129013-12901366.97267.05
3122569-12256963.62763.70
4127394-12739466.13266.20
5124016-12401664.37864.45
6126410-12641065.62165.70
15min1156664-15666481.32680.333.1781.5180.523.16
2160545-16054583.34183.53
3147793-14779376.72176.90
4154084-15408479.98780.17
5150604-15060478.18178.36
6158798-15879882.43482.62
20min1169462-16946287.97086.441.4388.2986.761.43
2167232-16723286.81287.14
3164598-16459885.44585.75
4166819-16681986.59886.91
5162965-16296584.59784.91
6168059-16805987.24287.56
30min1179508-17950893.18592.641.4193.6593.101.41
2179976-17997693.42893.90
3177655-17765592.22392.67
4179124-17912492.98693.45
5173808-17380890.22690.68
6180728-18072893.81894.28
45min1184845-18484595.95695.961.5796.5896.571.57
2186789-18678996.96597.59
3184221-18422195.63296.23
4186277-18627796.69997.31
5179469-17946993.16593.77
6187488-18748897.32897.95
60min1186853-18685396.99898.142.1297.7898.922.11
2189203-18920398.21899.01
3187640-18764097.40798.17
4189506-18950698.37599.15
5184741-18474195.90296.66
6196399-196399101.953102.74
极限1188851-18885198.03598.171.7398.9899.111.72
2190044-19004498.65499.61
3189230-18923098.23299.15
4192543-19254399.952100.89
5183040-18304095.01995.94
6191003-19100399.152100.11
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
111.131913371912711910821913741908791911890.11
211.031917521917711917620.01
单位质量响应值RSD%判断
17177.8117385.490.85数据可信
供试品溶液-3208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%
5min183939-8393943.54142.422.4343.5442.422.43
281315-8131542.18042.18
379521-7952141.24941.25
480917-8091741.97341.97
580502-8050241.75841.76
684481-8448143.82243.82
10min1129782-12978267.32064.653.1767.3964.723.16
2119263-11926361.86461.93
3121411-12141162.97863.05
4123559-12355964.09264.16
5127311-12731166.03966.11
6126510-12651065.62365.70
15min1158247-15824782.08679.113.0182.2779.293.01
2146987-14698776.24576.42
3148918-14891877.24777.42
4150873-15087378.26178.44
5152422-15242279.06479.24
6157638-15763881.77081.95
20min1174931-17493190.74086.962.9191.0687.272.91
2164621-16462185.39285.69
3167324-16732486.79487.10
4162496-16249684.29084.60
5164428-16442885.29285.60
6172044-17204489.24389.56
30min1187440-18744097.22993.953.9197.7094.403.90
2188751-18875197.90998.35
3183315-18331595.08995.54
4172012-17201289.22689.67
5173159-17315989.82190.27
6182028-18202894.42194.89
45min1194952-194952101.12596.524.17101.7697.134.15
2186236-18623696.60497.21
3193523-193523100.384100.99
4176788-17678891.70392.30
5177309-17730991.97492.58
6187622-18762297.32397.95
60min1197653-197653102.52697.584.45103.3398.364.44
2188346-18834697.69998.47
3196399-196399101.876102.65
4178096-17809692.38293.13
5178730-17873092.71193.47
6189525-18952598.31099.10
极限1201540-201540104.54398.465.21105.5299.395.19
2189245-18924598.16599.09
3200450-200450103.977104.92
4179066-17906692.88593.79
5178782-17878292.73893.65
6189750-18975098.42799.38
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