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%
111.091897941895721902201902221896681898950.17
211.071896011893941894980.08
单位质量响应值RSD%判断
17123.0817118.160.03数据可信
供试品溶液-25070901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%
5min1121071-12107163.39063.270.9863.3963.260.98
2119168-11916862.39462.39
3122159-12215963.96063.96
4121954-12195463.85363.85
5119817-11981762.73462.73
6120844-12084463.27163.27
10min1160414-16041483.98982.481.2684.1082.581.26
2155446-15544681.38881.49
3157615-15761582.52482.63
4159206-15920683.35783.46
5155632-15563281.48681.59
6156839-15683982.11882.22
15min1176835-17683592.58791.381.5792.8391.621.56
2170590-17059089.31789.56
3175134-17513491.69791.94
4177983-17798393.18893.43
5172612-17261290.37690.62
6173973-17397391.08991.33
20min1185063-18506396.89595.681.3497.3096.071.33
2179834-17983494.15794.55
3184014-18401496.34696.74
4185367-18536797.05497.45
5180186-18018694.34294.73
6181933-18193395.25695.65
30min1192013-192013100.53499.511.62101.10100.071.62
2186874-18687497.84398.39
3189305-18930599.11699.67
4195227-195227102.217102.78
5187738-18773898.29698.84
6189227-18922799.07599.63
极限1194823-194823102.005100.761.23102.73101.481.23
2189784-18978499.367100.08
3192253-192253100.660101.38
4195695-195695102.462103.19
5190488-19048899.736100.45
6191665-191665100.352101.07
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%
111.091889321892001893261895461890621892130.13
211.071888181886701887440.06
单位质量响应值RSD%判断
17061.5917050.050.05数据可信
供试品溶液-3128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%
5min1124660-12466065.51765.033.1165.5265.033.11
2122321-12232164.28864.29
3124095-12409565.22065.22
4130655-13065568.66868.67
5120410-12041063.28463.28
6120261-12026163.20563.21
10min1158592-15859283.35183.682.4583.4683.792.45
2161384-16138484.81884.93
3159251-15925183.69783.81
4165509-16550986.98687.10
5155548-15554881.75181.86
6155019-15501981.47381.58
15min1171898-17189890.34491.242.6990.5991.492.69
2174816-17481691.87892.13
3177205-17720593.13393.38
4180243-18024394.73094.99
5169057-16905788.85189.09
6168442-16844288.52888.77
20min1176700-17670092.86893.772.7593.2794.182.75
2180760-18076095.00295.40
3179354-17935494.26394.67
4186444-18644497.98998.41
5174362-17436291.63992.03
6172931-17293190.88791.28
30min1179693-17969394.44195.272.8294.9995.822.82
2184943-18494397.20097.76
3181957-18195795.63196.19
4188955-18895599.30999.89
5175999-17599992.50093.04
6176050-17605092.52693.07
极限1179028-17902894.09196.013.0194.8096.723.01
2186875-18687598.21698.94
3184024-18402496.71797.44
4190845-190845100.302101.05
5178300-17830093.70994.41
6176975-17697593.01293.71
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