盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.011978691981421983331985471983651982510.13
210.971974371977731976050.13
单位质量响应值RSD%判断
18006.4518013.220.03数据可信
供试品溶液-24091302批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159943-5994329.87731.1712.7029.8831.1712.70
267883-6788333.83533.83
362495-6249531.14931.15
452039-5203925.93825.94
558089-5808928.95328.95
674783-7478337.27437.27
10min1103909-10390951.79149.318.8851.8449.368.88
2104682-10468252.17652.23
3101952-10195250.81650.87
492046-9204645.87845.92
584376-8437642.05542.10
6106621-10662153.14353.20
15min1122889-12288961.25159.184.0961.3959.324.10
2120856-12085660.23860.38
3119533-11953359.57959.72
4112189-11218955.91856.04
5113383-11338356.51356.63
6123587-12358761.59961.75
20min1134541-13454167.05965.252.6767.3065.482.68
2131726-13172665.65665.90
3130792-13079265.19065.43
4124527-12452762.06862.28
5130490-13049065.04065.25
6133388-13338866.48466.74
30min1148744-14874474.13872.522.2774.4972.862.27
2144870-14487072.20772.56
3144451-14445171.99872.34
4139870-13987069.71570.03
5148633-14863374.08374.40
6146372-14637272.95673.32
45min1162148-16214880.81979.342.0981.2979.802.08
2158224-15822478.86379.34
3157901-15790178.70279.17
4154114-15411476.81577.25
5163419-16341981.45381.90
6159269-15926979.38479.87
60min1169914-16991484.69083.492.0585.3084.082.04
2166049-16604982.76383.37
3164988-16498882.23582.83
4163811-16381181.64882.21
5173037-17303786.24686.83
6167202-16720283.33883.96
极限1181611-18161190.52090.021.4191.2790.751.39
2179052-17905289.24489.99
3177979-17797988.71089.44
4179304-17930489.37090.07
5185079-18507992.24992.97
6180570-18057090.00190.76
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.011970531969771969491967191968721969140.07
210.971967531975791971660.30
单位质量响应值RSD%判断
17885.0117973.200.35数据可信
供试品溶液-24071601批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min181352-8135240.73137.8311.8840.7337.8311.88
263701-6370131.89331.89
367889-6788933.99033.99
484405-8440542.25942.26
571730-7173035.91335.91
684298-8429842.20642.21
10min1115108-11510857.63253.696.0457.7053.766.04
298655-9865549.39449.45
3104226-10422652.18352.24
4111866-11186656.00956.08
5102167-10216751.15251.21
6111417-11141755.78455.85
15min1132310-13231066.24461.984.6766.4162.134.67
2116209-11620958.18358.32
3121592-12159260.87861.02
4126343-12634363.25763.42
5119666-11966659.91460.06
6126622-12662263.39663.56
20min1142515-14251571.35467.573.4471.6367.823.45
2129459-12945964.81765.05
3132266-13226666.22266.47
4136477-13647768.33168.60
5132249-13224966.21466.46
6136759-13675968.47268.74
30min1154895-15489577.55274.362.4477.9574.732.46
2144750-14475072.47372.81
3146746-14674673.47273.83
4148481-14848174.34174.72
5146211-14621173.20473.56
6150036-15003675.11975.50
45min1168476-16847684.35280.562.3784.8781.052.37
2158149-15814979.18179.64
3159373-15937379.79480.27
4160234-16023480.22580.73
5158907-15890779.56180.04
6160238-16023880.22780.74
60min1175936-17593688.08785.091.7788.7585.721.78
2168482-16848284.35584.95
3169186-16918684.70785.32
4167682-16768283.95484.59
5169510-16951084.86985.48
6168925-16892584.57785.22
极限1186388-18638893.32091.261.2194.1392.031.22
2182578-18257891.41292.15
3181475-18147590.86091.61
4179904-17990490.07390.85
5181955-18195591.10091.85
6181330-18133090.78791.57
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