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%
111.181941951939661935881945301941991940960.18
211.221945601948901947250.12
单位质量响应值RSD%判断
17361.0017355.170.03数据可信
供试品溶液-25010302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%
5min1-0.0000.41155.720.000.41155.68
22597-25971.3431.34
3-0.0000.00
4-0.0000.00
5-0.0000.00
62201-22011.1381.14
10min11527-15270.7900.7752.650.790.7752.60
21620-16200.8380.84
32170-21701.1221.12
42114-21141.0931.09
5-0.0000.00
61530-15300.7910.79
15min11329-13290.6871.0542.580.691.0542.38
21470-14700.7600.76
31674-16740.8660.87
43010-30101.5571.56
53254-32541.6831.68
61444-14440.7470.75
20min11227-12270.6350.707.110.640.716.89
21329-13290.6870.69
31523-15230.7880.79
41360-13600.7030.71
51395-13950.7210.72
61340-13400.6930.70
30min11236-12360.6390.656.110.640.666.41
21193-11930.6170.62
31414-14140.7310.74
41262-12620.6530.66
51258-12580.6510.65
61225-12250.6330.64
45min11098-10980.5680.596.470.570.606.27
21060-10600.5480.56
31268-12680.6560.66
41097-10970.5670.57
51163-11630.6010.61
61141-11410.5900.60
60min11052-10520.5440.7358.630.550.7458.53
23089-30891.5971.61
31185-11850.6130.62
4979-9790.5060.51
51088-10880.5630.57
61057-10570.5470.55
极限1932-9320.4820.8592.030.490.8691.31
21007-10070.5210.53
31182-11820.6110.62
4955-9550.4940.50
51076-10760.5560.56
64740-47402.4512.46
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%
111.181953821957361953921951141950361953320.15
211.221942101956461949280.53
单位质量响应值RSD%判断
17471.5617373.260.40数据可信
供试品溶液-25010302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%
5min11939-19390.9990.63113.271.000.63113.31
23040-30401.5661.57
3-0.0000.00
4-0.0000.00
5-0.0000.00
62353-23531.2121.21
10min11540-15400.7930.7853.990.800.7853.83
21618-16180.8340.84
3-0.0000.00
42022-20221.0421.04
52373-23731.2231.22
61478-14780.7620.76
15min11804-18040.9291.43108.770.931.43108.44
21361-13610.7010.71
31455-14550.7500.75
41695-16950.8730.88
58903-89034.5874.59
61391-13910.7170.72
20min11339-13390.6900.729.170.690.739.69
21251-12510.6450.65
31356-13560.6990.70
41479-14790.7620.77
51623-16230.8360.85
61392-13920.7170.72
30min11187-11870.6120.668.360.620.668.35
21151-11510.5930.60
31244-12440.6410.64
41401-14010.7220.73
51405-14050.7240.73
61271-12710.6550.66
45min11106-11060.5700.618.990.580.629.10
21042-10420.5370.54
31165-11650.6000.60
41325-13250.6830.69
51284-12840.6620.67
61187-11870.6120.62
60min11041-10410.5360.576.820.540.587.00
21027-10270.5290.54
31101-11010.5670.57
41180-11800.6080.61
51212-12120.6240.64
61072-10720.5520.56
极限11575-15750.8110.6118.110.820.6118.09
21016-10160.5230.53
31063-10630.5480.55
41079-10790.5560.56
51260-12600.6490.66
61061-10610.5470.56
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