盐酸鲁拉西酮片项目信息
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%
111.241986091988861984331985741984171985840.10
211.251999001999701999350.03
单位质量响应值RSD%判断
17667.6217772.000.42数据可信
供试品溶液-24071601批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1110953-11095356.20852.8916.8656.2152.9016.86
2114807-11480758.16058.16
3112626-11262657.05557.06
4110514-11051455.98555.99
5108850-10885055.14255.14
668731-6873134.81834.82
10min1143297-14329772.59371.525.9872.6971.615.99
2143863-14386372.88072.98
3147214-14721474.57774.67
4144746-14474673.32773.42
5143774-14377472.83472.93
6124201-12420162.91962.98
15min1158804-15880480.44979.484.8080.6679.694.81
2157899-15789979.99080.21
3162778-16277882.46282.68
4160897-16089781.50981.72
5159009-15900980.55280.77
6141962-14196271.91772.08
20min1167924-16792485.06984.812.5485.4285.152.56
2167350-16735084.77885.13
3171356-17135686.80787.16
4169915-16991586.07786.43
5168656-16865685.43985.79
6159256-15925680.67880.96
30min1178557-17855790.45590.001.8990.9590.481.91
2177114-17711489.72490.22
3176329-17632989.32789.83
4181465-18146591.92892.42
5180383-18038391.38091.87
6172067-17206787.16787.58
45min1186619-18661994.53994.881.5495.1895.511.56
2185704-18570494.07694.72
3190551-19055196.53197.18
4188786-18878695.63796.29
5189377-18937795.93696.58
6182700-18270092.55493.12
60min1191786-19178697.15797.491.3197.9698.281.33
2190233-19023396.37097.17
3195969-19596999.276100.09
4193229-19322997.88898.70
5194207-19420798.38399.19
6189272-18927295.88396.60
极限1196656-19665699.624100.440.77100.58101.390.77
2196545-19654599.568100.53
3199988-199988101.312102.29
4198556-198556100.586101.56
5199919-199919101.277102.24
6197892-197892100.250101.13
盐酸鲁拉西酮片项目信息
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%
111.241983281981641983391983071982641982800.04
211.252006962008962007960.08
单位质量响应值RSD%判断
17640.5717848.530.83数据可信
供试品溶液-24071601批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179787-7978740.36450.1810.2340.3650.1810.23
298865-9886550.01550.02
399038-9903850.10350.10
4104056-10405652.64252.64
5107497-10749754.38254.38
6105911-10591153.58053.58
10min1137151-13715169.38472.763.6069.4572.843.60
2140177-14017770.91571.00
3140524-14052471.09171.17
4147238-14723874.48774.57
5149651-14965175.70875.80
6148200-14820074.97475.06
15min1162016-16201681.96383.342.6482.1583.542.65
2159812-15981280.84881.05
3160702-16070281.29981.50
4167925-16792584.95385.16
5169265-16926585.63185.85
6168700-16870085.34585.56
20min1175279-17527988.67388.982.3688.9989.332.36
2170179-17017986.09386.43
3171830-17183086.92887.27
4179182-17918290.64891.00
5179749-17974990.93491.29
6179145-17914590.62990.99
30min1188025-18802595.12194.862.0295.5995.362.02
2181670-18167091.90692.39
3184140-18414093.15693.64
4190291-19029196.26896.77
5190144-19014496.19396.70
6190808-19080896.52997.04
45min1195059-19505998.68098.161.5499.3198.811.55
2189249-18924995.74096.37
3191522-19152296.89097.53
4197015-19701599.669100.33
5195455-19545598.88099.55
6195888-19588899.09999.77
60min1197847-197847100.09099.541.48100.88100.351.48
2192169-19216997.21898.01
3194219-19421998.25599.05
4199636-199636100.995101.83
5198321-198321100.330101.17
6198334-198334100.336101.17
极限1201152-201152101.762100.681.03102.72101.661.04
2196531-19653199.424100.38
3196362-19636299.339100.30
4199754-199754101.055102.05
5200037-200037101.198102.20
6200296-200296101.329102.33
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