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 11.151987131987351993271984621981951986860.22
2 11.181992361981681987020.39
单位质量响应值RSD%判断
17819.3717772.990.19数据可信
供试品溶液-24122701批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1120861-12086160.96463.162.4260.9663.162.42
2126741-12674163.93063.93
3129150-12915065.14565.14
4126286-12628663.70063.70
5122476-12247661.77861.78
6125765-12576563.43763.44
10min1160664-16066481.04183.112.4081.1483.222.40
2161227-16122781.32581.43
3167399-16739984.43884.55
4165129-16512983.29383.40
5163183-16318382.31282.41
6170996-17099686.25386.36
15min1178183-17818389.87891.381.3790.1191.631.37
2178600-17860090.08890.33
3183525-18352592.57292.82
4183321-18332192.46992.71
5180225-18022590.90891.15
6183160-18316092.38892.64
20min1187469-18746994.56295.931.1494.9596.331.15
2187728-18772894.69295.08
3191414-19141496.55296.96
4191964-19196496.82997.23
5190055-19005595.86696.26
6192490-19249097.09497.50
30min1195085-19508598.40399.651.0398.95100.211.03
2195755-19575598.74199.29
3197613-19761399.678100.24
4199892-199892100.828101.39
5197149-19714999.444100.00
6199905-199905100.835101.40
45min1197984-19798499.866101.401.18100.57102.121.18
2199152-199152100.455101.17
3201360-201360101.568102.30
4203616-203616102.706103.43
5200253-200253101.010101.73
6203829-203829102.814103.55
60min1199066-199066100.411101.931.23101.29102.821.23
2200342-200342101.055101.94
3201318-201318101.547102.45
4205380-205380103.596104.50
5201651-201651101.715102.60
6204712-204712103.259104.16
极限1200084-200084100.925102.031.02101.97103.101.03
2200849-200849101.311102.36
3201207-201207101.491102.56
4205374-205374103.593104.67
5202013-202013101.898102.95
6204180-204180102.991104.07
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 11.151990961990121983561993761994111990500.22
2 11.181978611987051982830.31
单位质量响应值RSD%判断
17852.0217735.510.47数据可信
供试品溶液-24122701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%
5min1120727-12072760.90561.444.6860.9161.454.68
2114564-11456457.79657.80
3123128-12312862.11662.12
4116626-11662658.83658.84
5126036-12603663.58363.58
6129687-12968765.42565.43
10min1152257-15225776.81177.042.6276.9177.142.63
2148777-14877775.05675.15
3152468-15246876.91877.02
4148198-14819874.76474.86
5156208-15620878.80578.91
6158330-15833079.87579.98
15min1170094-17009485.81085.361.5886.0485.591.58
2166402-16640283.94784.17
3167517-16751784.51084.74
4166819-16681984.15884.38
5171641-17164186.59086.83
6172715-17271587.13287.37
20min1179591-17959190.60190.091.1890.9790.461.19
2177421-17742189.50689.87
3176501-17650189.04289.41
4176308-17630888.94589.31
5181060-18106091.34291.72
6180620-18062091.12091.51
30min1189428-18942895.56495.230.7696.0995.760.76
2189274-18927495.48696.00
3186521-18652194.09794.62
4187521-18752194.60295.11
5189623-18962395.66296.20
6190243-19024395.97596.51
45min1196096-19609698.92898.410.8899.6199.090.88
2196579-19657999.17199.84
3192258-19225896.99197.67
4193785-19378597.76298.43
5195245-19524598.49899.19
6196402-19640299.08299.78
60min1197947-19794799.86199.710.74100.71100.560.73
2199434-199434100.612101.45
3195557-19555798.65699.50
4196371-19637199.06699.90
5198710-198710100.246101.10
6197853-19785399.814100.68
极限1203927-203927102.878100.891.23103.89101.901.22
2201483-201483101.645102.65
3197411-19741199.591100.59
4198331-198331100.055101.05
5200396-200396101.097102.12
6198345-198345100.062101.09
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 11.151983542001851990281980761987141988710.42
2 11.181990841988691989760.08
单位质量响应值RSD%判断
17835.9617797.500.16数据可信
供试品溶液-24122701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%
5min1104298-10429852.54948.426.1052.5548.426.11
294345-9434547.53447.53
388185-8818544.43044.43
497178-9717848.96148.96
5100660-10066050.71650.72
691994-9199446.34946.35
10min1137823-13782369.43964.125.0769.5364.205.07
2124688-12468862.82262.90
3120764-12076460.84560.92
4126411-12641163.69063.77
5131760-13176066.38566.47
6122107-12210761.52161.60
15min1151080-15108076.11973.242.6276.3273.422.63
2141910-14191071.49971.68
3142148-14214871.61871.79
4146540-14654073.83174.02
5148073-14807374.60474.80
6142435-14243571.76371.94
20min1163085-16308582.16778.932.6282.5079.242.63
2153807-15380777.49377.80
3153216-15321677.19577.49
4158481-15848179.84880.16
5158665-15866579.94080.26
6152755-15275576.96377.26
30min1173876-17387687.60485.921.6188.0786.361.61
2166392-16639283.83384.27
3170265-17026585.78586.21
4172207-17220786.76387.21
5171964-17196486.64187.09
6168492-16849284.89185.32
45min1184154-18415492.78291.131.3493.4091.721.35
2178371-17837189.86990.44
3180441-18044190.91291.48
4183099-18309992.25192.84
5180968-18096891.17791.77
6178235-17823589.80090.37
60min1188727-18872795.08694.061.2495.8594.791.24
2183967-18396792.68893.41
3186797-18679794.11494.83
4189485-18948595.46896.21
5187053-18705394.24394.99
6184063-18406392.73793.46
极限1193643-19364397.56396.660.9998.4997.561.00
2189762-18976295.60896.48
3191851-19185196.66097.54
4194397-19439797.94398.84
5191601-19160196.53497.44
6189905-18990595.68096.55
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