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%
111.111994101993781990071987841984901990140.20
211.132015782019212017500.13
单位质量响应值RSD%判断
17913.0518126.680.84数据可信
供试品溶液-24050901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%
5min1122344-12234460.94864.457.2360.9564.457.23
2133179-13317966.34566.35
3146489-14648972.97672.98
4121636-12163660.59560.60
5127223-12722363.37863.38
6125389-12538962.46562.46
10min1148900-14890074.17777.184.8674.2877.284.86
2158031-15803178.72678.84
3167629-16762983.50783.63
4146339-14633972.90173.00
5153665-15366576.55176.66
6154963-15496377.19877.30
15min1159489-15948979.45281.883.6379.6882.113.64
2167503-16750383.44583.69
3173938-17393886.65086.91
4157124-15712478.27478.50
5163884-16388481.64281.87
6164206-16420681.80282.03
20min1165576-16557682.48584.583.0882.8484.953.09
2173187-17318786.27686.66
3177443-17744388.39688.80
4162924-16292481.16381.52
5169003-16900384.19284.56
6170510-17051084.94385.31
30min1172418-17241885.89387.932.6786.3988.442.67
2181410-18141090.37390.90
3181482-18148290.40890.96
4169882-16988284.63085.12
5176424-17642487.88988.40
6177415-17741588.38288.89
45min1178516-17851688.93190.702.1089.5791.362.11
2186993-18699393.15493.83
3185437-18543792.37993.08
4177163-17716388.25788.89
5181638-18163890.48691.14
6182678-18267891.00491.66
60min1181187-18118790.26291.841.6091.0592.651.61
2188546-18854693.92894.76
3186206-18620692.76293.62
4180908-18090890.12390.90
5184460-18446091.89292.70
6184764-18476492.04392.85
极限1186037-18603792.67892.732.0193.6193.691.98
2191342-19134295.32096.31
3180142-18014289.74190.75
4184464-18446491.89492.82
5187751-18775193.53194.49
6187081-18708193.19894.16
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%
111.112024532020402013612013022020642018440.25
211.132045852049182047520.12
单位质量响应值RSD%判断
18167.7818396.410.89数据可信
供试品溶液-24041201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%
5min195704-9570446.99358.339.8846.9958.339.88
2122748-12274860.27260.27
3123007-12300760.39960.40
4118337-11833758.10658.11
5125451-12545161.59961.60
6127541-12754162.62662.63
10min1141299-14129969.38172.062.6269.4672.152.63
2144473-14447370.94071.04
3148048-14804872.69572.80
4145318-14531871.35571.45
5149204-14920473.26373.37
6152124-15212474.69774.80
15min1155367-15536776.28977.721.6976.4877.941.70
2159105-15910578.12478.34
3156494-15649476.84277.06
4156583-15658376.88677.10
5159534-15953478.33578.56
6162631-16263179.85680.08
20min1163706-16370680.38480.742.0180.7081.092.01
2159705-15970578.41978.77
3165620-16562081.32381.67
4162220-16222079.65480.00
5166190-16619081.60381.96
6169156-16915683.06083.42
30min1172193-17219384.55185.170.9085.0185.650.91
2175876-17587686.35986.84
3173303-17330385.09685.58
4171866-17186684.39084.87
5172711-17271184.80585.30
6174718-17471885.79186.29
45min1180301-18030188.53288.220.3789.1388.840.35
2180228-18022888.49689.12
3180135-18013588.45189.08
4179434-17943488.10688.72
5178773-17877387.78288.41
6179111-17911187.94888.59
60min1183197-18319789.95490.210.8290.7090.980.82
2186414-18641491.53492.30
3181987-18198789.36090.13
4183667-18366790.18590.95
5182943-18294389.82990.61
6184137-18413790.41691.21
极限1189569-18956993.08391.442.2293.9892.362.19
2189904-18990493.24794.17
3186026-18602691.34392.27
4187437-18743792.03692.95
5178577-17857787.68688.61
6185881-18588191.27292.21
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