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(%)99.99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%
111.141994741996691993651994451990691994040.11
211.112016562015402015980.05
单位质量响应值RSD%判断
17899.8218145.630.97数据可信
供试品溶液-24041501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%
5min1106822-10682253.34158.656.3353.3458.666.33
2128420-12842064.12664.13
3116525-11652558.18658.19
4116272-11627258.06058.06
5122743-12274361.29161.29
6113984-11398456.91756.92
10min1142392-14239271.10273.692.1771.1973.792.18
2151852-15185275.82675.93
3147839-14783973.82273.92
4148142-14814273.97474.07
5149304-14930474.55474.66
6145933-14593372.87172.97
15min1158442-15844279.11781.001.8179.3281.211.82
2166440-16644083.11183.34
3161800-16180080.79481.01
4162886-16288681.33681.56
5164069-16406981.92782.15
6159580-15958079.68579.90
20min1164674-16467482.22984.691.9382.5785.051.94
2174565-17456587.16887.54
3169606-16960684.69285.05
4170133-17013384.95585.31
5170769-17076985.27285.64
6167878-16787883.82984.18
30min1176146-17614687.95789.151.5488.4389.651.55
2183031-18303191.39591.91
3177982-17798288.87489.37
4179022-17902289.39389.89
5179689-17968989.72690.23
6175388-17538887.57988.07
45min1182359-18235991.06092.211.3191.6892.851.32
2188701-18870194.22694.90
3185500-18550092.62893.27
4184804-18480492.28192.93
5184536-18453692.14792.80
6182055-18205590.90891.54
60min1186010-18601092.88394.061.3893.6694.861.39
2192725-19272596.23697.06
3188806-18880694.27995.08
4188294-18829494.02394.82
5188966-18896694.35995.17
6185421-18542192.58993.37
极限1190417-19041795.08395.701.3096.0196.651.31
2196051-19605197.89798.88
3191475-19147595.61296.57
4192071-19207195.90996.87
5191310-19131095.52996.49
6188535-18853594.14495.08
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(%)99.99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%
111.142026922028552028392027492031972028660.10
211.112018992018482018740.02
单位质量响应值RSD%判断
18210.5918170.480.16数据可信
供试品溶液-24041502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%
5min1124592-12459261.63762.404.7661.6462.404.76
2134777-13477766.67666.68
3121009-12100959.86559.86
4120297-12029759.51359.51
5123849-12384961.27061.27
6132247-13224765.42465.42
10min1151144-15114474.77376.112.4774.8876.222.47
2158080-15808078.20478.32
3154953-15495376.65776.76
4153024-15302475.70375.80
5148297-14829773.36573.47
6157565-15756577.95078.06
15min1165510-16551081.88083.201.7882.1183.431.78
2170674-17067484.43584.68
3169871-16987184.03884.27
4167626-16762682.92783.15
5163960-16396081.11381.34
6171399-17139984.79385.03
20min1173849-17384986.00687.361.4286.3787.731.43
2178605-17860588.35888.74
3178286-17828688.20188.57
4176904-17690487.51787.88
5173121-17312185.64586.00
6178767-17876788.43988.82
30min1182338-18233890.20591.080.9790.7191.590.97
2185514-18551491.77692.31
3185009-18500991.52792.04
4183955-18395591.00591.51
5181687-18168789.88390.39
6186102-18610292.06792.59
45min1186387-18638792.20893.200.7792.8793.870.78
2189905-18990593.94994.63
3188983-18898393.49394.16
4188235-18823593.12293.78
5187065-18706592.54493.20
6189812-18981293.90394.58
60min1189158-18915893.57994.180.7094.3995.010.71
2191851-19185194.91195.75
3190579-19057994.28295.11
4190756-19075694.37095.19
5188454-18845493.23194.04
6191495-19149594.73595.57
极限1190923-19092394.45294.830.6795.4295.820.68
2193008-19300895.48496.48
3191798-19179894.88595.87
4192040-19204095.00595.98
5189602-18960293.79994.76
6192802-19280295.38296.38
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