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%
110.931935891935221934071932971930881933810.11
211.051962021960361961190.06
单位质量响应值RSD%判断
17692.6817748.330.23数据可信
加速2月-供试品溶液-24041201-bz1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%
5min185283-8528343.20242.436.5243.2042.426.53
273696-7369637.33237.33
389807-8980745.49345.49
483348-8334842.22142.22
586714-8671443.92643.93
683657-8365742.37842.38
10min1139482-13948270.65766.734.0870.7366.804.08
2134324-13432468.04468.11
3132391-13239167.06567.14
4127756-12775664.71764.79
5123946-12394662.78762.86
6132516-13251667.12867.20
15min1156137-15613779.09476.452.6179.2876.632.61
2154510-15451078.27078.45
3149023-14902375.49075.68
4152024-15202477.01077.19
5146967-14696774.44974.63
6146797-14679774.36374.55
20min1160528-16052881.31877.943.6681.6478.253.65
2159858-15985880.97981.28
3153624-15362477.82178.13
4145555-14555573.73374.04
5151758-15175876.87677.18
6151871-15187176.93377.24
30min1167822-16782285.01381.972.9585.4782.412.94
2167693-16769384.94885.39
3160447-16044781.27781.72
4157064-15706479.56379.99
5159813-15981380.95681.39
6158020-15802080.04880.48
45min1173598-17359887.93985.732.5088.5486.302.49
2175316-17531688.80989.39
3168072-16807285.14085.72
4165378-16537883.77584.34
5167494-16749484.84785.41
6165550-16555083.86284.43
60min1178652-17865290.49988.671.9891.2489.391.98
2179469-17946990.91391.64
3174025-17402588.15588.88
4174247-17424788.26888.97
5173627-17362787.95488.66
6170207-17020786.22186.93
极限1185280-18528093.85793.042.3694.7593.902.34
2185866-18586694.15495.04
3180175-18017591.27192.14
4188957-18895795.71996.57
5184692-18469293.55994.41
6176983-17698389.65490.51
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%
110.931929831926861924081927471927351927120.11
211.051985761982611984180.12
单位质量响应值RSD%判断
17631.4717956.381.30数据可信
加速2月-供试品溶液-24041201-bz2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%
5min186408-8640843.59447.577.7643.5947.567.76
293035-9303546.93846.94
391346-9134646.08646.09
491558-9155846.19346.19
595402-9540248.13248.13
6107928-10792854.45254.45
10min1140871-14087171.07272.381.6071.1472.461.60
2144820-14482073.06473.14
3140821-14082171.04771.12
4146097-14609773.70973.79
5142907-14290772.09972.18
6145272-14527273.29273.38
15min1152121-15212176.74878.571.8876.9478.771.88
2159218-15921880.32880.53
3153501-15350177.44477.64
4158514-15851479.97380.17
5153984-15398477.68877.89
6157046-15704679.23279.45
20min1161858-16185881.66081.240.6581.9881.560.65
2162514-16251481.99182.33
3160092-16009280.76981.09
4160688-16068881.07081.40
5161151-16115181.30481.63
6159795-15979580.61980.96
30min1166565-16656584.03584.500.7084.4984.970.70
2168280-16828084.90085.37
3167831-16783184.67485.13
4168531-16853185.02785.50
5168188-16818884.85485.32
6165579-16557983.53884.02
45min1174139-17413987.85687.781.1888.4588.391.17
2175958-17595888.77489.39
3173788-17378887.67988.28
4174048-17404887.81088.42
5175743-17574388.66589.27
6170250-17025085.89486.51
60min1179339-17933990.48089.881.2591.2290.641.24
2180354-18035490.99291.75
3178298-17829889.95490.70
4176938-17693889.26890.02
5179667-17966790.64591.40
6174338-17433887.95788.72
极限1184986-18498693.32992.751.1194.2293.651.10
2186210-18621093.94694.86
3181545-18154591.59392.49
4183631-18363192.64593.55
5185288-18528893.48194.39
6181317-18131791.47892.39
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