非奈利酮片项目信息
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.061941451939391941311939711938061939980.08
210.981948281948981948630.03
单位质量响应值RSD%判断
17540.5117747.090.83数据可信
供试品溶液-BXK0L71批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148703-4870324.84427.338.8024.8427.338.81
257650-5765029.40829.41
350171-5017125.59325.59
454565-5456527.83427.83
560344-6034430.78230.78
650050-5005025.53125.53
10min1123207-12320762.84961.204.6462.8961.244.64
2116912-11691259.63859.69
3118448-11844860.42260.46
4112412-11241257.34357.39
5128665-12866565.63465.68
6120140-12014061.28561.33
15min1153696-15369678.40276.002.8578.5576.152.85
2145245-14524574.09174.24
3147830-14783075.41075.55
4143153-14315373.02473.17
5151573-15157377.31977.48
6152435-15243577.75977.90
20min1162064-16206482.67182.191.6482.9582.461.64
2160276-16027681.75982.03
3161180-16118082.22082.49
4156901-15690180.03780.30
5161284-16128482.27382.56
6165008-16500884.17384.45
30min1172949-17294988.22387.890.8988.6488.300.89
2171580-17158087.52587.93
3173087-17308788.29488.70
4170381-17038186.91387.31
5171213-17121387.33887.76
6174572-17457289.05189.47
45min1177435-17743590.51290.140.4191.0790.700.40
2176708-17670890.14190.69
3176928-17692890.25390.81
4176291-17629189.92890.47
5175546-17554689.54890.12
6177357-17735790.47291.03
60min1178014-17801490.80790.730.6191.5291.440.61
2177684-17768490.63991.34
3177658-17765890.62591.33
4177255-17725590.42091.11
5176726-17672690.15090.87
6179876-17987691.75792.47
极限1186530-18653095.15195.760.7896.0196.620.76
2189492-18949296.66297.52
3186973-18697395.37796.23
4189609-18960996.72297.56
5187297-18729795.54296.41
6186445-18644595.10895.97
非奈利酮片项目信息
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.061956171957061956931957131958571957170.05
210.981948291950191949240.07
单位质量响应值RSD%判断
17695.9317752.640.23数据可信
供试品溶液-BXK0L71批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min131380-3138015.93424.1016.7415.9324.1016.75
250564-5056425.67525.68
351180-5118025.98825.99
449624-4962425.19825.20
552300-5230026.55726.56
649747-4974725.26025.26
10min163095-6309532.03843.6713.7532.0643.7113.75
292736-9273647.08947.13
394927-9492748.20248.25
489007-8900745.19645.24
592031-9203146.73146.78
684236-8423642.77342.82
15min194521-9452147.99656.378.3548.0856.488.36
2116751-11675159.28459.40
3118804-11880460.32660.45
4114004-11400457.88958.01
5116203-11620359.00559.13
6105764-10576453.70553.82
20min1116472-11647259.14265.355.6159.3065.565.63
2133868-13386867.97568.20
3135036-13503668.56868.79
4131713-13171366.88167.09
5131601-13160166.82467.04
6123540-12354062.73162.93
30min1143561-14356172.89776.593.2773.1676.903.29
2155011-15501178.71179.04
3156090-15609079.25979.60
4152846-15284677.61277.94
5150999-15099976.67477.01
6146440-14644074.35974.67
45min1163541-16354183.04385.512.5283.4285.962.53
2172806-17280687.74788.21
3173276-17327687.98688.46
4170108-17010886.37786.83
5166090-16609084.33784.80
6164615-16461583.58884.02
60min1172365-17236587.52390.102.3788.0490.682.39
2181681-18168192.25492.86
3181347-18134792.08492.70
4180529-18052991.66992.27
5173887-17388788.29688.90
6174823-17482388.77189.34
极限1182819-18281992.83294.291.4293.5095.031.43
2189306-18930696.12696.89
3185742-18574294.31695.09
4188178-18817895.55396.30
5183131-18313192.99093.74
6185015-18501593.94794.67
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