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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.063821513797073788373785103791263796660.39
2 11.073798603797733798160.02
单位质量响应值RSD%判断
34327.8534310.390.04数据可信
供试品溶液-1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%
5min173001-7300119.12918.878.2019.1318.878.20
265902-6590217.26917.27
367202-6720217.60917.61
470378-7037818.44118.44
573185-7318519.17719.18
682432-8243221.60021.60
10min1133300-13330034.92934.614.5734.9634.644.57
2130460-13046034.18534.21
3127931-12793133.52233.55
4131051-13105134.34034.37
5126411-12641133.12433.16
6143351-14335137.56337.60
15min1165705-16570543.42043.362.9043.5143.442.90
2165261-16526143.30443.39
3163601-16360142.86942.95
4163804-16380442.92243.01
5160038-16003841.93642.02
6174337-17433745.68245.78
20min1186437-18643748.85349.101.8549.0249.261.86
2186691-18669148.92049.08
3186812-18681248.95149.11
4185937-18593748.72248.88
5184178-18417848.26148.42
6194143-19414350.87251.05
30min1213761-21376156.01356.371.3556.2656.611.36
2214327-21432756.16156.40
3216300-21630056.67856.92
4214480-21448056.20156.44
5211656-21165655.46155.70
6220193-22019357.69857.96
45min1238284-23828462.43962.940.9862.7863.270.99
2239472-23947262.75063.08
3241261-24126163.21963.55
4239702-23970262.81063.14
5238007-23800762.36662.70
6244360-24436064.03164.39
60min1253950-25395066.54466.970.6366.9967.410.64
2255093-25509366.84367.28
3256543-25654367.22367.66
4255050-25505066.83267.27
5254488-25448866.68567.12
6258344-25834467.69568.16
极限1265398-26539869.54369.890.3670.1070.450.36
2267979-26797970.22070.77
3266411-26641169.80970.36
4266127-26612769.73570.28
5267075-26707569.98370.53
6267442-26744270.07970.65
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.063792253775893764663766023765663772900.32
2 11.073764963769293767120.09
单位质量响应值RSD%判断
34113.0234029.990.18数据可信
供试品溶液-1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%
5min143917-4391711.5919.7819.7411.599.7819.75
232309-323098.5288.53
342197-4219711.13711.14
443272-4327211.42111.42
534881-348819.2069.21
625740-257406.7946.79
10min177095-7709520.34818.1711.6520.3718.1911.66
262016-6201616.36816.38
373786-7378619.47519.49
476130-7613020.09420.11
566390-6639017.52317.54
657740-5774015.24015.25
15min195986-9598625.33423.407.4625.3923.447.47
281646-8164621.55021.59
392412-9241224.39124.44
494711-9471124.99825.05
586126-8612622.73222.78
680999-8099921.37921.42
20min1108944-10894428.75527.085.4828.8527.175.50
296615-9661525.50125.58
3105786-10578627.92128.01
4107919-10791928.48428.58
599653-9965326.30226.38
696726-9672625.53025.60
30min1127094-12709433.54532.273.3633.6932.413.39
2118218-11821831.20231.32
3124583-12458332.88233.02
4126067-12606733.27433.42
5117951-11795131.13231.26
6119775-11977531.61331.73
45min1145131-14513138.30637.564.1538.5137.744.15
2138848-13884836.64736.82
3142599-14259937.63737.83
4152484-15248440.24740.44
5136818-13681836.11236.29
6137846-13784636.38336.55
60min1157750-15775041.63640.712.3341.9040.962.36
2152836-15283640.33940.57
3155110-15511040.94041.20
4158758-15875841.90242.17
5149826-14982639.54539.78
6151173-15117339.90140.13
极限1165664-16566443.72542.871.7844.0643.191.81
2162544-16254442.90243.20
3163784-16378443.22943.55
4164636-16463643.45443.79
5158370-15837041.80042.10
6159602-15960242.12542.42
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.063806663777093781043784433775613784970.34
2 11.073778603781153779880.05
单位质量响应值RSD%判断
34222.1534145.260.16数据可信
供试品溶液-2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%
5min181891-8189121.54320.5710.7921.5420.5710.78
275713-7571319.91819.92
377061-7706120.27320.27
463518-6351816.71016.71
588006-8800623.15223.15
682940-8294021.81921.82
10min1139011-13901136.57036.223.2736.6136.263.27
2133820-13382035.20435.24
3136827-13682735.99536.03
4132096-13209634.75134.78
5144610-14461038.04338.08
6139760-13976036.76736.80
15min1171247-17124745.05045.241.9645.1545.341.97
2168174-16817444.24244.33
3172158-17215845.29045.38
4168976-16897644.45344.54
5177329-17732946.65046.75
6173980-17398045.76945.87
20min1195517-19551751.43551.701.2251.6151.871.22
2197470-19747051.94952.11
3197870-19787052.05452.22
4192393-19239350.61350.77
5199267-19926752.42252.60
6196620-19662051.72551.90
30min1223972-22397258.92158.990.5959.1859.240.59
2223405-22340558.77259.02
3226050-22605059.46859.72
4222664-22266458.57758.82
5225560-22556059.33959.61
6223727-22372758.85759.12
45min1247537-24753765.12065.570.5965.4865.930.58
2248588-24858865.39765.75
3251537-25153766.17366.53
4249592-24959265.66166.00
5250088-25008865.79166.16
6248206-24820665.29665.65
60min1262379-26237969.02569.570.6069.4970.040.59
2263707-26370769.37469.83
3266486-26648670.10570.57
4265688-26568869.89570.35
5265193-26519369.76570.24
6263354-26335469.28169.75
极限1271627-27162771.45871.890.5272.0472.470.51
2271957-27195771.54572.12
3274836-27483672.30272.88
4274462-27446272.20472.77
5274241-27424172.14572.74
6272491-27249171.68572.27
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.063784353781453778063778113787713781940.11
2 11.073778253774183776220.08
单位质量响应值RSD%判断
34194.7634112.200.18数据可信
供试品溶液-t2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%
5min144498-4449811.71711.412.1711.7211.412.17
243649-4364911.49311.49
343989-4398911.58311.58
442804-4280411.27111.27
541855-4185511.02111.02
643141-4314111.35911.36
10min171150-7115018.73419.011.0918.7519.031.09
272414-7241419.06719.09
373238-7323819.28419.30
472650-7265019.12919.15
571396-7139618.79918.82
672270-7227019.02919.05
15min188765-8876523.37223.881.2323.4223.931.24
290627-9062723.86323.91
392191-9219124.27424.33
491079-9107923.98224.03
590555-9055523.84423.89
690891-9089123.93223.98
20min1101396-10139626.69827.571.6826.7927.661.67
2104481-10448127.51027.60
3106322-10632227.99528.09
4105214-10521427.70327.79
5104990-10499027.64427.73
6105864-10586427.87527.97
30min1121103-12110331.88732.711.6432.0232.851.64
2123534-12353432.52732.66
3127329-12732933.52633.67
4124478-12447832.77632.91
5124016-12401632.65432.79
6124998-12499832.91333.05
45min1140732-14073237.05637.641.3337.2437.831.34
2142210-14221037.44537.64
3146191-14619138.49338.69
4142428-14242837.50237.69
5142129-14212937.42337.61
6143991-14399137.91438.11
60min1151978-15197840.01740.901.6340.2741.151.62
2154088-15408840.57240.83
3159207-15920741.92042.18
4155184-15518440.86141.11
5154363-15436340.64540.90
6157068-15706841.35741.61
极限1160599-16059942.28743.212.1842.6043.532.17
2162122-16212242.68843.01
3170730-17073044.95445.28
4162909-16290942.89543.22
5163151-16315142.95943.28
6165126-16512643.47943.80
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