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%
1 10.811865451859071863821861001863381862540.14
2 10.761836861845451841160.33
单位质量响应值RSD%判断
17229.7917111.150.49数据可信
供试品溶液-BXK34K1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%
5min134274-3427417.95119.5612.2317.9519.5612.22
237333-3733319.55319.55
338201-3820120.00720.01
437322-3732219.54719.55
531709-3170916.60716.61
645234-4523423.69123.69
10min172900-7290038.18140.808.4538.2140.848.45
281470-8147042.66942.70
372003-7200337.71137.74
477787-7778740.74040.77
574042-7404238.77938.81
689250-8925046.74446.78
15min198961-9896151.83053.966.3051.9254.066.31
2108568-10856856.86256.97
395547-9554750.04250.14
4102182-10218253.51753.62
599988-9998852.36852.46
6112881-11288159.12159.24
20min1117915-11791561.75763.154.6061.9463.344.61
2125592-12559265.77865.98
3113266-11326659.32259.50
4120314-12031463.01463.20
5117971-11797161.78661.97
6128389-12838967.24367.46
30min1142492-14249274.62975.012.9074.9175.302.91
2146463-14646376.70977.02
3137271-13727171.89572.17
4144181-14418175.51475.81
5140204-14020473.43173.71
6148655-14865577.85778.18
45min1164711-16471186.26684.981.6586.6785.401.66
2163510-16351085.63786.07
3159524-15952483.55083.95
4162247-16224784.97685.40
5158604-15860483.06883.47
6164935-16493586.38386.84
60min1175148-17514891.73289.911.3992.2890.481.39
2171991-17199190.07990.66
3169541-16954188.79689.33
4172785-17278590.49591.06
5168506-16850688.25488.80
6172071-17207190.12190.72
极限1180335-18033594.44993.810.6595.1594.520.65
2179484-17948494.00394.73
3179028-17902893.76594.45
4179705-17970594.11994.83
5176962-17696292.68393.37
6179190-17919093.84994.60
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%
1 10.811843761840821833771841171829431837790.33
2 10.761828051824191826120.15
单位质量响应值RSD%判断
17000.8316971.380.13数据可信
供试品溶液-BXK34K1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%
5min138778-3877820.53019.3613.4220.5319.3613.42
241497-4149721.96921.97
342071-4207122.27322.27
433309-3330917.63417.63
530084-3008415.92715.93
633693-3369317.83817.84
10min174408-7440839.39339.875.4739.4339.905.48
279337-7933742.00342.04
381505-8150543.15043.19
472541-7254138.40538.43
571616-7161637.91537.94
672475-7247538.37038.40
15min198422-9842252.10753.033.6152.2153.133.61
2103289-10328954.68354.79
3106027-10602756.13356.24
498013-9801351.89051.98
597987-9798751.87651.97
697242-9724251.48251.58
20min1114916-11491660.83962.012.4361.0362.202.44
2120268-12026863.67263.87
3121274-12127464.20564.41
4115428-11542861.11061.29
5115689-11568961.24861.42
6115241-11524161.01161.19
30min1136950-13695072.50473.641.5572.7973.931.56
2140657-14065774.46774.77
3142268-14226875.32075.63
4137076-13707672.57172.85
5139796-13979674.01174.29
6137850-13785072.98173.26
45min1156081-15608182.63383.411.4583.0483.821.45
2160136-16013684.77985.21
3158916-15891684.13484.57
4154724-15472481.91482.32
5159611-15961184.50184.90
6155801-15580182.48482.89
60min1167147-16714788.49188.771.6189.0489.321.60
2169354-16935489.66090.23
3168343-16834389.12489.70
4164471-16447187.07487.61
5171609-17160990.85391.40
6165080-16508087.39787.94
极限1177654-17765494.05493.840.6094.7594.540.59
2177938-17793894.20494.92
3176650-17665093.52294.25
4175743-17574393.04293.73
5178687-17868794.60195.29
6176852-17685293.62994.32
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%
1 10.811831591838591832211836551836841835160.17
2 10.761835881829311832600.26
单位质量响应值RSD%判断
16976.5017031.600.23数据可信
供试品溶液-BXK3152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%
5min122645-2264511.97615.2816.3111.9815.2816.30
228767-2876715.21415.21
333898-3389817.92717.93
434852-3485218.43218.43
525941-2594113.71913.72
627263-2726314.41814.42
10min165684-6568434.73836.445.6034.7636.475.61
264034-6403433.86533.89
374081-7408139.17939.21
471933-7193338.04338.07
567392-6739235.64135.66
670313-7031337.18637.21
15min191703-9170348.49850.202.7948.5850.282.80
291970-9197048.64048.72
398091-9809151.87751.97
496802-9680251.19551.29
594509-9450949.98250.06
696407-9640750.98651.07
20min1110768-11076858.58159.832.8858.7460.002.89
2108023-10802357.12957.29
3116581-11658161.65561.84
4115870-11587061.27961.46
5113113-11311359.82159.99
6114444-11444460.52560.70
30min1134808-13480871.29572.801.7771.5573.071.78
2135245-13524571.52671.78
3140605-14060574.36174.65
4139894-13989473.98574.27
5138652-13865273.32873.59
6136724-13672472.30872.58
45min1156259-15625982.64083.831.1883.0184.221.19
2157455-15745583.27283.65
3159589-15958984.40184.81
4161056-16105685.17785.58
5159681-15968184.44984.84
6157020-15702083.04283.43
60min1167724-16772488.70389.841.0389.2290.371.04
2170310-17031090.07190.59
3171180-17118090.53191.08
4172270-17227091.10791.65
5169612-16961289.70290.23
6168174-16817488.94189.47
极限1178512-17851294.40894.110.7695.0794.790.75
2177930-17793094.10194.77
3176794-17679493.50094.20
4180139-18013995.26995.97
5177953-17795394.11394.79
6176365-17636593.27393.95
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%
1 10.811837211834941823941836281833531833180.30
2 10.761821101827791824440.26
单位质量响应值RSD%判断
16958.1916955.760.02数据可信
供试品溶液-BXK3152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%
5min129825-2982515.81716.4810.9415.8216.4810.94
229100-2910015.43315.43
335489-3548918.82118.82
428783-2878315.26515.26
535316-3531618.72918.73
627974-2797414.83514.84
10min171214-7121437.76739.627.8237.7939.657.82
271559-7155937.95037.98
377629-7762941.16941.20
479907-7990742.37742.40
581471-8147143.20743.24
666520-6652035.27835.30
15min199198-9919852.60854.475.6452.7054.565.65
2100875-10087553.49753.59
3102082-10208254.13754.24
4107875-10787557.20957.31
5110994-11099458.86358.97
695206-9520650.49150.57
20min1121532-12153264.45265.604.1364.6365.784.13
2124109-12410965.81966.00
3119756-11975663.51063.70
4128534-12853468.16568.36
5130670-13067069.29869.50
6117560-11756062.34662.51
30min1146631-14663177.76378.301.6878.0578.601.69
2147453-14745378.19978.49
3146156-14615677.51177.81
4149209-14920979.13079.44
5151712-15171280.45780.77
6144735-14473576.75777.03
45min1165300-16530087.66486.731.1988.0887.161.18
2163721-16372186.82687.24
3162640-16264086.25386.68
4160343-16034385.03585.47
5165669-16566987.85988.31
6163586-16358686.75587.15
60min1174620-17462092.60691.301.6593.1791.871.64
2175105-17510592.86493.43
3169610-16961089.94990.52
4168376-16837689.29589.87
5174035-17403592.29692.89
6171164-17116490.77391.32
极限1180870-18087095.92195.141.1496.6495.861.14
2181919-18191996.47797.19
3177434-17743494.09994.82
4177628-17762894.20294.93
5180910-18091095.94296.69
6177659-17765994.21894.91
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