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%
111.151969141968071966791967541968871968080.05
211.101992831988041990440.18
单位质量响应值RSD%判断
17650.9417931.891.12数据可信
供试品溶液-T0704607DD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%
5min146891-4689123.71921.1528.6023.7221.1528.60
249983-4998325.28425.28
347642-4764224.09924.10
444047-4404722.28122.28
517807-178079.0089.01
644493-4449322.50622.51
10min1128673-12867365.08857.2412.0765.1357.2712.08
2123589-12358962.51762.56
3110011-11001155.64855.69
4115443-11544358.39658.43
589379-8937945.21245.23
6111793-11179356.55056.59
15min1172142-17214287.07784.003.2187.2284.143.23
2170743-17074386.36986.52
3163340-16334082.62482.76
4167712-16771284.83684.97
5157609-15760979.72579.82
6164848-16484883.38783.52
20min1180117-18011791.11189.791.6891.4090.061.70
2180748-18074891.43091.72
3175296-17529688.67288.94
4178202-17820290.14290.42
5172877-17287787.44987.67
6177850-17785089.96490.23
30min1187634-18763494.91394.051.0495.3694.471.06
2188363-18836395.28295.72
3183920-18392093.03593.45
4186179-18617994.17794.60
5183570-18357092.85893.23
6185901-18590194.03794.46
45min1189318-18931895.76595.680.5296.3796.260.53
2190404-19040496.31596.92
3187752-18775294.97395.55
4189647-18964795.93296.51
5188274-18827495.23795.76
6189468-18946895.84196.42
60min1190186-19018696.20495.740.6696.9796.470.66
2190434-19043496.33097.09
3188357-18835795.27996.01
4187218-18721894.70395.45
5189395-18939595.80496.49
6189963-18996396.09196.83
90min1189716-18971695.96695.780.6496.8996.680.66
2190610-19061096.41997.34
3188076-18807695.13796.03
4189564-18956495.89096.79
5187680-18768094.93795.78
6190412-19041296.31997.22
120min1188842-18884295.52495.820.6496.6196.870.64
2190263-19026396.24397.33
3187387-18738794.78895.84
4189948-18994896.08497.14
5189328-18932895.77096.77
6190739-19073996.48497.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1188846-18884695.52695.550.5596.7796.770.56
2190211-19021196.21797.46
3187561-18756194.87696.08
4188582-18858295.39396.61
5188199-18819995.19996.36
6190002-19000296.11197.33
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%
111.151984761984291981171982351977101981930.16
211.102011682010702011190.04
单位质量响应值RSD%判断
17775.1618118.831.36数据可信
供试品溶液-T0704607DD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%
5min18374-83744.1999.6745.884.209.6745.89
223289-2328911.67911.68
320781-2078110.42110.42
48343-83434.1844.18
528038-2803814.06014.06
626877-2687713.47813.48
10min135766-3576617.93627.7232.8917.9427.7332.90
253146-5314626.65126.67
357165-5716528.66728.68
434490-3449017.29617.30
577788-7778839.00939.03
673287-7328736.75136.77
15min179037-7903739.63545.5112.2539.6745.5712.28
287397-8739743.82743.89
393811-9381147.04447.11
478207-7820739.21939.25
5103202-10320251.75351.84
6102876-10287651.58951.67
20min193155-9315546.71551.087.2146.8251.227.25
299242-9924249.76749.90
3104255-10425552.28152.42
494822-9482247.55147.65
5108435-10843554.37754.55
6111256-11125655.79255.96
30min1101210-10121050.75453.614.3750.9353.834.42
2105192-10519252.75152.97
3108106-10810654.21254.44
4102701-10270151.50251.68
5111639-11163955.98456.25
6112558-11255856.44556.71
45min1104706-10470652.50754.543.0552.7754.863.11
2107687-10768754.00254.31
3109955-10995555.13955.46
4105696-10569653.00453.27
5111381-11138155.85556.21
6113190-11319056.76257.12
60min1105600-10560052.95654.442.2853.3154.842.35
2107770-10777054.04454.44
3109717-10971755.02055.43
4106021-10602153.16753.52
5110572-11057255.44955.90
6111626-11162655.97756.43
90min1105230-10523052.77053.861.9253.2154.361.99
2107380-10738053.84854.34
3107192-10719253.75454.26
4105216-10521652.76353.21
5108987-10898754.65455.20
6110434-11043455.38055.92
120min1103748-10374852.02753.261.5052.5653.851.56
2105901-10590153.10653.68
3107058-10705853.68754.28
4105348-10534852.82953.36
5106898-10689853.60654.24
6108338-10833854.32954.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1103779-10377952.04253.041.4752.6653.711.53
2104942-10494252.62653.29
3105895-10589553.10353.79
4105142-10514252.72653.35
5106554-10655453.43454.16
6108294-10829454.30655.03
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%
111.152006652008542003212001912000772004220.17
211.102032942032512032720.02
单位质量响应值RSD%判断
17975.0718312.791.32数据可信
供试品溶液-T0704607DD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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1655-6550.3250.4919.460.320.4819.98
2851-8510.4220.42
31122-11220.5570.56
41149-11490.5700.57
51068-10680.5300.53
61031-10310.5110.51
15min11321-13210.6550.714.370.660.714.12
21433-14330.7110.71
31471-14710.7300.73
41483-14830.7360.74
51478-14780.7330.73
61406-14060.6970.70
20min11472-14720.7300.743.770.730.743.78
21469-14690.7290.73
31537-15370.7620.76
41509-15090.7490.75
51587-15870.7870.79
61428-14280.7080.71
30min11409-14090.6990.704.480.700.704.42
21372-13720.6810.68
31393-13930.6910.69
41466-14660.7270.73
51468-14680.7280.73
61301-13010.6450.65
45min11321-13210.6550.653.440.660.663.46
21302-13020.6460.65
31338-13380.6640.67
41364-13640.6770.68
51354-13540.6720.68
61239-12390.6150.62
60min11262-12620.6260.613.990.630.624.09
21237-12370.6140.62
31258-12580.6240.63
41273-12730.6310.64
51264-12640.6270.63
61142-11420.5660.57
90min11116-11160.5540.583.010.560.583.01
21154-11540.5720.58
31168-11680.5790.59
41144-11440.5670.57
51222-12220.6060.61
61167-11670.5790.59
120min11084-10840.5380.553.470.540.563.97
21114-11140.5530.56
31145-11450.5680.58
41153-11530.5720.58
51144-11440.5670.58
61057-10570.5240.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限11062-10620.5270.542.640.530.553.15
21076-10760.5340.54
31099-10990.5450.55
41088-10880.5400.55
51143-11430.5670.58
61072-10720.5320.54
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%
111.151996611996561998492000821995311997560.11
211.102031052025822028440.19
单位质量响应值RSD%判断
17915.3418274.231.41数据可信
供试品溶液-T0704607DD批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119366-193669.63216.4425.099.6316.4425.10
235630-3563017.72217.72
339990-3999019.89019.89
437150-3715018.47818.48
539617-3961719.70519.70
626585-2658513.22313.22
10min165685-6568532.67047.1918.1332.6947.2118.13
2101393-10139350.43150.46
3109492-10949254.45954.49
4102776-10277651.11951.15
5107341-10734153.38953.42
682531-8253141.04941.07
15min1119656-11965659.51574.6111.0259.5974.7211.03
2156932-15693278.05578.17
3161598-16159880.37680.50
4158847-15884779.00779.12
5161014-16101480.08580.21
6142044-14204470.65070.74
20min1163911-16391181.52686.253.4281.7086.483.45
2174376-17437686.73186.97
3179047-17904789.05489.31
4177109-17710988.09088.34
5177414-17741488.24288.50
6168651-16865183.88484.09
30min1185652-18565292.34093.571.4192.6593.941.43
2186739-18673992.88093.27
3191274-19127495.13695.54
4189995-18999594.50094.89
5190048-19004894.52694.93
6185005-18500592.01892.37
45min1194670-19467096.82596.861.0097.2897.381.02
2192895-19289595.94296.49
3197182-19718298.07498.64
4195969-19596997.47198.02
5195634-19563497.30497.86
6192047-19204795.52096.02
60min1196980-19698097.97497.750.8398.5998.440.85
2194636-19463696.80897.51
3198759-19875998.85999.59
4197243-19724398.10598.82
5197004-19700497.98698.71
6194588-19458896.78497.44
90min1197818-19781898.39197.511.0699.1798.371.06
2193764-19376496.37497.24
3198170-19817098.56699.46
4197239-19723998.10398.98
5195980-19598097.47798.36
6193365-19336596.17697.00
120min1197146-19714698.05697.581.0899.0098.601.08
2194137-19413796.56097.58
3198990-19899098.974100.03
4197225-19722598.09699.14
5196329-19632997.65098.70
6193354-19335496.17097.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1196916-19691697.94297.350.9999.0598.520.99
2193993-19399396.48897.67
3197374-19737498.17099.39
4197292-19729298.12999.33
5195984-19598497.47998.69
6192744-19274495.86797.01
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