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%
110.961899181901171903791897621896601899670.16
210.951905621909941907780.17
单位质量响应值RSD%判断
17332.7617422.650.37数据可信
供试品溶液-2025011721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%
5min195212-9521249.18346.794.2149.1846.804.21
293439-9343948.26748.27
386913-8691344.89644.90
491083-9108347.05047.05
585281-8528144.05344.05
691601-9160147.31847.32
10min1129295-12929566.78966.002.2666.8766.082.26
2131188-13118867.76767.85
3125530-12553064.84464.92
4130398-13039867.35967.44
5124227-12422764.17164.24
6126026-12602665.10065.18
15min1148760-14876076.84476.401.5277.0476.581.52
2151019-15101978.01178.20
3146759-14675975.81075.99
4149571-14957177.26377.45
5145294-14529475.05375.23
6145991-14599175.41375.60
20min1160446-16044682.88082.831.4383.2083.141.44
2163790-16379084.60884.93
3159027-15902782.14782.46
4162286-16228683.83184.15
5158081-15808181.65981.96
6158406-15840681.82782.14
30min1173045-17304589.38889.141.0889.8589.601.08
2173799-17379989.77890.24
3171053-17105388.35988.81
4175241-17524190.52390.98
5172132-17213288.91789.36
6170124-17012487.88088.33
45min1180357-18035793.16693.041.1393.7793.641.13
2181338-18133893.67294.29
3178800-17880092.36192.95
4181751-18175193.88694.50
5181739-18173993.87994.47
6176640-17664091.24691.84
60min1184616-18461695.36694.571.1796.1395.321.16
2183257-18325794.66495.43
3181545-18154593.77994.53
4184844-18484495.48396.25
5184609-18460995.36296.11
6179560-17956092.75493.50
极限1187531-18753196.87197.331.0897.7998.241.07
2189215-18921597.74198.67
3189188-18918897.72798.63
4188900-18890097.57998.50
5190806-19080698.56399.47
6184872-18487295.49896.40
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%
110.961904371901651903701904841903841903680.07
210.951904961899531902240.21
单位质量响应值RSD%判断
17369.3417372.050.02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%
5min140906-4090621.13919.6331.7721.1419.6431.77
235387-3538718.28718.29
342162-4216221.78821.79
456728-5672829.31529.32
532512-3251216.80116.80
620254-2025410.46710.47
10min1108789-10878956.21960.7120.6056.2560.7420.61
2112142-11214257.95157.98
3140705-14070572.71272.75
4148307-14830776.64076.69
5113746-11374658.78058.81
681147-8114741.93441.95
15min1163893-16389384.69486.655.6784.8286.795.69
2168298-16829886.97187.10
3175994-17599490.94891.11
4177534-17753491.74491.92
5169078-16907887.37487.50
6151303-15130378.18878.28
20min1177607-17760791.78192.993.1692.0593.273.18
2182331-18233194.22394.49
3184338-18433895.26095.57
4184328-18432895.25595.58
5181579-18157993.83494.11
6169534-16953487.61087.83
30min1186567-18656796.41297.071.9296.8397.501.95
2190826-19082698.61399.04
3190498-19049898.44398.91
4189174-18917497.75998.25
5188831-18883197.58298.01
6181182-18118293.62993.99
45min1188356-18835697.33698.701.5297.9299.291.54
2193568-193568100.030100.62
3193845-193845100.173100.80
4192348-19234899.399100.05
5191052-19105298.72999.32
6186747-18674796.50597.02
60min1189513-18951397.93498.831.3898.6899.591.40
2194142-194142100.326101.09
3192972-19297299.722100.52
4191712-19171299.07099.89
5192213-19221399.329100.08
6186896-18689696.58297.26
极限1191529-19152998.97699.720.7599.89100.640.76
2195275-195275100.912101.84
3192959-19295999.715100.68
4192398-19239899.425100.41
5193975-193975100.240101.16
6191651-19165199.03999.88
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%
110.961900491902751899471898491895631899370.14
210.951904731903201903960.06
单位质量响应值RSD%判断
17330.0217387.760.24数据可信
供试品溶液-2025011721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%
5min1114928-11492859.43261.2314.5159.4361.2314.51
2111541-11154157.68057.68
3116968-11696860.48660.49
4115347-11534759.64859.65
5100393-10039351.91551.92
6151282-15128278.23178.23
10min1149474-14947477.29677.039.5777.4077.149.58
2147706-14770676.38276.48
3145419-14541975.19975.30
4145222-14522275.09775.20
5131146-13114667.81867.90
6174841-17484190.41490.54
15min1162424-16242483.99383.856.3784.2284.086.39
2161662-16166283.59983.82
3159619-15961982.54282.77
4160327-16032782.90883.13
5148418-14841876.75076.95
6180445-18044593.31293.59
20min1169791-16979187.80287.834.5988.1788.204.61
2168918-16891887.35187.71
3168606-16860687.18987.55
4168138-16813886.94787.31
5159748-15974882.60982.94
6183835-18383595.06595.50
30min1177789-17778991.93892.672.5192.4593.192.55
2178101-17810192.10092.61
3177936-17793692.01492.52
4178486-17848692.29992.81
5174933-17493390.46190.93
6188004-18800497.22197.82
45min1184311-18431195.31195.761.4495.9896.431.47
2183703-18370394.99695.66
3184515-18451595.41696.08
4185690-18569096.02496.69
5182646-18264694.45095.07
6190198-19019898.35599.11
60min1187947-18794797.19197.381.0298.0298.211.05
2187962-18796297.19998.02
3186135-18613596.25497.08
4188120-18812097.28198.10
5187812-18781297.12197.89
6191936-19193699.254100.17
极限1188443-18844397.44897.980.7298.4498.970.74
2189511-18951198.00098.98
3187655-18765597.04098.02
4189831-18983198.16599.15
5189758-18975898.12899.06
6191602-19160299.081100.17
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%
110.961900741899631897871900271894581898620.14
210.951898351900641899500.09
单位质量响应值RSD%判断
17323.1817347.030.10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%
5min157907-5790729.98630.727.5129.9930.727.51
253705-5370527.81027.81
356128-5612829.06529.06
462919-6291932.58132.58
559506-5950630.81430.81
665839-6583934.09334.09
10min1146845-14684576.04078.425.2976.0978.485.29
2142271-14227173.67273.72
3147545-14754576.40376.45
4155762-15576280.65880.71
5151373-15137378.38578.44
6164893-16489385.38685.44
15min1179627-17962793.01693.010.5193.1993.200.52
2178512-17851292.43992.61
3179117-17911792.75292.93
4179175-17917592.78292.97
5180265-18026593.34693.53
6181053-18105393.75493.95
20min1185888-18588896.25896.730.4096.5997.070.41
2186431-18643196.53996.86
3186573-18657396.61396.94
4186659-18665996.65797.00
5187261-18726196.96997.31
6188028-18802897.36697.72
30min1192139-19213999.49599.970.3799.99100.470.37
2193047-19304799.965100.45
3193191-193191100.040100.53
4192366-19236699.613100.12
5193736-193736100.322100.82
6193899-193899100.406100.92
45min1193908-193908100.411100.890.33101.07101.560.34
2195189-195189101.074101.73
3194183-194183100.553101.21
4194984-194984100.968101.64
5195469-195469101.219101.89
6195262-195262101.112101.80
60min1193698-193698100.302100.590.34101.13101.420.33
2195264-195264101.113101.93
3194636-194636100.788101.61
4193530-193530100.215101.05
5194461-194461100.697101.53
6193939-193939100.427101.28
极限1193709-193709100.308100.590.38101.30101.590.38
2195072-195072101.014102.00
3194039-194039100.479101.47
4193428-193428100.162101.17
5195235-195235101.098102.10
6194018-194018100.468101.49
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