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(%)99.74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%
111.262000912003742002412004992002082002830.08
211.322033702037492035600.14
单位质量响应值RSD%判断
17787.1217982.330.78数据可信
供试品溶液-24071601批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min187916-8791644.12849.497.6744.1349.497.67
2109713-10971355.06855.07
393309-9330946.83546.83
497382-9738248.87948.88
5101358-10135850.87550.87
6101883-10188351.13851.14
10min1140733-14073370.63873.833.6270.7173.913.62
2152858-15285876.72476.82
3142104-14210471.32671.40
4144796-14479672.67772.76
5149173-14917374.87474.96
6152844-15284476.71776.80
15min1162935-16293581.78284.091.9781.9784.301.98
2172610-17261086.63886.86
3165924-16592483.28283.48
4166510-16651083.57683.78
5167767-16776784.20784.42
6169445-16944585.04985.26
20min1175228-17522887.95290.021.6088.2890.361.61
2183566-18356692.13792.50
3178734-17873489.71290.05
4178103-17810389.39589.74
5179006-17900689.84890.20
6181409-18140991.05491.41
30min1189152-18915294.94196.471.2395.4296.971.24
2194725-19472597.73898.26
3191686-19168696.21396.70
4193401-19340197.07497.56
5189819-18981995.27695.78
6194398-19439897.57498.08
45min1195251-19525198.00299.951.8798.63100.601.88
2203618-203618102.202102.88
3198194-19819499.479100.12
4195974-19597498.36599.02
5197910-19791099.337100.00
6203789-203789102.288102.96
60min1197358-19735899.060100.611.3299.86101.441.33
2203370-203370102.077102.93
3201796-201796101.287102.10
4198500-19850099.633100.45
5198502-19850299.634100.46
6203162-203162101.973102.81
极限1197840-19784099.302101.772.33100.26102.762.33
2203896-203896102.341103.36
3202465-202465101.623102.60
4199459-199459100.114101.10
5201595-201595101.186102.18
6211338-211338106.077107.09
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(%)99.74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%
111.262016292019212017582019122019092018260.07
211.322014572013362013960.05
单位质量响应值RSD%判断
17924.1617791.170.53数据可信
供试品溶液-24071601批-pH6.8(内含0.1%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124210-2421012.17012.1125.8412.1712.1225.84
228936-2893614.54614.55
313227-132276.6496.65
427733-2773313.94113.94
529513-2951314.83614.84
620981-2098110.54710.55
10min150380-5038025.32523.0124.1325.3523.0324.13
248008-4800824.13324.16
324292-2429212.21112.22
450907-5090725.59025.61
555533-5553327.91527.94
645478-4547822.86122.88
15min168805-6880534.58733.0715.6534.6533.1315.66
260721-6072130.52330.59
347062-4706223.65723.69
472311-7231136.34936.42
573148-7314836.77036.84
672704-7270436.54736.60
20min187012-8701243.73943.089.2343.8643.209.24
275392-7539237.89838.01
376690-7669038.55138.62
492204-9220446.34946.48
588817-8881744.64744.78
694137-9413747.32147.44
30min1119672-11967260.15759.553.5560.3559.743.56
2111553-11155356.07656.25
3115824-11582458.22358.36
4121916-12191661.28561.49
5118966-11896659.80260.01
6122905-12290561.78261.98
45min1153992-15399277.40976.152.2277.7076.442.21
2157016-15701678.92979.20
3148222-14822274.50974.74
4149340-14934075.07175.38
5149561-14956175.18275.49
6150813-15081375.81176.11
60min1167858-16785884.37983.710.9084.8084.120.90
2168581-16858184.74385.15
3164956-16495682.92083.28
4165060-16506082.97383.40
5166781-16678183.83884.27
6165939-16593983.41583.84
极限1182999-18299991.99091.070.7792.5591.620.78
2181645-18164591.31091.85
3179505-17950590.23490.73
4180536-18053690.75291.32
5182391-18239191.68592.26
6179986-17998690.47691.04
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(%)99.74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%
111.262006132008912006532005472007092006830.07
211.322011542008892010220.10
单位质量响应值RSD%判断
17822.6517758.130.26数据可信
供试品溶液-24071601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%
5min12264-22641.1421.0931.311.141.0931.32
23318-33181.6741.67
32177-21771.0981.10
41218-12180.6150.61
51973-19730.9961.00
62022-20221.0201.02
10min126818-2681813.53211.7817.6413.5311.7917.63
227997-2799714.12714.13
326003-2600313.12113.12
418767-187679.4699.47
521735-2173510.96710.97
618815-188159.4949.50
15min136553-3655318.44417.2314.8118.4717.2514.82
239727-3972720.04520.07
338602-3860219.47819.50
427087-2708713.66713.68
533311-3331116.80816.83
629622-2962214.94714.96
20min142323-4232321.35520.359.0121.4120.409.03
244972-4497222.69222.75
342342-4234221.36521.42
435475-3547517.90017.94
540143-4014320.25520.30
636747-3674718.54218.58
30min150001-5000125.22923.558.4025.3223.648.42
250277-5027725.36925.47
349299-4929924.87524.97
441524-4152420.95221.02
546710-4671023.56923.65
642277-4227721.33221.41
45min155254-5525427.88026.526.8128.0126.646.84
255503-5550328.00628.15
355275-5527527.89128.02
448910-4891024.67924.78
553075-5307526.78026.90
647352-4735223.89324.00
60min158634-5863429.58528.785.7929.7628.955.81
259980-5998030.26530.45
359206-5920629.87430.05
454061-5406127.27827.42
558589-5858929.56329.73
651815-5181526.14526.29
极限164681-6468132.63731.315.3332.8731.525.35
264459-6445932.52532.76
364893-6489332.74432.97
459095-5909529.81830.01
562125-6212531.34731.56
657056-5705628.78928.98
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