布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.038411583890838168362083813838510.22
211.048452884271844000.22
单位质量响应值RSD%判断
7602.097644.930.40数据可信
供试品溶液-25090501批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min129988-2998835.22634.3421.8535.2334.3521.84
231094-3109436.52536.53
335685-3568541.91841.92
434344-3434440.34340.34
526157-2615730.72630.73
618158-1815821.33021.33
15min167634-6763479.44779.922.4179.8480.302.38
269541-6954181.68782.09
367322-6732279.08179.55
468581-6858180.56081.01
565360-6536076.77677.12
669780-6978081.96882.21
20min173490-7349086.32686.751.5887.6088.011.52
274669-7466987.71189.02
373406-7340686.22887.57
472853-7285385.57886.92
572861-7286185.58786.78
675801-7580189.04190.19
30min175913-7591389.17287.601.6291.4189.841.55
272495-7249585.15787.45
374504-7450487.51789.82
474779-7477987.84090.13
574206-7420687.16789.31
675555-7555588.75290.89
45min176601-7660189.98189.852.4193.2093.062.35
277861-7786191.46194.69
374954-7495488.04691.32
477626-7762691.18594.45
573628-7362886.48889.60
678292-7829291.96795.09
60min175808-7580889.04987.712.5793.2791.922.47
273525-7352586.36790.62
375509-7550988.69892.95
473846-7384686.74491.03
571985-7198584.55888.63
677351-7735190.86295.01
极限171073-7107383.48786.322.2588.7091.502.13
275278-7527888.42693.64
372097-7209784.69089.93
475098-7509888.21593.46
573558-7355886.40691.42
673793-7379386.68291.84
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.038515084740851698468584806849100.28
211.048498984702848460.24
单位质量响应值RSD%判断
7698.107685.330.12数据可信
供试品溶液-25090502批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min134908-3490840.64133.6032.9740.6433.6032.97
215063-1506317.53717.54
339436-3943645.91345.91
427254-2725431.73031.73
535687-3568741.54841.55
620821-2082124.24124.24
15min169242-6924280.61481.072.4681.0781.442.35
269563-6956380.98881.18
366840-6684077.81878.33
471403-7140383.13083.48
569292-6929280.67381.13
671467-7146783.20583.47
20min172174-7217484.02882.082.5985.3883.352.65
268252-6825279.46280.56
370512-7051282.09383.47
468883-6888380.19681.47
572954-7295484.93686.29
670215-7021581.74782.94
30min172849-7284984.81484.082.3587.0986.262.34
272371-7237184.25786.23
372348-7234884.23186.52
469090-6909080.43782.60
574237-7423786.43088.73
672421-7242184.31686.42
45min173295-7329585.33385.112.4488.5688.232.42
273088-7308885.09288.01
372890-7289084.86288.08
474125-7412586.29989.36
575261-7526187.62290.88
669942-6994281.42984.47
60min174052-7405286.21485.582.3790.3989.652.37
270384-7038481.94485.80
372748-7274884.69688.86
474431-7443186.65690.68
575311-7531187.68091.92
674131-7413186.30690.25
极限173509-7350985.58283.402.3390.7188.422.20
273182-7318285.20189.97
372670-7267084.60589.71
469928-6992881.41386.40
570637-7063782.23887.45
669900-6990081.38086.28
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