布瑞哌唑口服混悬液项目信息
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5000
标示量(mg)2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%
110.879389993886941009354393806938470.22
210.869394993410936800.41
单位质量响应值RSD%判断
8633.588626.150.07数据可信
供试品溶液-25052601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%
5min151307-5130753.24054.282.3153.2454.282.31
250551-5055152.45652.46
353892-5389255.92255.92
452784-5278454.77354.77
552978-5297854.97454.97
652319-5231954.29054.29
10min163466-6346665.85767.303.6065.9567.393.59
266612-6661269.12269.21
365195-6519567.65167.74
461160-6116063.46463.56
567749-6774970.30170.39
664960-6496067.40767.50
15min170003-7000372.64070.374.1172.8470.584.10
267901-6790170.45970.66
363118-6311865.49665.70
466432-6643268.93569.13
570899-7089973.57073.78
668558-6855871.14171.34
20min169733-6973372.36073.702.0272.6874.022.01
271103-7110373.78274.10
372548-7254875.28175.60
468946-6894671.54471.86
572327-7232775.05275.38
671477-7147774.17074.49
30min171595-7159574.29275.393.3374.7375.843.31
274740-7474077.55678.00
373999-7399976.78777.23
472190-7219074.91075.34
568548-6854871.13171.59
674854-7485477.67478.12
45min179349-7934982.33981.021.6782.9081.591.65
277918-7791880.85481.43
378863-7886381.83482.40
476661-7666179.54980.11
579264-7926482.25082.83
676423-7642379.30279.88
60min179697-7969782.70082.332.3783.4083.042.35
281174-8117484.23284.94
378890-7889081.86282.57
479115-7911582.09682.78
581113-8111384.16984.88
676074-7607478.94079.65
极限180227-8022783.25083.834.3284.0984.674.28
283876-8387687.03687.88
382386-8238685.49086.33
481864-8186484.94885.77
582300-8230085.40186.25
674091-7409176.88277.72
布瑞哌唑口服混悬液项目信息
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5000
标示量(mg)2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%
110.879337593499933419353293371934240.10
210.869368893932938100.19
单位质量响应值RSD%判断
8594.668638.120.36数据可信
供试品溶液-25052602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%
5min161242-6124263.64962.153.3663.6562.153.36
259725-5972562.07262.07
360891-6089163.28463.28
460094-6009462.45662.46
560985-6098563.38263.38
655874-5587458.07058.07
10min171061-7106173.85470.488.2273.9670.588.21
257853-5785360.12760.23
369444-6944472.17372.28
470499-7049973.27073.37
573070-7307075.94276.05
664968-6496867.52267.62
15min175980-7598078.96676.954.9779.2077.174.97
274028-7402876.93877.14
374653-7465377.58777.81
475479-7547978.44678.67
577219-7721980.25480.49
666879-6687969.50869.72
20min178977-7897782.08180.235.1582.4480.585.14
277693-7769380.74781.08
381013-8101384.19784.55
476040-7604079.02979.39
579597-7959782.72683.09
669862-6986272.60872.93
30min178694-7869481.78784.034.5582.2884.514.54
281859-8185985.07685.54
385375-8537588.73189.23
481143-8114384.33284.82
583161-8316186.43086.93
674864-7486477.80778.25
45min188491-8849191.96987.884.6692.6088.504.65
284544-8454487.86788.48
386857-8685790.27190.91
484408-8440887.72688.35
585899-8589989.27589.92
677153-7715380.18580.76
60min188888-8888892.38291.774.6393.1792.544.62
289371-8937192.88493.64
391694-9169495.29896.09
489983-8998393.52094.30
589671-8967193.19593.99
680198-8019883.35084.06
极限192208-9220895.83291.793.8996.7792.723.89
287341-8734190.77491.68
390438-9043893.99394.95
487788-8778891.23892.17
589805-8980593.33594.29
682343-8234385.57986.43
布瑞哌唑口服混悬液项目信息
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5000
标示量(mg)2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%
110.879333193643933789341293910935350.26
210.869341693888936520.36
单位质量响应值RSD%判断
8604.888623.570.16数据可信
供试品溶液-25052603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%
5min172487-7248775.35572.555.2575.3572.555.25
270486-7048673.27473.27
373009-7300975.89775.90
462878-6287865.36665.37
570713-7071373.51073.51
669172-6917271.90971.91
10min178242-7824281.33780.621.9081.4680.741.90
277735-7773580.81080.93
376385-7638579.40779.53
475724-7572478.72078.83
577345-7734580.40580.53
679910-7991083.07183.19
15min178809-7880981.92782.241.5582.1982.501.54
278890-7889082.01182.27
381473-8147384.69684.95
478648-7864881.75982.00
578982-7898282.10782.36
677884-7788480.96581.22
20min184576-8457687.92284.412.1988.3284.802.18
281234-8123484.44884.84
381054-8105484.26184.66
480765-8076583.96084.34
579796-7979682.95383.35
679749-7974982.90483.30
30min182420-8242085.68186.472.7186.2287.002.70
285441-8544188.82189.36
386050-8605089.45489.99
480294-8029483.47183.99
581463-8146384.68685.22
683417-8341786.71787.25
45min186540-8654089.96488.651.5690.6589.321.55
287173-8717390.62291.30
384406-8440687.74588.43
484384-8438487.72288.38
583864-8386487.18287.85
685291-8529188.66589.34
60min185600-8560088.98688.892.6889.8289.712.65
281099-8109984.30785.14
387554-8755491.01891.85
485505-8550588.88889.69
586768-8676890.20191.02
686495-8649589.91790.74
极限189148-8914892.67590.741.9593.6691.721.94
289127-8912792.65393.63
387553-8755391.01792.00
485480-8548088.86289.81
587203-8720390.65391.62
685222-8522288.59389.57
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