布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
1 11.088277182746825628237782369825650.24
2 10.968252382618825700.09
单位质量响应值RSD%判断
7451.717533.760.78数据可信
供试品溶液-25061901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%
10min125526-2552630.50933.0915.3930.5133.1015.39
230856-3085636.87936.88
329690-2969035.48535.49
430311-3031136.22836.23
529842-2984235.66735.67
619911-1991123.79723.80
15min153815-5381564.31974.797.3564.4974.987.33
265163-6516377.88278.09
361236-6123673.18973.39
464169-6416976.69476.90
565166-6516677.88678.08
665911-6591178.77678.91
20min159097-5909770.63283.879.2271.1684.479.19
270958-7095884.80985.45
368672-6867282.07682.68
478992-7899294.41195.04
570840-7084084.66785.30
672471-7247186.61787.19
30min159962-5996271.66683.377.1372.5984.447.12
273731-7373188.12389.23
372496-7249686.64787.71
470461-7046184.21585.37
571632-7163285.61486.72
670248-7024883.96085.01
45min163489-6348975.88286.906.9977.2088.436.97
272188-7218886.27987.88
372043-7204386.10587.65
477137-7713792.19493.81
573992-7399288.43590.01
677410-7741092.52094.04
60min166069-6606978.96587.916.2580.7089.926.24
270596-7059684.37686.45
373650-7365088.02690.05
475568-7556890.31892.45
578730-7873094.09896.17
676715-7671591.68993.72
极限165152-6515277.86989.496.8480.0592.006.83
276881-7688191.88894.43
373325-7332587.63890.15
478937-7893794.34596.98
577355-7735592.45495.05
677615-7761592.76595.31
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
1 11.088242982406826238262882444825060.14
2 10.968273482425825800.27
单位质量响应值RSD%判断
7446.397534.670.84数据可信
供试品溶液-25061901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%
10min124942-2494229.81930.6616.3629.8230.6616.36
219145-1914522.88922.89
323795-2379528.44828.45
429249-2924934.96934.97
531013-3101337.07837.08
625723-2572330.75330.75
15min161658-6165873.71573.466.1773.8873.636.18
254946-5494665.69165.82
363876-6387676.36776.53
459234-5923470.81771.01
564179-6417976.72976.94
664785-6478577.45477.62
20min168749-6874982.19382.465.1282.7783.045.12
263657-6365776.10576.60
370105-7010583.81484.40
468925-6892582.40382.99
567852-6785281.12181.75
674570-7457089.15289.75
30min172215-7221586.33786.954.2887.3787.994.26
271524-7152485.51186.43
371055-7105584.95086.00
469892-6989283.55984.60
572992-7299287.26688.35
678704-7870494.09595.19
45min176770-7677091.78290.753.2593.2992.273.25
273587-7358787.97789.37
377698-7769892.89294.41
472409-7240986.56988.08
576124-7612491.01092.58
678849-7884994.26895.89
60min173505-7350587.87988.744.3189.9090.764.31
270031-7003183.72685.60
374765-7476589.38591.42
472183-7218386.29888.29
575465-7546590.22292.30
679409-7940994.93897.08
极限174167-7416788.67088.712.0991.1891.232.11
272753-7275386.98089.32
376477-7647791.43293.96
472412-7241286.57289.04
573994-7399488.46491.04
675403-7540390.14892.82
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
1 11.088274782630824198233182653825560.22
2 10.968298982549827690.38
单位质量响应值RSD%判断
7450.907551.920.96数据可信
供试品溶液-25062302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%
10min164842-6484277.41075.083.7977.4175.083.79
264176-6417676.61576.62
360648-6064872.40372.40
464509-6450977.01377.01
559163-5916370.63170.63
664014-6401476.42276.42
15min170295-7029583.92081.753.6284.3582.173.62
269349-6934982.79183.22
365656-6565678.38278.78
469435-6943582.89483.32
565133-6513377.75878.15
671014-7101484.77985.20
20min172133-7213386.11584.073.2487.0184.943.24
272260-7226086.26687.15
367851-6785181.00381.84
470840-7084084.57185.46
567294-6729480.33881.16
672159-7215986.14687.04
30min174647-7464789.11687.473.9390.4988.813.92
273708-7370887.99589.36
369058-6905882.44383.73
476255-7625591.03592.39
570474-7047484.13485.40
675478-7547890.10891.48
45min173956-7395688.29188.614.1290.1690.444.10
276278-7627891.06392.92
370676-7067684.37586.12
478112-7811293.25295.12
570684-7068484.38586.12
675658-7565890.32392.20
60min174106-7410688.47088.624.3790.8390.944.34
274266-7426688.66191.02
370677-7067784.37686.59
478193-7819393.34995.73
570595-7059584.27886.49
677540-7754092.57094.95
极限176170-7617090.93489.104.2693.7991.914.25
276072-7607290.81793.67
370681-7068184.38187.06
478179-7817993.33296.23
570651-7065184.34587.02
676070-7607090.81593.71
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
1 11.088513085242852688504585260851890.12
2 10.968264482483825640.14
单位质量响应值RSD%判断
7688.547533.211.45数据可信
供试品溶液-25062302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%
10min161769-6176972.68569.518.1872.6969.518.18
262237-6223773.23673.24
360255-6025570.90470.90
449365-4936558.08958.09
560304-6030470.96170.96
660498-6049871.19071.19
15min166745-6674578.54178.592.7478.9478.982.75
267322-6732279.22079.63
366633-6663378.40978.80
463824-6382475.10475.43
566677-6667778.46178.85
669530-6953081.81882.21
20min170044-7004482.42382.113.2583.2682.933.26
271559-7155984.20685.05
369598-6959881.89882.73
465417-6541776.97877.72
570660-7066083.14883.98
671380-7138083.99584.84
30min169368-6936881.62785.093.1282.9386.373.10
271791-7179184.47985.79
373026-7302685.93287.22
470757-7075783.26284.43
573027-7302785.93387.23
675909-7590989.32490.64
45min172730-7273085.58387.472.6387.3389.222.64
274418-7441887.57089.35
374257-7425787.38089.14
471804-7180484.49486.12
575546-7554688.89790.67
677254-7725490.90792.72
60min173610-7361086.61988.061.9788.8590.301.99
275081-7508188.35090.62
374770-7477087.98490.23
472898-7289885.78187.88
575604-7560488.96591.23
677047-7704790.66392.98
极限174509-7450987.67788.592.4090.3991.322.41
276629-7662990.17292.93
374706-7470687.90990.64
472814-7281485.68288.26
575065-7506588.33191.09
677993-7799391.77794.60
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