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%
111.069283092694931379296592925929100.18
211.059367193539936050.10
单位质量响应值RSD%判断
8400.548471.040.60数据可信
供试品溶液-25052602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%
5min12883-28833.06012.79127.843.0612.79127.83
241780-4178044.35244.35
37288-72887.7377.74
42698-26982.8642.86
515454-1545416.40516.41
62203-22032.3392.34
10min147570-4757050.49945.1818.2650.5045.2018.28
248340-4834051.31651.39
346918-4691849.80749.82
429310-2931031.11531.12
546452-4645249.31249.34
636760-3676039.02339.03
15min153895-5389557.21355.196.6057.3055.286.63
253711-5371157.01857.18
354458-5445857.81157.91
450893-5089354.02654.08
553499-5349956.79356.90
645461-4546148.26048.33
20min157561-5756161.10559.234.8461.2959.424.85
256705-5670560.19660.45
357310-5731060.83861.03
455977-5597759.42359.57
556795-5679560.29260.50
650403-5040353.50653.66
30min160300-6030064.01262.683.9764.3062.973.99
259618-5961863.28863.64
362032-6203265.85166.14
458818-5881862.43962.68
558505-5850562.10762.41
655014-5501458.40158.64
45min163870-6387067.80265.912.8968.2066.312.90
262146-6214665.97266.43
363562-6356267.47567.88
462201-6220166.03166.38
561938-6193865.75166.16
658828-5882862.45062.79
60min167084-6708471.21468.883.1571.7269.383.18
265967-6596770.02870.60
366393-6639370.48171.00
464233-6423368.18868.65
564173-6417368.12468.64
661478-6147865.26365.70
极限168063-6806372.25370.382.8872.8871.002.91
267344-6734471.49072.18
367872-6787272.05172.68
465744-6574469.79270.37
565795-6579569.84670.48
662986-6298666.86467.41
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%
111.069315693198931099331593035931630.12
211.059434693173937600.89
单位质量响应值RSD%判断
8423.428485.070.52数据可信
供试品溶液-25052102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%
5min12951-29513.12611.29121.653.1311.29121.63
28870-88709.3969.40
39314-93149.8669.87
436100-3610038.23938.24
5-0.0000.00
66726-67267.1247.12
10min140994-4099443.42344.916.0843.4344.926.12
244341-4434146.96846.98
343322-4332245.88945.91
445800-4580048.51348.58
538724-3872441.01841.02
641181-4118143.62143.63
15min146652-4665249.41651.343.7149.4951.433.73
250250-5025053.22753.32
349833-4983352.78552.88
449372-4937252.29752.44
545861-4586148.57848.65
648837-4883751.73051.81
20min149085-4908551.99354.443.9952.1554.624.00
253891-5389157.08457.27
352690-5269055.81255.99
452115-5211555.20355.43
548748-4874851.63651.79
651816-5181654.88655.06
30min153457-5345756.62457.384.1556.8757.654.15
257446-5744660.84961.13
355717-5571759.01859.29
453875-5387557.06757.39
550812-5081253.82254.06
653718-5371856.90157.16
45min155548-5554858.83960.143.6059.1860.513.61
259879-5987963.42763.81
357938-5793861.37161.74
457050-5705060.43060.85
553938-5393857.13457.46
656326-5632659.66360.02
60min158019-5801961.45662.603.7061.9063.063.71
262372-6237266.06766.55
359611-5961163.14363.62
460339-6033963.91464.43
556049-5604959.37059.79
658184-5818461.63162.09
极限161037-6103764.65363.973.1965.1964.543.21
262848-6284866.57167.17
361359-6135964.99465.57
460919-6091964.52865.15
557656-5765661.07261.59
658545-5854562.01462.57
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%
111.069343893662932659276192884932020.41
211.059356393325934440.19
单位质量响应值RSD%判断
8426.948456.470.25数据可信
供试品溶液-25052103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%
5min113382-1338214.19613.44105.5114.2013.44105.51
22520-25202.6732.67
32929-29293.1073.11
43704-37043.9293.93
516292-1629217.28317.28
637198-3719839.46039.46
10min149718-4971852.74144.9318.5352.7644.9618.55
241182-4118243.68643.69
329912-2991231.73131.74
436956-3695639.20339.21
547906-4790650.81950.85
648464-4846451.41151.48
15min158931-5893162.51456.287.3662.6356.387.38
250362-5036253.42453.50
349522-4952252.53352.59
451003-5100354.10454.18
556974-5697460.43860.55
651524-5152454.65754.81
20min162100-6210065.87661.035.2266.0961.225.21
257033-5703360.50160.67
355001-5500158.34558.49
457088-5708860.55960.72
559850-5985063.48963.70
654093-5409357.38257.62
30min164868-6486868.81264.324.4669.1464.614.46
258849-5884962.42762.69
361070-6107064.78465.03
458502-5850262.05962.32
562526-6252666.32866.65
657966-5796661.49161.83
45min167738-6773871.85768.114.2372.3068.514.22
263815-6381567.69568.07
366319-6631970.35270.70
461191-6119164.91265.28
565121-6512169.08169.51
661067-6106764.78065.22
60min172134-7213476.52071.794.0277.0872.304.00
267277-6727771.36871.85
369260-6926073.47273.94
465556-6555669.54270.02
567260-6726071.35071.90
664554-6455468.47969.03
极限173882-7388278.37573.834.2279.0674.474.20
268599-6859972.77073.37
370036-7003674.29574.89
469756-6975673.99874.59
570501-7050174.78875.45
664833-6483368.77569.44
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%
111.069335793925933819294793268933760.38
211.059281093062929360.20
单位质量响应值RSD%判断
8442.688410.500.28数据可信
供试品溶液-25052602批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min14565-45654.8510.81244.954.850.81244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min16168-61686.5556.4122.556.566.4122.58
28184-81848.6978.70
36500-65006.9086.91
45047-50475.3645.36
56093-60936.4756.48
64187-41874.4504.45
20min110022-1002210.65010.1221.5910.6710.1321.58
29749-974910.36010.37
312977-1297713.79113.80
46701-67017.1217.13
58734-87349.2829.29
68964-89649.5269.53
30min111161-1116111.86112.9512.3511.9012.9712.35
214201-1420115.09215.12
313989-1398914.86614.90
411140-1114011.83911.86
511685-1168512.41812.44
610917-1091711.60211.62
45min113138-1313813.96214.4210.9014.0214.4710.90
216199-1619917.21517.27
313839-1383914.70714.77
411917-1191712.66412.70
512574-1257413.36313.41
613735-1373514.59614.64
60min113802-1380214.66815.779.6814.7515.849.67
217055-1705518.12518.21
315395-1539516.36016.44
412891-1289113.69913.76
515245-1524516.20116.27
614628-1462815.54515.61
极限114007-1400714.88516.6410.4114.9916.7410.39
218632-1863219.80019.92
315749-1574916.73716.85
415033-1503315.97616.06
514562-1456215.47515.57
615978-1597816.98017.07
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