布瑞派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%
111.098011279803799137958379557797940.30
211.128019180252802220.06
单位质量响应值RSD%判断
7195.137214.210.19数据可信
供试品溶液-2025091551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%
10min127824-2782434.58435.8912.4034.5835.8912.40
229630-2963036.82836.83
327253-2725333.87433.87
435306-3530643.88343.88
524597-2459730.57330.57
628637-2863735.59435.59
15min151926-5192664.54160.824.7164.9361.224.62
248479-4847960.25760.67
348961-4896160.85661.23
446273-4627357.51558.00
551229-5122963.67564.01
646705-4670558.05258.45
30min155525-5552569.01566.394.9870.1267.474.94
255524-5552469.01370.09
349851-4985161.96263.01
455202-5520268.61369.74
554135-5413567.28768.33
650259-5025962.46963.51
45min161141-6114175.99571.538.6077.8673.348.46
259286-5928673.68975.53
356267-5626769.93771.68
461182-6118276.04677.93
559273-5927373.67375.47
648142-4814259.83861.57
60min165293-6529381.15676.035.6583.8778.645.61
263391-6339178.79281.46
357947-5794772.02574.54
462263-6226377.39080.12
562001-6200177.06479.68
656135-5613569.77372.17
90min167803-6780384.27577.409.3987.8980.869.00
266644-6664482.83586.37
359130-5913073.49576.81
452129-5212964.79468.39
565119-6511980.93984.41
662826-6282678.08981.26
120min164058-6405879.62176.185.7184.1780.495.49
260593-6059375.31479.77
357276-5727671.19175.33
466509-6650982.66786.98
558199-5819972.33876.71
661092-6109275.93479.98
极限169866-6986686.84077.7810.0592.2882.949.63
260951-6095175.75981.06
360832-6083275.61180.54
468049-6804984.58189.81
563561-6356179.00384.18
652199-5219964.88169.77
布瑞派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%
111.098004980019801527968880349800510.31
211.127992979940799340.01
单位质量响应值RSD%判断
7218.307188.310.30数据可信
供试品溶液-2025091551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%
10min125310-2531031.46532.1919.2731.4632.1919.27
224359-2435930.28330.28
317760-1776022.07922.08
428483-2848335.41035.41
532850-3285040.83940.84
626603-2660333.07233.07
15min146289-4628957.54658.208.9357.9058.568.86
246987-4698758.41458.75
351514-5151464.04164.29
444247-4424755.00755.40
551246-5124663.70864.16
640593-4059350.46550.83
30min156851-5685170.67663.8210.0471.6764.839.97
247672-4767259.26560.25
350967-5096763.36164.32
451454-5145463.96764.97
557152-5715271.05072.21
643935-4393554.61955.55
45min153867-5386766.96769.977.5168.7471.697.42
251495-5149564.01865.66
360762-6076275.53877.20
453605-5360566.64168.36
562032-6203277.11779.07
655951-5595169.55771.09
60min164405-6440580.06774.998.5582.5977.488.44
253905-5390567.01469.37
364685-6468580.41582.92
455220-5522068.64971.10
565422-6542281.33284.14
658303-5830372.48174.79
90min168785-6878585.51282.074.4288.9285.394.09
266082-6608282.15285.25
366559-6655982.74586.14
464243-6424379.86683.08
561337-6133776.25379.96
669094-6909485.89789.01
120min169059-6905985.85382.565.5590.2186.805.30
265974-6597482.01886.03
370534-7053487.68792.00
468606-6860685.29089.40
563174-6317478.53783.10
661100-6110075.95980.03
极限168829-6882985.56778.827.7290.8883.987.37
260889-6088975.69680.62
367168-6716883.50288.79
466729-6672982.95688.01
560483-6048375.19280.62
656323-5632370.02074.93
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