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%
111.307966079318794417958379294794590.21
211.287944579842796440.36
单位质量响应值RSD%判断
7031.777060.640.29数据可信
供试品溶液-25090901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%
10min131765-3176540.37033.7725.5340.3733.7725.53
233059-3305942.01542.01
319045-1904524.20424.20
430217-3021738.40338.40
517165-1716521.81521.82
628187-2818735.82335.82
15min152124-5212466.24565.735.4666.6966.105.36
246468-4646859.05659.52
354120-5412068.78169.05
453997-5399768.62569.05
552539-5253966.77267.01
651045-5104564.87365.27
30min159117-5911775.13273.326.1576.3274.426.07
250562-5056264.25965.38
359076-5907675.08076.11
460054-6005476.32377.51
558103-5810373.84374.83
659220-5922075.26376.38
45min158234-5823474.01078.414.7276.0380.334.60
263708-6370880.96782.80
363996-6399681.33383.20
465087-6508782.71984.76
560096-6009676.37678.18
659062-5906275.06277.02
60min163623-6362380.85983.562.8083.7086.352.77
265260-6526082.93985.68
367418-6741885.68288.45
468462-6846287.00989.96
564440-6444081.89784.55
665287-6528782.97385.76
90min168896-6889687.56086.432.5091.3090.152.43
269879-6987988.80992.47
368749-6874987.37391.10
467156-6715685.34989.27
565046-6504682.66786.23
668322-6832286.83190.54
120min168886-6888687.54788.502.5292.2693.182.43
268635-6863587.22891.87
373042-7304292.82997.52
469465-6946588.28393.15
568178-6817886.64891.13
669630-6963088.49393.17
极限169220-6922087.97288.551.6493.6694.221.67
270042-7004289.01794.63
370109-7010989.10294.83
470956-7095690.17896.03
567649-6764985.97591.42
670096-7009689.08594.74
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%
111.307978679500796147961979329795700.22
211.287930379326793140.03
单位质量响应值RSD%判断
7041.597031.380.11数据可信
供试品溶液-25090902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%
10min127401-2740134.87235.286.9334.8735.286.93
227469-2746934.95834.96
324262-2426230.87730.88
428975-2897536.87536.88
528431-2843136.18336.18
629770-2977037.88737.89
15min150655-5065564.46665.093.5264.8565.483.46
251754-5175465.86566.25
354318-5431869.12869.47
450863-5086364.73165.14
550278-5027863.98664.39
648980-4898062.33562.76
30min158310-5831074.20874.134.3375.3175.254.26
258796-5879674.82775.95
362050-6205078.96880.08
458157-5815774.01475.14
554133-5413368.89370.01
658055-5805573.88475.00
45min158732-5873274.74578.174.7176.6780.114.62
261491-6149178.25780.21
366839-6683985.06387.05
460949-6094977.56779.52
561314-6131478.03179.91
659207-5920775.35077.28
60min163060-6306080.25383.234.0883.0186.044.01
263698-6369881.06583.89
370441-7044189.64792.58
465514-6551483.37786.19
565564-6556483.44086.19
664102-6410281.58084.35
90min167837-6783786.33386.166.6289.9889.896.44
267540-6754085.95589.68
375599-7559996.211100.14
466400-6640084.50488.24
567113-6711385.41289.08
661711-6171178.53782.21
120min164110-6411081.59085.125.7886.2089.815.64
267524-6752485.93590.61
373307-7330793.29498.29
467611-6761186.04590.72
566842-6684285.06789.69
661917-6191778.79983.35
极限170475-7047589.69086.964.8095.2192.594.69
267624-6762486.06291.69
372717-7271792.54398.58
468732-6873287.47293.11
567406-6740685.78491.35
663002-6300280.18085.61
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%
111.307978979541796457946579604796090.16
211.287894978988789680.04
单位质量响应值RSD%判断
7045.047000.710.45数据可信
供试品溶液-25090903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%
10min129718-2971837.89443.226.9637.8943.226.96
232906-3290641.95941.96
335969-3596945.86545.87
433998-3399843.35243.35
535929-3592945.81445.81
634842-3484244.42844.43
15min149998-4999863.75466.344.5264.1866.824.51
248786-4878662.20962.67
353388-5338868.07768.59
454639-5463969.67270.15
551352-5135265.48165.99
653979-5397968.83069.32
30min155734-5573471.06873.462.5772.2074.672.56
257479-5747973.29374.45
356859-5685972.50373.77
457640-5764073.49974.75
560216-6021676.78378.02
657708-5770873.58574.84
45min158947-5894775.16579.073.5177.0881.113.49
261394-6139478.28580.26
363581-6358181.07483.15
462490-6249079.68381.76
565044-6504482.94085.03
660616-6061677.29379.37
60min162896-6289680.20182.922.7682.9585.842.76
263738-6373881.27484.12
365982-6598284.13687.11
463898-6389881.47884.44
567570-6757086.16189.17
666106-6610684.29487.23
90min166393-6639384.66088.823.1688.3192.653.14
269113-6911388.12891.87
370896-7089690.40294.31
470424-7042489.80093.66
572727-7272792.73696.71
668379-6837987.19291.06
120min167544-6754486.12786.885.1290.7191.704.87
268416-6841687.23991.96
361707-6170778.68583.60
469251-6925188.30493.17
571923-7192391.71196.71
669944-6994489.18894.03
极限168070-6807086.79886.834.2292.3492.624.02
263908-6390881.49187.18
371778-7177891.52697.31
469284-6928488.34694.19
569838-6983889.05395.07
665712-6571283.79189.62
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