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%
112.108365083759837638329283664836260.24
212.088368383798837400.10
单位质量响应值RSD%判断
6911.246932.120.22数据可信
供试品溶液-2025091551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%
10min148809-4880963.14761.662.8163.1561.662.81
249363-4936363.86463.86
346158-4615859.71859.72
448181-4818162.33562.33
547153-4715361.00561.00
646279-4627959.87459.87
15min154612-5461270.65568.412.5371.3669.102.50
251800-5180067.01767.73
351683-5168366.86667.53
452140-5214067.45768.15
552513-5251367.93968.62
654502-5450270.51371.18
20min157638-5763874.57071.982.7676.0673.432.73
255017-5501771.17972.63
354424-5442470.41271.82
456182-5618272.68674.13
553652-5365269.41370.85
656906-5690673.62375.07
30min159858-5985877.44275.372.2979.7677.622.28
258588-5858875.79978.04
356072-5607272.54474.73
457779-5777974.75277.00
557950-5795074.97477.18
659309-5930976.73279.00
45min163938-6393882.72179.902.2085.9082.992.19
261896-6189680.07983.17
359942-5994277.55180.55
461416-6141679.45882.54
560978-6097878.89181.93
662385-6238580.71183.83
60min163489-6348982.14081.221.6786.2385.191.63
264097-6409782.92686.90
361656-6165679.76883.62
461608-6160879.70683.67
563435-6343582.07085.98
662405-6240580.73784.75
极限163409-6340982.03680.012.5487.0484.882.48
264001-6400182.80287.70
360132-6013277.79782.54
460552-6055278.34083.19
561081-6108179.02483.85
661860-6186080.03284.95
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%
112.108417884288839708471684073842450.35
212.088388584293840890.35
单位质量响应值RSD%判断
6962.406961.010.02数据可信
供试品溶液-2025091551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%
10min129493-2949337.93840.425.1037.9440.425.10
233523-3352343.12143.12
332513-3251341.82241.82
431618-3161840.67140.67
531796-3179640.90040.90
629607-2960738.08438.08
15min159087-5908776.00575.941.6476.4376.401.62
258035-5803574.65275.13
359880-5988077.02577.49
457685-5768574.20274.65
559690-5969076.78177.24
659862-5986277.00277.43
20min164564-6456483.05081.981.6384.3283.271.62
263794-6379482.06083.37
364873-6487383.44884.77
462150-6215079.94581.22
564120-6412082.47983.79
662885-6288580.89082.17
30min170118-7011890.19486.893.1792.3889.093.11
268303-6830387.86090.08
368325-6832587.88890.14
463676-6367681.90884.07
567502-6750286.82989.05
667360-6736086.64788.82
45min171044-7104491.38690.552.5794.5893.722.52
271457-7145791.91795.11
372618-7261893.41096.63
469297-6929789.13892.21
570510-7051090.69993.89
667460-6746086.77589.92
60min173841-7384194.98392.062.2999.1996.242.25
271171-7117191.54995.77
373191-7319194.14798.41
469460-6946089.34893.41
570927-7092791.23595.43
670843-7084391.12795.23
极限170837-7083791.11991.743.4696.3896.943.34
272461-7246193.20898.44
374143-7414395.372100.68
467147-6714786.37391.43
570402-7040290.56095.77
672946-7294693.83298.95
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%
112.108435384134843638387584390842230.27
212.088501284506847590.43
单位质量响应值RSD%判断
6960.587016.470.57数据可信
供试品溶液-2025091551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%
10min154759-5475970.16969.031.5970.1769.031.59
252786-5278667.64067.64
353168-5316868.13068.13
453523-5352368.58568.58
554879-5487970.32270.32
654093-5409369.31569.32
15min159156-5915675.80374.782.8676.5875.542.85
256281-5628172.11972.87
357346-5734673.48474.24
457241-5724173.34974.11
560744-6074477.83878.62
659362-5936276.06776.84
20min162623-6262380.24677.682.3081.8779.282.29
259259-5925975.93577.49
359696-5969676.49578.07
459395-5939576.10977.69
561756-6175679.13580.78
660985-6098578.14779.76
30min166584-6658485.32181.053.7987.8383.513.73
260115-6011577.03279.43
361320-6132078.57681.00
462743-6274380.39982.82
563610-6361081.51084.04
665147-6514783.48085.96
45min168589-6858987.89084.082.6991.3587.442.65
263964-6396481.96485.22
366408-6640885.09688.39
463826-6382681.78785.10
565224-6522483.57887.01
665688-6568884.17387.58
60min168813-6881388.17783.532.9092.6287.832.84
264808-6480883.04587.21
363865-6386581.83786.08
464232-6423282.30786.53
565531-6553183.97288.33
663875-6387581.85086.20
极限167684-6768486.73184.161.6092.1589.381.62
265750-6575084.25289.34
365111-6511183.43488.58
464658-6465882.85387.99
565503-6550383.93689.23
665366-6536683.76089.02
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