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%
111.988365083759837638329283664836260.24
211.898368383798837400.10
单位质量响应值RSD%判断
6980.477042.890.63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%
10min148809-4880962.33860.872.8162.3460.872.81
249363-4936363.04563.05
346158-4615858.95258.95
448181-4818161.53661.54
547153-4715360.22360.22
646279-4627959.10759.11
15min154612-5461269.74967.532.5370.4468.212.50
251800-5180066.15866.86
351683-5168366.00866.66
452140-5214066.59267.28
552513-5251367.06967.74
654502-5450269.60970.27
20min157638-5763873.61471.062.7675.0872.482.73
255017-5501770.26771.70
354424-5442469.50970.90
456182-5618271.75573.18
553652-5365268.52369.94
656906-5690672.67974.11
30min159858-5985876.44974.412.2978.7476.622.28
258588-5858874.82777.04
356072-5607271.61473.77
457779-5777973.79476.02
557950-5795074.01376.19
659309-5930975.74877.99
45min163938-6393881.66078.882.2084.8081.922.20
261896-6189679.05282.10
359942-5994276.55779.51
461416-6141678.43981.48
560978-6097877.88080.88
662385-6238579.67782.76
60min163489-6348981.08780.181.6785.1384.101.63
264097-6409781.86385.79
361656-6165678.74682.55
461608-6160878.68582.60
563435-6343581.01884.88
662405-6240579.70283.67
极限163409-6340980.98578.982.5485.9383.792.48
264001-6400181.74186.58
360132-6013276.79981.48
460552-6055277.33682.12
561081-6108178.01182.78
661860-6186079.00683.86
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%
111.988417884288839708471684073842450.35
211.898388584293840890.35
单位质量响应值RSD%判断
7032.147072.250.41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%
10min129493-2949337.45139.905.1037.4539.915.10
233523-3352342.56842.57
332513-3251341.28641.29
431618-3161840.14940.15
531796-3179640.37540.38
629607-2960737.59637.60
15min159087-5908775.03074.971.6475.4575.421.62
258035-5803573.69474.17
359880-5988076.03776.50
457685-5768573.25073.70
559690-5969075.79676.24
659862-5986276.01476.43
20min164564-6456481.98580.931.6383.2382.201.62
263794-6379481.00782.30
364873-6487382.37883.68
462150-6215078.92080.18
564120-6412081.42182.71
662885-6288579.85381.12
30min170118-7011889.03885.773.1791.2087.953.11
268303-6830386.73388.92
368325-6832586.76188.98
463676-6367680.85882.99
567502-6750285.71687.91
667360-6736085.53687.69
45min171044-7104490.21489.392.5793.3692.522.53
271457-7145790.73893.89
372618-7261892.21295.40
469297-6929787.99591.03
570510-7051089.53692.68
667460-6746085.66388.76
60min173841-7384193.76590.882.2997.9295.012.25
271171-7117190.37594.54
373191-7319192.94097.15
469460-6946088.20292.22
570927-7092790.06594.21
670843-7084389.95894.01
极限170837-7083789.95190.573.4695.1595.703.34
272461-7246192.01397.18
374143-7414394.14999.39
467147-6714785.26590.26
570402-7040289.39894.54
672946-7294692.62997.68
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%
111.988435384134843638387584390842230.27
211.898501284506847590.43
单位质量响应值RSD%判断
7030.307128.600.99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%
10min154759-5475969.27068.141.5969.2768.141.59
252786-5278666.77466.77
353168-5316867.25767.26
453523-5352367.70667.71
554879-5487969.42169.42
654093-5409368.42768.43
15min159156-5915674.83273.822.8675.6074.582.85
256281-5628171.19571.94
357346-5734672.54273.29
457241-5724172.40973.16
560744-6074476.84177.61
659362-5936275.09275.85
20min162623-6262379.21776.682.3080.8278.262.29
259259-5925974.96276.50
359696-5969675.51577.07
459395-5939575.13476.69
561756-6175678.12179.75
660985-6098577.14578.74
30min166584-6658484.22880.013.7986.7182.443.73
260115-6011576.04578.41
361320-6132077.56979.96
462743-6274379.36981.76
563610-6361080.46682.96
665147-6514782.41084.86
45min168589-6858986.76483.002.6990.1886.322.66
263964-6396480.91484.12
366408-6640884.00587.26
463826-6382680.73984.01
565224-6522482.50885.89
665688-6568883.09586.46
60min168813-6881387.04882.462.9091.4386.702.84
264808-6480881.98186.09
363865-6386580.78984.98
464232-6423281.25385.42
565531-6553182.89687.20
663875-6387580.80185.09
极限167684-6768485.62083.081.6090.9788.241.62
265750-6575083.17388.19
365111-6511182.36587.45
464658-6465881.79286.87
565503-6550382.86188.09
665366-6536682.68787.88
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