布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
110.948545785219853398517585385853150.14
210.758475084983848660.20
单位质量响应值RSD%判断
7798.457894.510.87数据可信
供试品溶液-25061901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%
10min160084-6008468.57573.9115.0268.5873.9215.02
260356-6035668.88568.89
363531-6353172.50972.51
484417-8441796.34796.35
559815-5981568.26868.27
660368-6036868.89968.90
15min192605-92605105.69282.9013.70106.0783.3213.62
269505-6950579.32779.71
365011-6501174.19874.60
469641-6964179.48380.02
569357-6935779.15879.54
669712-6971279.56479.95
20min170923-7092380.94688.009.3381.9188.879.20
283309-8330995.08295.91
372784-7278483.07083.88
472872-7287283.17084.15
573990-7399084.44685.27
688756-88756101.299102.12
30min178379-7837989.45587.613.0890.8788.973.04
276791-7679187.64388.99
376109-7610986.86588.14
473172-7317283.51384.95
575986-7598686.72488.01
680136-8013691.46192.85
45min183918-8391895.77790.033.9997.6991.883.93
280309-8030991.65893.50
378053-7805389.08390.84
474736-7473685.29887.20
576919-7691987.78989.56
679358-7935890.57392.47
60min181763-8176393.31892.287.6795.7694.627.51
280385-8038591.74594.09
378202-7820289.25391.51
474006-7400684.46486.84
578446-7844689.53291.79
692305-92305105.349107.75
极限180188-8018891.52089.241.7394.4992.101.75
276873-7687387.73790.59
378386-7838689.46392.21
476752-7675287.59990.44
577709-7770988.69191.45
679219-7921990.41493.40
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
110.948525485216853348490984924851270.24
210.758491085162850360.21
单位质量响应值RSD%判断
7781.267910.331.17数据可信
供试品溶液-25062301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%
10min144101-4410150.33950.314.2050.3450.314.20
242284-4228448.26548.27
342287-4228748.26948.27
443949-4394950.16650.17
544511-4451150.80750.81
647319-4731954.01254.01
15min154062-5406261.70973.449.7361.9973.729.69
272505-7250582.76183.03
365963-6596375.29475.56
467268-6726876.78377.06
560962-6096269.58569.87
665299-6529974.53674.84
20min169436-6943679.25879.772.7479.8880.462.72
267814-6781477.40778.13
368411-6841178.08878.77
472655-7265582.93283.64
571771-7177181.92382.59
669233-6923379.02679.74
30min174405-7440584.93089.5623.8085.9990.6923.51
263091-6309172.01573.17
372781-7278183.07684.20
473737-7373784.16785.33
571125-7112581.18682.31
6115633-115633131.990133.14
45min173454-7345483.84486.201.4485.3887.831.46
276121-7612186.88988.45
375309-7530985.96287.54
476098-7609886.86288.50
576432-7643287.24488.82
675716-7571686.42688.31
60min177131-7713188.04186.961.5690.0489.071.47
277703-7770388.69490.74
376366-7636687.16889.23
476117-7611786.88489.00
574416-7441684.94287.00
675362-7536286.02288.39
极限172420-7242082.66485.822.1385.1588.412.10
275892-7589286.62789.16
375781-7578186.50089.04
477198-7719888.11890.72
574816-7481685.39987.93
674992-7499285.60088.44
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
110.948775487581878928772887890877690.15
210.758468884578846330.10
单位质量响应值RSD%判断
8022.767872.841.34数据可信
供试品溶液-25062302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%
10min160442-6044268.10872.1215.2068.1172.1215.20
259722-5972267.29667.30
359835-5983567.42467.42
458611-5861166.04466.04
561637-6163769.45469.45
683749-8374994.37194.37
15min167893-6789376.50477.911.7176.8878.311.76
268204-6820476.85477.23
369656-6965678.49078.86
468279-6827976.93977.31
570062-7006278.94879.33
670773-7077379.74980.27
20min171177-7117780.20480.973.0381.0181.813.07
272592-7259281.79982.60
369048-6904877.80578.62
470307-7030779.22480.02
572778-7277882.00882.83
675254-7525484.79885.77
30min174594-7459484.05586.917.1285.3088.207.04
275116-7511684.64385.90
374307-7430783.73184.97
473190-7319082.47283.71
587918-8791899.068100.35
677661-7766187.51188.95
45min175309-7530984.86086.561.5386.5888.331.60
276585-7658586.29888.02
376518-7651886.22387.93
476204-7620485.86987.56
577650-7765087.49889.33
678662-7866288.63890.56
60min176094-7609485.74599.8727.6087.93102.1226.96
278683-7868388.66290.87
3137968-137968155.466157.65
485682-8568296.54998.72
574885-7488584.38286.70
678459-7845988.41090.83
极限176375-7637586.06187.853.0988.7390.662.95
280384-8038490.57993.28
374541-7454183.99587.05
476923-7692386.67989.39
578991-7899189.00991.79
680561-8056190.77893.69
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