布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.049294193122926499296893207929770.23
211.009304192568928040.37
单位质量响应值RSD%判断
8421.838436.730.13数据可信
供试品溶液-25042201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%
5min146498-4649849.39850.375.9449.4050.375.94
248100-4810051.10051.10
350320-5032053.45853.46
446911-4691149.83749.84
542637-4263745.29645.30
650011-5001153.13053.13
10min167285-6728571.48269.892.9871.5669.972.98
262823-6282366.74166.83
365613-6561369.70569.79
466748-6674870.91170.99
564262-6426268.27068.35
667994-6799472.23572.32
15min172288-7228876.79774.193.0677.0074.393.05
271521-7152175.98276.18
370080-7008074.45174.66
468524-6852472.79873.00
566385-6638570.52570.71
670226-7022674.60674.81
20min172419-7241976.93676.185.9177.2776.505.88
276656-7665681.43781.76
374049-7404978.66779.00
471170-7117075.60975.93
571903-7190376.38876.69
664045-6404568.03968.37
30min180658-8065885.68981.393.7286.1581.843.71
279161-7916184.09884.56
376207-7620780.96081.42
474743-7474379.40579.85
572936-7293677.48577.92
675987-7598780.72681.17
45min184582-8458289.85782.807.3790.4683.397.34
282613-8261387.76688.36
378767-7876783.68084.28
478352-7835283.23983.82
568562-6856272.83873.40
674766-7476679.42980.01
60min186742-8674292.15287.033.4692.9087.763.46
282063-8206387.18187.93
382307-8230787.44088.18
481120-8112086.17986.90
577963-7796382.82683.51
681333-8133386.40687.12
极限184640-8464089.91984.915.9290.8285.785.88
286599-8659992.00092.89
378509-7850983.40684.29
475034-7503479.71480.58
579147-7914784.08384.91
675613-7561380.32981.19
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.049309393180935329339193463933320.21
211.009265092912927810.20
单位质量响应值RSD%判断
8453.998434.640.17数据可信
供试品溶液-25042202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%
5min148471-4847151.40248.6012.6051.4048.6012.60
253688-5368856.93556.93
347983-4798350.88550.88
446192-4619248.98648.99
541332-4133243.83243.83
637294-3729439.54939.55
10min168323-6832372.45564.2013.9272.5464.2813.92
270541-7054174.80774.90
361574-6157465.29865.38
458949-5894962.51462.60
556551-5655159.97160.04
647312-4731250.17350.24
15min170601-7060174.87167.7513.8375.0867.9413.82
276502-7650281.12981.35
363103-6310366.91967.11
461829-6182965.56865.75
560408-6040864.06164.23
650898-5089853.97654.13
20min179037-7903783.81773.6215.5384.1573.9315.53
282624-8262487.62187.98
372149-7214976.51276.82
467147-6714771.20871.50
561772-6177265.50865.79
653823-5382357.07857.32
30min185386-8538690.55077.3917.8991.0277.8117.86
288291-8829193.63194.13
375597-7559780.16980.60
469732-6973273.94974.36
565686-6568669.65970.05
653170-5317056.38656.72
45min190264-9026495.72378.9820.0796.3479.5320.03
290258-9025895.71796.37
378372-7837283.11283.68
467937-6793772.04672.58
568409-6840972.54673.05
651592-5159254.71255.14
60min193530-9353099.18781.4321.8899.9782.1121.83
296505-96505102.341103.16
382389-8238987.37288.08
470275-7027574.52575.18
563149-6314966.96867.59
654845-5484558.16258.68
极限193338-9333898.98384.8220.8699.9385.6420.82
2101984-101984108.152109.14
383811-8381188.88089.73
475164-7516479.71080.49
569893-6989374.12074.86
655705-5570559.07459.69
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