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%
1 11.058142181376815178142281352814180.08
2 11.088112981302812160.16
单位质量响应值RSD%判断
7368.147329.960.37数据可信
供试品溶液-2821374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%
10min141408-4140850.45751.174.1750.4651.174.17
240050-4005048.80248.80
342731-4273152.06952.07
442642-4264251.96151.96
540381-4038149.20649.21
644757-4475754.53854.54
15min171550-7155087.18686.402.6387.7586.962.62
267829-6782982.65283.19
370523-7052385.93586.51
473172-7317289.16289.74
572182-7218287.95688.50
670152-7015285.48286.09
20min173671-7367189.77088.802.6891.3090.322.66
271157-7115786.70788.17
370356-7035685.73187.26
475611-7561192.13493.70
574052-7405290.23591.76
672386-7238688.20589.76
30min176260-7626092.92593.521.5095.4596.041.51
275974-7597492.57795.00
376483-7648393.19795.68
478746-7874695.95598.55
575622-7562292.14894.67
677405-7740594.32096.86
45min177349-7734994.25294.131.5897.8197.691.56
276373-7637393.06396.52
377506-7750694.44497.97
478995-7899596.25899.92
577817-7781794.82398.37
675465-7546591.95795.54
60min177922-7792294.95095.041.5299.5699.641.50
276988-7698893.81298.30
378837-7883796.065100.64
479908-7990897.370102.10
577442-7744294.36698.97
676879-7687993.68098.29
极限175383-7538391.85794.641.5097.52100.291.43
277802-7780294.804100.33
378443-7844395.585101.22
478318-7831895.433101.24
578365-7836595.490101.14
677674-7767494.648100.29
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%
1 11.058092081351813768133981082812140.25
2 11.088111181064810880.05
单位质量响应值RSD%判断
7349.687318.410.31数据可信
供试品溶液-2810778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%
10min141697-4169750.91353.878.5050.9153.888.50
240057-4005748.91148.91
347078-4707857.48357.48
442215-4221551.54551.55
550064-5006461.12961.13
643626-4362653.26853.27
15min170033-7003385.51286.191.5486.0886.791.58
270119-7011985.61786.16
371110-7111086.82787.47
469616-6961685.00385.58
572556-7255688.59389.27
670114-7011485.61186.20
20min173227-7322789.41288.251.7790.9389.801.75
272493-7249388.51690.01
371038-7103886.73988.34
472275-7227588.24989.77
573976-7397690.32691.99
670628-7062886.23887.78
30min174312-7431290.73791.151.2493.2593.691.27
274942-7494291.50693.98
374820-7482091.35793.92
474200-7420090.60093.10
576191-7619193.03195.70
673451-7345189.68592.19
45min176307-7630793.17391.991.6496.6995.541.61
275656-7565692.37895.87
374927-7492791.48895.07
475876-7587692.64696.15
576224-7622493.07196.77
673038-7303889.18192.68
60min177275-7727594.35593.531.0398.9198.101.05
276798-7679893.77298.29
376197-7619793.03897.64
476039-7603992.84597.38
577678-7767894.84799.58
675624-7562492.33996.83
极限180514-8051498.30995.372.69103.91100.982.59
277271-7727194.35099.91
375591-7559192.29897.93
477097-7709794.13799.70
580842-8084298.710104.50
677313-7731394.40199.92
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%
1 11.058145881392813858131981217813540.12
2 11.088135781459814080.09
单位质量响应值RSD%判断
7362.357347.290.15数据可信
供试品溶液-2821374批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min14441-44415.4075.437.595.415.437.55
23949-39494.8084.81
34410-44105.3695.37
45013-50136.1046.10
54506-45065.4865.49
64448-44485.4165.42
15min16230-62307.5857.868.967.657.928.89
26080-60807.4037.46
37515-75159.1509.21
46581-65818.0138.08
55871-58717.1487.21
66465-64657.8727.93
20min17801-78019.4989.095.749.649.245.71
26789-67898.2668.40
37270-72708.8529.01
47885-78859.6019.76
57270-72708.8528.99
67773-77739.4649.61
30min18729-872910.62811.5811.2210.8811.8311.03
28962-896210.91211.14
39199-919911.20011.46
411482-1148213.98014.24
59962-996212.12912.37
68739-873910.64010.89
45min110066-1006612.25612.653.9312.6213.023.88
210068-1006812.25812.61
311054-1105413.45913.84
410386-1038612.64613.06
510680-1068013.00413.38
610075-1007512.26712.64
60min111376-1137613.85114.807.5114.3615.327.25
211748-1174814.30414.79
312264-1226414.93215.47
411936-1193614.53315.09
511672-1167214.21114.73
613915-1391516.94217.45
极限113414-1341416.33215.873.0316.9916.562.95
212759-1275915.53516.18
313444-1344416.36917.07
413311-1331116.20716.93
512681-1268115.44016.12
612603-1260315.34516.04
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