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%
111.078500584961839258427284200844730.58
211.058500684731848680.23
单位质量响应值RSD%判断
7630.807680.360.46数据可信
供试品溶液-6022501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%
10min129090-2909034.02834.472.6834.0334.472.68
228781-2878133.66633.67
329417-2941734.41034.41
430585-3058535.77735.78
15min135223-3522341.20241.042.9741.5841.422.93
235360-3536041.36241.74
336110-3611042.24042.62
433633-3363339.34239.74
20min138319-3831944.82446.492.5045.6647.332.46
239985-3998546.77247.61
340041-4004146.83847.69
440626-4062647.52248.36
30min144375-4437551.90854.104.0253.2455.463.95
245473-4547353.19254.55
348745-4874557.01958.39
446400-4640054.27655.64
45min151891-5189160.69961.912.9162.6163.862.88
251709-5170960.48662.43
355055-5505564.40066.41
453043-5304362.04764.01
60min155053-5505364.39866.123.2866.9868.773.23
254804-5480464.10766.72
358183-5818368.05970.78
458073-5807367.93170.59
90min165680-6568076.82977.474.0280.1380.853.93
263559-6355974.34877.68
369906-6990681.77285.25
465759-6575976.92180.33
120min1-0.0000.00-4.154.242.70
2-0.0004.15
3-0.0004.39
4-0.0004.26
极限1-0.0000.00-4.154.242.70
2-0.0004.15
3-0.0004.39
4-0.0004.26
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%
111.078424084471846508447684192844060.23
211.058542385164852940.22
单位质量响应值RSD%判断
7624.757718.910.87数据可信
供试品溶液-6022501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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
15min1-0.0000.91200.010.000.92200.00
2-0.0000.00
33135-31353.6593.66
4-0.0000.00
20min1-0.0001.00200.000.001.01197.37
2-0.0000.00
3-0.0000.04
43429-34294.0034.00
30min13338-33383.8962.9467.123.902.9667.13
2-0.0000.00
33603-36034.2064.25
43125-31253.6483.69
45min13565-35654.1612.9766.864.203.0366.81
2-0.0000.00
33250-32503.7943.88
43377-33773.9424.03
60min13532-35324.1232.22116.054.212.30109.38
24071-40714.7524.75
3-0.0000.13
4-0.0000.13
90min1-0.0000.00-0.140.1137.28
2-0.0000.05
3-0.0000.13
4-0.0000.13
120min1-0.0000.00-0.140.1137.28
2-0.0000.05
3-0.0000.13
4-0.0000.13
极限1-0.0000.00-0.140.1137.28
2-0.0000.05
3-0.0000.13
4-0.0000.13
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%
111.078486184972845368478484464847230.26
211.058505084623848360.36
单位质量响应值RSD%判断
7653.397677.470.23数据可信
供试品溶液-6022501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min126754-2675431.25528.646.1831.2528.646.18
224014-2401428.05428.05
323901-2390127.92227.92
423407-2340727.34527.34
15min127795-2779532.47130.507.1232.8230.827.09
224264-2426428.34628.66
327614-2761432.26032.57
424751-2475128.91529.22
20min127870-2787032.55931.943.7733.2732.603.77
225910-2591030.26930.90
328266-2826633.02133.69
427319-2731931.91532.54
30min127273-2727331.86132.144.6832.9333.154.61
226035-2603530.41531.38
329162-2916234.06835.10
427583-2758332.22333.20
45min128950-2895033.82033.492.3435.2434.862.40
227733-2773332.39933.70
329289-2928934.21635.63
428701-2870133.53034.87
60min130493-3049335.62334.372.9837.4236.122.86
229164-2916434.07035.73
328403-2840333.18134.98
429638-2963834.62436.33
90min135618-3561841.61038.546.0943.8140.665.83
233495-3349539.13041.17
331483-3148336.78038.94
431365-3136536.64238.74
120min135052-3505240.94941.533.2943.6144.083.12
234125-3412539.86642.34
336517-3651742.66045.23
436493-3649342.63245.13
极限134591-3459140.41040.693.5043.5243.703.26
235663-3566341.66344.58
335853-3585341.88544.93
433202-3320238.78841.76
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