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%
111.038454684320842968421784040842840.22
211.028393383792838620.12
单位质量响应值RSD%判断
7641.347609.980.30数据可信
供试品溶液-2821374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%
10min125172-2517229.56030.935.0129.5630.935.01
224735-2473529.04729.05
326333-2633330.92430.92
428259-2825933.18533.19
526166-2616630.72730.73
627356-2735632.12532.12
15min134346-3434640.33441.872.3440.5042.042.35
235691-3569141.91342.07
335786-3578642.02542.20
436452-3645242.80742.99
535095-3509541.21341.38
636541-3654142.91143.09
30min146454-4645454.55256.151.7754.9456.551.78
247387-4738755.64856.04
348167-4816756.56456.97
448088-4808856.47156.89
547805-4780556.13956.54
648973-4897357.51057.93
45min154037-5403763.45765.291.5164.1566.011.51
255614-5561465.30966.01
356166-5616665.95766.68
455392-5539265.04865.78
556226-5622666.02866.74
656160-5616065.95066.69
60min160245-6024570.74772.071.0471.7973.141.04
262064-6206472.88473.95
361445-6144572.15773.24
461134-6113471.79172.89
561502-6150272.22473.30
661813-6181372.58973.69
90min165525-6552576.94879.631.7378.3881.111.72
268812-6881280.80882.28
368180-6818080.06681.55
468068-6806879.93481.43
568430-6843080.35981.84
667845-6784579.67281.18
120min169956-6995682.15183.591.0284.0285.511.03
271863-7186384.39186.31
370651-7065182.96884.90
471552-7155284.02685.97
571559-7155984.03485.96
671495-7149583.95985.91
极限170849-7084983.20085.241.4085.5287.631.40
272681-7268185.35187.74
372217-7221784.80787.20
472952-7295285.67088.08
572910-7291085.62088.01
673907-7390786.79189.21
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%
111.038415883975840328388783823839750.16
211.028405284008840300.04
单位质量响应值RSD%判断
7613.337625.230.12数据可信
供试品溶液-25082601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%
10min122175-2217526.06221.7012.7226.0621.7012.72
218471-1847121.70921.71
318414-1841421.64221.64
419741-1974123.20223.20
516049-1604918.86318.86
615947-1594718.74318.74
15min129124-2912434.23036.965.0234.3737.085.00
231100-3110036.55236.67
332698-3269838.43038.55
433669-3366939.57139.70
530822-3082236.22536.33
631253-3125336.73236.84
30min135908-3590842.20343.6111.1742.5443.9311.10
236268-3626842.62642.95
339850-3985046.83647.17
441866-4186649.20549.55
538746-3874645.53945.84
629984-2998435.24035.55
45min137532-3753244.11247.904.8344.6848.474.82
240577-4057747.69148.25
342313-4231349.73150.32
442482-4248249.92950.55
542142-4214249.53050.09
639487-3948746.40946.91
60min142879-4287950.39652.083.8451.2152.913.83
243331-4333150.92751.75
346668-4666854.84955.72
446010-4601054.07654.98
542593-4259350.06050.89
644365-4436552.14352.90
90min149181-4918157.80356.294.1258.9057.414.07
247411-4741155.72356.83
349605-4960558.30159.48
448789-4878957.34258.54
544192-4419251.93953.05
648180-4818056.62657.68
120min149121-4912157.73260.953.4959.1562.383.47
251569-5156960.61062.03
352613-5261361.83763.34
454292-5429263.81065.33
550700-5070059.58860.99
652838-5283862.10163.47
极限152222-5222261.37760.824.3363.1162.594.24
253013-5301362.30764.06
354095-5409563.57865.42
451065-5106560.01761.89
547647-4764756.00057.73
652428-5242861.61963.33
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