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%
110.037984580561797308020380865802410.60
210.047993879457796980.43
单位质量响应值RSD%判断
8000.107938.050.56数据可信
供试品溶液-25090501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%
10min129060-2906032.65645.0915.1232.6645.0815.12
238054-3805442.76342.76
340494-4049445.50545.50
443311-4331148.67048.67
545702-4570251.35751.36
644103-4410349.56049.56
15min148190-4819054.15354.946.7854.5255.446.79
243987-4398749.43049.90
348007-4800753.94754.45
447898-4789853.82554.37
552116-5211658.56559.14
653147-5314759.72360.27
30min155696-5569662.58863.553.6163.5564.673.58
254478-5447861.21962.24
358268-5826865.47866.58
459336-5933666.67867.82
557161-5716164.23465.46
654401-5440161.13262.35
45min160324-6032467.78866.987.2769.4568.797.16
251132-5113257.45959.16
362390-6239070.11071.94
462742-6274270.50572.39
559453-5945366.80968.74
661567-6156769.18571.08
60min155367-5536762.21867.485.6864.6370.045.62
259210-5921066.53668.88
357103-5710364.16966.78
461482-6148269.09071.75
563760-6376071.64974.33
663370-6337071.21173.87
90min168199-6819976.63876.932.8979.7480.242.93
265534-6553473.64376.73
367667-6766776.04079.36
470866-7086679.63583.07
570506-7050679.23082.70
667980-6798076.39279.85
120min168388-6838876.85077.082.6780.8181.252.52
267957-6795776.36680.27
372149-7214981.07685.25
466834-6683475.10479.42
567849-6784976.24480.60
668406-6840676.87081.17
极限170318-7031879.01976.824.6283.8381.844.34
265476-6547673.57878.33
370897-7089779.67084.74
469385-6938577.97083.12
563397-6339771.24176.44
670688-7068879.43584.59
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%
110.037944079786799847972979575797030.27
210.047987479763798180.10
单位质量响应值RSD%判断
7946.467950.000.04数据可信
供试品溶液-25090501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%
10min12874-28743.2382.0631.933.242.0631.91
21170-11701.3181.32
31739-17391.9591.96
41427-14271.6081.61
51837-18372.0702.07
61938-19382.1832.18
15min11261-12611.4211.8623.991.461.8823.52
21984-19842.2352.25
31588-15881.7891.81
41339-13391.5091.53
52267-22672.5542.58
61454-14541.6381.66
30min11339-13391.5091.6412.871.561.6812.41
21801-18012.0292.07
31489-14891.6781.72
41416-14161.5951.63
51399-13991.5761.63
61267-12671.4271.47
45min12028-20282.2852.3031.342.352.3630.41
21879-18792.1172.18
31327-13271.4951.56
43032-30323.4163.47
52507-25072.8252.89
61482-14821.6701.73
60min12719-27193.0633.4719.993.163.5619.48
23075-30753.4643.55
32206-22062.4852.56
43113-31133.5073.60
53305-33053.7243.82
64052-40524.5654.64
90min14149-41494.6754.4526.524.804.5825.83
22973-29733.3503.47
33807-38074.2894.39
45922-59226.6726.80
53586-35864.0404.18
63274-32743.6893.82
120min13658-36584.1213.5215.684.303.7015.01
22523-25232.8433.00
32881-28813.2463.40
42711-27113.0543.26
53301-33013.7193.91
63664-36644.1284.30
极限12026-20262.2833.8424.482.514.0623.21
23842-38424.3294.52
32951-29513.3253.51
44207-42074.7404.98
53307-33073.7263.95
64136-41364.6604.87
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