非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.961502640149295314962011493507149272214956050.28
210.081514003152425615191300.48
单位质量响应值RSD%判断
150161.14150707.340.26数据可信
供试品溶液-3786A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%
5min11081249-108124964.68857.7523.1664.6957.7523.15
2514417-51441730.77630.78
31092537-109253765.36365.36
41003418-100341860.03160.03
51072290-107229064.15264.15
61027668-102766861.48261.48
10min11435807-143580785.90083.234.8886.0483.364.91
21255046-125504675.08675.15
31415289-141528984.67284.82
41428115-142811585.44085.57
51399766-139976683.74483.89
61413367-141336784.55884.69
15min11557120-155712093.15891.631.4693.4991.941.49
21492838-149283889.31289.55
31538881-153888192.06792.40
41545502-154550292.46392.79
51522171-152217191.06791.40
61532769-153276991.70192.03
20min11605786-160578696.06995.670.6496.6196.190.68
21581222-158122294.60095.03
31594895-159489595.41895.96
41607442-160744296.16896.70
51607403-160740396.16696.70
61598366-159836695.62596.15
30min11633850-163385097.74897.120.8498.5097.850.83
21627843-162784397.38998.03
31626710-162671097.32198.07
41632454-163245497.66598.41
51597155-159715595.55396.30
61622559-162255997.07397.81
45min11645058-164505898.41997.521.2399.3998.461.21
21639129-163912998.06498.92
31645263-164526398.43199.40
41640145-164014598.12599.08
51597077-159707795.54896.51
61613475-161347596.52997.49
60min11640609-164060998.15397.351.0399.3498.511.00
21642084-164208498.24199.32
31629265-162926597.47498.66
41636358-163635897.89899.08
51600214-160021495.73696.91
61614319-161431996.58097.75
极限11641767-164176798.22297.691.3299.6399.071.30
21645493-164549398.44599.74
31629764-162976497.50498.91
41655802-165580299.062100.46
51593649-159364995.34396.73
61630971-163097197.57698.96
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.961493997149731615024171505555150455915007690.33
210.081547083154657415468280.03
单位质量响应值RSD%判断
150679.62153455.161.30数据可信
供试品溶液-3786A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%
5min11099287-109928765.06661.294.3865.0761.304.39
21065409-106540963.06163.06
31039335-103933561.51761.52
4986735-98673558.40458.40
51040926-104092661.61261.61
6981755-98175558.10958.11
10min11421162-142116284.11785.071.2884.2685.211.28
21452781-145278185.98986.13
31414762-141476283.73983.88
41444666-144466685.50985.64
51429521-142952184.61284.75
61461100-146110086.48186.61
15min11538207-153820791.04592.141.4691.3892.471.46
21587542-158754293.96594.30
31527603-152760390.41890.74
41564914-156491492.62692.95
51548110-154811091.63191.96
61573968-157396893.16293.48
20min11580604-158060493.55594.761.3694.0995.291.35
21633922-163392296.71197.25
31578653-157865393.43993.96
41612357-161235795.43495.96
51589672-158967294.09194.62
61610338-161033895.31595.84
30min11608172-160817295.18696.321.3995.9397.071.38
21654373-165437397.92198.68
31607415-160741595.14295.87
41651623-165162397.75898.50
51607718-160771895.16095.90
61635016-163501696.77597.52
45min11615903-161590395.64496.351.3196.6097.301.31
21664281-166428198.50799.48
31613302-161330295.49096.43
41632026-163202696.59897.55
51605321-160532195.01895.97
61635943-163594396.83097.79
60min11607111-160711195.12496.051.3496.2997.221.34
21656450-165645098.04499.24
31610979-161097995.35396.51
41626307-162630796.26097.43
51598075-159807594.58995.75
61637303-163730396.91198.08
极限11603715-160371594.92396.011.3096.3097.391.30
21655662-165566297.99799.41
31618164-161816495.77897.14
41619097-161909795.83397.22
51599268-159926894.65996.03
61636564-163656496.86798.25
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