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%
19.961969618197807519626271948851195163319621610.63
210.082027388202569020265390.06
单位质量响应值RSD%判断
197004.12201045.541.44数据可信
供试品溶液-3780C批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11181011-118101153.41149.9421.8553.4149.9421.85
21221223-122122355.23055.23
31180450-118045053.38653.39
41290646-129064658.37058.37
5624365-62436528.23728.24
61127558-112755850.99450.99
10min11806127-180612781.68279.156.1881.8079.266.19
21787408-178740880.83680.96
31822566-182256682.42682.54
41783529-178352980.66080.79
51533134-153313469.33669.40
61768231-176823179.96980.08
15min11986415-198641589.83688.131.7490.1488.421.77
21959038-195903888.59888.90
31974328-197432889.28989.59
41943481-194348187.89488.20
51890437-189043785.49585.71
61939051-193905187.69487.98
20min12057049-205704993.03091.890.8693.5392.370.88
22035152-203515292.04092.54
32046451-204645192.55193.05
42017250-201725091.23091.73
52014485-201448591.10591.51
62020416-202041691.37491.86
30min12125448-212544896.12495.520.7396.8396.200.71
22112125-211212595.52196.22
32120456-212045695.89896.60
42093882-209388294.69695.40
52127174-212717496.20296.81
62093397-209339794.67495.36
45min12141711-214171196.85996.750.7797.7897.650.73
22145690-214569097.03997.96
32132161-213216196.42797.35
42123528-212352896.03796.95
52167577-216757798.02998.85
62125660-212566096.13397.03
60min12139581-213958196.76397.682.2897.9098.792.26
22148128-214812897.14998.28
32255082-2255082101.986103.12
42123328-212332896.02897.16
52166554-216655497.98399.02
62126356-212635696.16597.28
极限12127151-212715196.20196.590.9397.5597.920.89
22159504-215950497.66499.01
32129871-212987196.32497.68
42118548-211854895.81297.16
52161414-216141497.75099.01
62118167-211816795.79497.12
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%
19.961960550194818219559831953856195186119540860.24
210.081962517196571919641180.12
单位质量响应值RSD%判断
196193.37194852.980.49数据可信
供试品溶液-3780C批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11155977-115597753.21146.9827.0353.2146.9827.03
21063970-106397048.97548.98
31316936-131693660.62060.62
4501293-50129323.07523.07
51014314-101431446.69046.69
61071351-107135149.31549.32
10min11752189-175218980.65576.149.3080.7776.249.33
21612217-161221774.21274.32
31749075-174907580.51180.65
41359333-135933362.57162.62
51744671-174467180.30980.41
61707359-170735978.59178.70
15min11915616-191561688.17886.013.8888.4786.283.92
21830342-183034284.25284.53
31906097-190609787.73988.05
41738895-173889580.04380.23
51931517-193151788.90989.19
61888109-188810986.91187.20
20min12003097-200309792.20491.041.8292.7091.501.86
21963720-196372090.39290.85
31984653-198465391.35591.86
41922540-192254088.49688.86
52026682-202668293.29093.77
61965601-196560190.47890.96
30min12082165-208216595.84495.300.9896.5495.960.98
22062796-206279694.95295.61
32062178-206217894.92495.64
42065160-206516095.06195.63
52103784-210378496.83997.53
62045489-204548994.15694.83
45min12108187-210818797.04296.890.9697.9597.770.96
22092801-209280196.33397.21
32101188-210118896.72097.64
42105902-210590296.93797.71
52140565-214056598.53299.43
62080913-208091395.78696.67
60min12116852-211685297.44197.791.2498.5798.881.24
22123222-212322297.73498.82
32145444-214544498.75799.89
42112813-211281397.25598.25
52161451-216145199.494100.61
62086583-208658396.04797.15
极限12119038-211903897.54197.200.9698.8898.510.96
22095359-209535996.45197.76
32112693-211269397.24998.61
42110871-211087197.16598.37
52144736-214473698.724100.07
62087052-208705296.06997.38
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