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%
110.031536793153625415325931529282152426415318370.35
210.201550114155023415501740.01
单位质量响应值RSD%判断
152725.52151977.840.35数据可信
供试品溶液-3780C批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118330-183301.0830.9524.681.080.9524.49
215651-156510.9250.92
313018-130180.7690.77
416572-165720.9790.98
510822-108220.6390.64
622086-220861.3051.30
10min126051-260511.5391.4510.051.541.4510.00
222959-229591.3561.36
323627-236271.3961.40
423835-238351.4081.41
521913-219131.2941.30
628692-286921.6951.70
15min129262-292621.7291.7911.621.731.7911.76
225688-256881.5171.52
333430-334301.9751.98
432329-323291.9101.92
526893-268931.5891.59
634024-340242.0102.02
20min124790-247901.4641.738.161.471.748.20
228382-283821.6771.69
331084-310841.8361.85
430853-308531.8231.83
530432-304321.7981.81
629847-298471.7631.77
30min129176-291761.7241.724.551.741.744.37
229439-294391.7391.75
329760-297601.7581.77
430453-304531.7991.81
529609-296091.7491.76
626605-266051.5721.59
45min128737-287371.6981.743.851.711.764.01
228839-288391.7041.72
329346-293461.7341.75
428537-285371.6861.70
529726-297261.7561.77
631599-315991.8671.89
60min128506-285061.6841.784.911.701.804.79
231021-310211.8331.85
330989-309891.8311.85
432027-320271.8921.91
530074-300741.7771.80
628347-283471.6751.70
极限129793-297931.7601.792.271.781.822.43
229296-292961.7311.75
331025-310251.8331.86
431030-310301.8331.86
530464-304641.8001.82
630467-304671.8001.83
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%
110.031507511150681115069811505888150571815065820.06
210.201558048155829115581700.02
单位质量响应值RSD%判断
150207.58152761.761.20数据可信
供试品溶液-3780C批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18436-84360.5010.9441.880.500.9441.83
226774-267741.5911.59
320765-207651.2341.23
412954-129540.7700.77
513559-135590.8060.81
612820-128200.7620.76
10min120361-203611.2101.4817.611.211.4817.77
223615-236151.4031.41
332878-328781.9531.96
422237-222371.3211.32
523945-239451.4231.42
626483-264831.5741.58
15min125388-253881.5081.7013.791.511.7013.87
231056-310561.8451.85
326862-268621.5961.60
426398-263981.5681.57
535579-355792.1142.12
626415-264151.5691.57
20min129137-291371.7311.6810.141.741.6810.10
223234-232341.3801.39
329774-297741.7691.78
429724-297241.7661.77
530901-309011.8361.85
626419-264191.5701.58
30min129430-294301.7491.724.571.761.734.58
229024-290241.7241.74
330058-300581.7861.80
428657-286571.7031.71
529797-297971.7701.78
626405-264051.5691.58
45min129883-298831.7761.7711.791.791.7911.82
236192-361922.1502.17
328780-287801.7101.73
430272-302721.7991.81
528058-280581.6671.68
625715-257151.5281.54
60min129438-294381.7491.814.691.771.834.75
230263-302631.7981.82
332263-322631.9171.94
430462-304621.8101.83
531626-316261.8791.90
628346-283461.6841.70
极限130997-309971.8421.786.801.861.806.66
231863-318631.8931.92
329158-291581.7321.76
429688-296881.7641.79
531365-313651.8641.89
626320-263201.5641.59
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