非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
19.933247132598326893258532472325630.29
29.843254532786326660.53
单位质量响应值RSD%判断
3279.253319.720.87数据可信
供试品溶液-6010501批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19149-914924.87928.0813.7424.8828.0913.74
28280-828022.51622.52
310067-1006727.37627.38
411723-1172331.87931.88
510998-1099829.90729.91
611749-1174931.95031.95
10min118533-1853350.39849.105.1350.4449.155.14
216561-1656145.03545.07
317339-1733947.15147.20
419083-1908351.89351.95
518381-1838149.98450.03
618441-1844150.14750.20
15min122024-2202459.89159.502.0860.0259.632.09
221066-2106657.28657.40
321735-2173559.10559.23
422402-2240260.91961.06
522083-2208360.05160.18
621980-2198059.77159.91
20min124156-2415665.68865.241.9465.9165.461.94
223445-2344563.75563.96
323479-2347963.84764.07
424671-2467167.08967.33
524097-2409765.52865.76
624097-2409765.52865.76
30min125877-2587770.36872.021.7970.7072.361.80
226353-2635371.66371.98
326048-2604870.83371.16
426955-2695573.30073.65
526643-2664372.45272.79
627032-2703273.50973.85
45min128079-2807976.35677.211.4176.8177.671.41
228716-2871678.08978.52
327977-2797776.07976.53
428989-2898978.83179.31
528143-2814376.53176.99
628458-2845877.38777.86
60min129012-2901278.89480.101.1979.4780.681.19
229599-2959980.49081.05
329304-2930479.68880.26
430013-3001381.61682.22
529233-2923379.49580.09
629561-2956180.38780.98
极限130191-3019182.10082.611.3282.8183.331.32
230588-3058883.17983.88
329988-2998881.54882.25
431064-3106484.47485.22
530076-3007681.78782.51
630369-3036982.58483.31
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.952544272542822543362536742535062540450.17
210.052544802537832541320.20
单位质量响应值RSD%判断
25532.1625286.770.69数据可信
供试品溶液-6010501批-非布司他-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min167444-6744424.20027.6712.8424.2027.6612.85
263543-6354322.80022.80
375595-7559527.12427.12
486220-8622030.93730.94
583225-8322529.86229.86
686587-8658731.06831.07
10min1131631-13163147.23146.224.7047.2746.274.70
2118275-11827542.43842.48
3125209-12520944.92644.97
4134796-13479648.36648.42
5132080-13208047.39247.44
6130964-13096446.99147.04
15min1155317-15531755.73055.532.1155.8555.652.12
2148334-14833453.22453.33
3155431-15543155.77055.89
4157652-15765256.56756.70
5156148-15614856.02856.16
6155676-15567655.85855.99
20min1170370-17037061.13161.151.4661.3461.371.48
2166792-16679259.84760.04
3168744-16874460.54760.76
4174059-17405962.45462.68
5171257-17125761.44961.67
6171390-17139061.49761.72
30min1186290-18629066.84368.221.5067.1668.541.51
2189426-18942667.96868.27
3187842-18784267.40067.71
4193509-19350969.43369.76
5190682-19068268.41968.74
6193035-19303569.26369.59
45min1205382-20538273.69374.471.1074.1274.901.10
2209037-20903775.00575.42
3205366-20536673.68874.11
4211016-21101675.71576.16
5206244-20624474.00374.44
6208291-20829174.73775.18
60min1215811-21581177.43678.301.1077.9878.851.10
2219766-21976678.85579.39
3217172-21717277.92478.47
4221714-22171479.55480.13
5215678-21567877.38877.95
6219107-21910778.61879.18
极限1225222-22522280.81281.051.3681.4981.741.35
2228196-22819681.87982.55
3222539-22253979.85080.53
4230022-23002282.53583.24
5222466-22246679.82380.51
6226863-22686381.40182.10
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