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%
19.961975956197224119748661978081198040019763090.16
210.082007975200883620084060.04
单位质量响应值RSD%判断
198424.60199246.630.30数据可信
供试品溶液-3785B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%
5min1770510-77051034.87633.7033.9334.8833.7033.93
21006414-100641445.55445.55
3526602-52660223.83623.84
4546582-54658224.74024.74
51087080-108708049.20549.21
6530413-53041324.00824.01
10min11599679-159967972.40774.119.4072.4874.189.41
21782859-178285980.69980.80
31681800-168180076.12576.18
41557015-155701570.47670.53
51806782-180678281.78281.89
61395509-139550963.16663.22
15min11864552-186455284.39784.852.4484.6385.092.47
21914957-191495786.67886.96
31880725-188072585.12985.35
41828650-182865082.77182.98
51935971-193597187.62987.92
61822271-182227182.48382.68
20min11985121-198512189.85490.431.9890.2890.862.00
21999448-199944890.50290.98
31985229-198522989.85990.27
41946267-194626788.09588.49
52066779-206677993.55094.04
62004228-200422890.71991.10
30min12094448-209444894.80293.790.7895.4394.420.80
22084895-208489594.37095.04
32067475-206747593.58294.19
42050204-205020492.80093.39
52074531-207453193.90194.59
62061461-206146193.30993.89
45min12132483-213248396.52495.971.8897.3696.801.83
22121500-212150096.02796.91
32090359-209035994.61795.44
42103328-210332895.20496.00
52082051-208205194.24195.14
62191460-219146099.19499.98
60min12082289-208228994.25294.580.7295.3095.630.72
22086980-208698094.46495.56
32074319-207431993.89194.92
42078449-207844994.07895.09
52103816-210381695.22796.34
62111726-211172695.58596.59
极限12114790-211479095.72395.140.4996.9896.400.46
22091071-209107194.65095.96
32091746-209174694.68095.92
42112144-211214495.60396.82
52097217-209721794.92896.25
62103959-210395995.23396.45
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%
19.961979731197682219777851976795197588019774030.08
210.082035277203402120346490.05
单位质量响应值RSD%判断
198534.44201850.101.18数据可信
供试品溶液-3785B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%
5min1525487-52548723.62635.9129.2823.6335.9129.27
21080390-108039048.57448.57
3544952-54495224.50124.50
4927502-92750241.70041.70
5982344-98234444.16644.17
6731228-73122832.87632.88
10min11389779-138977962.48470.368.6562.5470.448.66
21779034-177903479.98580.09
31495468-149546867.23667.29
41613384-161338472.53872.63
51494678-149467867.20167.30
61617909-161790972.74172.81
15min11802175-180217581.02683.172.6581.2283.402.68
21923488-192348886.48086.77
31810715-181071581.41081.61
41816028-181602881.64881.90
51889516-188951684.95285.20
61856782-185678283.48183.72
20min11975286-197528688.80988.921.0389.1889.341.06
22009296-200929690.33890.82
31950237-195023787.68288.07
41964708-196470888.33388.77
51989423-198942389.44489.88
61977034-197703488.88789.31
30min12082489-208248993.62892.581.3094.2093.201.28
22059814-205981492.60993.29
32042959-204295991.85192.43
42045663-204566391.97392.60
52026050-202605091.09191.73
62097397-209739794.29994.92
45min12109985-210998594.86594.770.5595.6495.590.52
22091963-209196394.05494.94
32112544-211254494.98095.76
42096067-209606794.23995.07
52115726-211572695.12395.96
62120792-212079295.35196.18
60min12104950-210495094.63893.900.5195.6394.940.50
22091541-209154194.03595.13
32075745-207574593.32594.32
42091085-209108594.01595.06
52089818-208981893.95895.01
62078557-207855793.45294.49
极限12090555-209055593.99194.361.1895.1995.611.15
22079470-207947093.49394.80
32110474-211047494.88796.09
42066196-206619692.89694.15
52113230-211323095.01196.27
62132970-213297095.89897.14
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