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%
110.293902689389646038958393892713390491238985230.14
210.433981003399112139860620.18
单位质量响应值RSD%判断
378865.21382172.770.62数据可信
供试品溶液-2024091313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%
5min11295272-129527230.63630.6815.2030.6430.6815.20
21377046-137704632.57032.57
31245644-124564429.46229.46
41632233-163223338.60638.61
51176864-117686427.83627.84
61055337-105533724.96124.96
10min13023704-302370471.51867.7610.8571.5967.8210.85
23102876-310287673.39073.46
32786919-278691965.91765.98
43231456-323145676.43276.52
52631061-263106162.23162.29
62411944-241194457.04857.10
15min13665820-366582086.70585.247.1086.9385.467.11
23895006-389500692.12692.36
33644514-364451486.20186.41
43797710-379771089.82590.08
53423848-342384880.98281.18
63195943-319594375.59275.77
20min13913181-391318192.55692.423.8192.9892.833.84
24097078-409707896.90697.35
33937567-393756793.13393.54
44014744-401474494.95895.41
53799504-379950489.86790.25
63682347-368234787.09687.45
30min14085920-408592096.64297.831.4397.2798.441.46
24212745-421274599.641100.30
34145445-414544598.05098.66
44198590-419859099.30799.97
54079750-407975096.49697.08
64093648-409364896.82497.37
45min14160768-416076898.41299.991.0499.25100.821.05
24261258-4261258100.789101.67
34243363-4243363100.366101.19
44275009-4275009101.114102.00
54190879-419087999.12499.92
64234480-4234480100.155100.91
60min14190328-419032899.111100.700.93100.17101.750.93
24270789-4270789101.014102.12
34274785-4274785101.109102.16
44302516-4302516101.765102.88
54235363-4235363100.176101.19
64271098-4271098101.022102.00
极限14235057-4235057100.169101.320.79101.45102.600.78
24273163-4273163101.070102.40
34294983-4294983101.586102.86
44323492-4323492102.261103.60
54261584-4261584100.796102.03
64313893-4313893102.034103.24
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%
110.293918826392299339257673926162392793639243370.10
210.433969880397641339731460.12
单位质量响应值RSD%判断
381373.86380934.420.09数据可信
供试品溶液-2024091313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%
5min1943159-94315922.27029.5522.9922.2729.5522.98
21193295-119329528.17728.18
31322594-132259431.23031.23
4976303-97630323.05323.05
51347010-134701031.80631.81
61725967-172596740.75440.75
10min12544503-254450360.08266.7910.8960.1366.8610.89
22666536-266653662.96463.03
33143601-314360174.22874.30
42516713-251671359.42659.48
52860925-286092567.55467.62
63239946-323994676.50376.59
15min13381572-338157279.84784.715.5680.0384.925.58
23491484-349148482.44382.65
33726734-372673487.99888.23
43377097-337709779.74279.92
53689946-368994687.12987.35
63857052-385705291.07591.34
20min13832895-383289590.50493.142.6590.8693.542.69
23905446-390544692.21792.60
34011839-401183994.73095.16
43826880-382688090.36290.72
54012575-401257594.74795.16
64077128-407712896.27196.73
30min14170650-417065098.47998.870.6399.0499.480.67
24166596-416659698.38498.97
34199569-419956999.16299.80
44155601-415560198.12498.69
54218628-421862899.612100.24
64212465-421246599.467100.14
45min14281752-4281752101.103100.450.56101.88101.280.55
24226507-422650799.798100.61
34254433-4254433100.458101.32
44236351-4236351100.031100.81
54282287-4282287101.116101.96
64243313-4243313100.195101.09
60min14291218-4291218101.326100.700.55102.33101.750.55
24247048-4247048100.283101.31
34262199-4262199100.641101.73
44243937-4243937100.210101.21
54295955-4295955101.438102.51
64247205-4247205100.287101.41
极限14299810-4299810101.529100.750.53102.76102.030.52
24249820-4249820100.349101.60
34260835-4260835100.609101.92
44248237-4248237100.312101.54
54290459-4290459101.308102.60
64251937-4251937100.399101.74
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