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101278-202003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%
110.041913286191327419123441911348191113119122770.06
210.171932273193217419322240.01
单位质量响应值RSD%判断
190465.84189992.530.18数据可信
供试品溶液-2024112321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%
5min11086696-108669651.41344.3024.1251.4144.3024.12
2852320-85232040.32440.32
3783297-78329737.05937.06
4863118-86311840.83540.84
51319553-131955362.43062.43
6713627-71362733.76333.76
10min11799745-179974585.14982.484.6385.2682.584.65
21757664-175766483.15883.25
31737013-173701382.18182.26
41668599-166859978.94479.03
51856618-185661887.83987.98
61640025-164002577.59277.67
15min11970625-197062593.23392.291.6993.5492.581.72
21945649-194564992.05192.33
31947760-194776092.15192.42
41934295-193429591.51491.78
52001492-200149294.69395.03
61904707-190470790.11490.36
20min12032618-203261896.16695.790.9696.6896.280.99
22012961-201296195.23695.72
32025930-202593095.85096.32
42023572-202357295.73896.21
52055471-205547197.24797.79
61997954-199795494.52694.97
30min12077164-207716498.27498.230.7299.0098.930.75
22064210-206421097.66198.35
32076940-207694098.26398.95
42078115-207811598.31999.00
52101836-210183699.441100.20
62059111-205911197.41998.08
45min12093483-209348399.04699.260.6999.99100.180.71
22088745-208874598.82299.73
32103604-210360499.525100.43
42101864-210186499.442100.34
52121116-2121116100.353101.33
62079456-207945698.38299.26
60min12103624-210362499.52599.740.69100.69100.880.71
22095674-209567499.149100.28
32120825-2120825100.339101.46
42111778-211177899.911101.03
52126972-2126972100.630101.83
62089810-208981098.87299.96
极限12101996-210199699.44899.840.74100.83101.200.75
22098131-209813199.266100.61
32126961-2126961100.630101.97
42115629-2115629100.093101.44
52127983-2127983100.678102.11
62091101-209110198.933100.25
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101278-202003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%
110.041914733191674519172631916554191461919159830.07
210.171949883194887619493800.04
单位质量响应值RSD%判断
190834.96191679.450.32数据可信
供试品溶液-2024112421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%
5min1856157-85615740.28845.3515.3340.2945.3515.33
2732231-73223134.45734.46
3950772-95077244.74144.74
41066437-106643750.18450.18
51120942-112094252.74852.75
61056018-105601849.69349.69
10min11679675-167967579.04181.154.9379.1381.254.95
21572762-157276274.01074.09
31741462-174146281.94882.05
41792215-179221584.33784.45
51777441-177744183.64283.76
61782842-178284283.89684.01
15min11933787-193378790.99990.991.1991.2691.271.21
21892846-189284689.07289.31
31925650-192565090.61690.90
41953913-195391391.94692.24
51940368-194036891.30891.61
61954954-195495491.99592.29
20min12022473-202247395.17294.830.6295.6495.310.63
22000860-200086094.15594.59
32002187-200218794.21794.70
42027597-202759795.41395.92
52010286-201028694.59995.10
62027439-202743995.40695.91
30min12080807-208080797.91797.230.6898.6097.920.68
22062776-206277697.06997.72
32045369-204536996.25096.94
42070397-207039797.42798.14
52056773-205677396.78697.50
62080998-208099897.92698.64
45min12105461-210546199.07798.390.6499.9799.300.63
22091791-209179198.43499.30
32070203-207020397.41898.32
42093758-209375898.52799.46
52081694-208169497.95998.89
62102626-210262698.94499.87
60min12113300-211330099.44698.730.66100.5699.860.64
22103263-210326398.974100.06
32075866-207586697.68598.81
42099995-209999598.82099.97
52088855-208885598.29699.44
62107578-210757899.177100.33
极限12116292-211629299.58798.950.56100.92100.300.55
22105319-210531999.071100.37
32085688-208568898.14799.49
42102356-210235698.931100.30
52093689-209368998.52399.89
62113485-211348599.455100.83
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101278-202003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%
110.041922219192301519230241923023192165419225870.04
210.171961507196144819614780.01
单位质量响应值RSD%判断
191492.73192869.030.51数据可信
供试品溶液-2024112422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%
5min1585642-58564227.42641.0622.9227.4341.0622.91
2879472-87947241.18741.19
31145564-114556453.64853.65
4716974-71697433.57733.58
51006213-100621347.12247.12
6926169-92616943.37443.37
10min11506531-150653170.55380.367.3370.6180.457.35
21784966-178496683.59383.68
31822853-182285385.36785.49
41623720-162372076.04176.12
51815131-181513185.00585.11
61742183-174218381.58981.69
15min11907763-190776389.34391.751.8089.5692.021.83
21964929-196492992.02192.30
31997696-199769693.55593.86
41948554-194855491.25491.50
51997475-199747593.54593.84
61938070-193807090.76391.04
20min12041047-204104795.58595.771.0496.0096.251.04
22031358-203135895.13295.61
32059960-205996096.47196.99
42061688-206168896.55297.00
52064822-206482296.69997.20
62011448-201144894.19994.68
30min12118441-211844199.21098.501.3199.8499.191.29
22081188-208118897.46598.16
32115866-211586699.08999.82
42128157-212815799.665100.33
52118394-211839499.20899.92
62058171-205817196.38797.08
45min12148986-2148986100.64099.751.29101.49100.651.27
22110632-211063298.84499.75
32142505-2142505100.337101.29
42157691-2157691101.048101.93
52134878-213487899.980100.92
62084665-208466597.62898.53
60min12152043-2152043100.783100.021.31101.86101.151.29
22117952-211795299.187100.32
32145796-2145796100.491101.67
42166670-2166670101.468102.58
52143066-2143066100.363101.52
62089123-208912397.83798.96
极限12157725-2157725101.049100.031.42102.35101.381.40
22111239-211123998.872100.22
32148640-2148640100.624102.02
42168858-2168858101.571102.90
52140501-2140501100.243101.62
62088945-208894597.82899.17
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