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%
19.651828206183467518330371829916182728318306230.18
29.711864079186260818633440.06
单位质量响应值RSD%判断
189701.87191899.490.82数据可信
供试品溶液-2024112521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%
5min11066490-106649050.30847.7314.1050.3147.7314.10
2751750-75175035.46135.46
31143774-114377453.95353.95
41062567-106256750.12350.12
5949718-94971844.79944.80
61097231-109723151.75851.76
10min11795011-179501184.67386.063.3584.7886.173.36
21788070-178807084.34584.42
31889983-188998389.15389.27
41883148-188314888.83088.94
51736133-173613381.89582.00
61854473-185447387.47887.59
15min12034619-203461995.97595.413.5096.2895.713.51
22011133-201113394.86895.13
32064912-206491297.40497.72
42080012-208001298.11798.43
51886902-188690289.00789.29
62058023-205802397.07997.39
20min12081772-208177298.20098.183.6698.7198.683.66
22082645-208264598.24198.72
32110660-211066099.562100.10
42137727-2137727100.839101.37
51934986-193498691.27691.75
62139826-2139826100.938101.46
30min12103797-210379799.23999.133.2899.9799.863.28
22128012-2128012100.381101.08
32136441-2136441100.779101.53
42148302-2148302101.338102.09
51964115-196411592.65093.33
62128035-2128035100.382101.13
45min12110565-211056599.55899.793.32100.51100.743.33
22127581-2127581100.361101.28
32156611-2156611101.730102.71
42170901-2170901102.404103.38
51979045-197904593.35494.24
62148762-2148762101.360102.33
60min12130638-2130638100.505100.063.28101.68101.233.28
22132869-2132869100.610101.75
32163778-2163778102.068103.27
42160517-2160517101.914103.12
51982615-198261593.52294.62
62156914-2156914101.744102.94
极限12134616-2134616100.692100.133.47102.09101.523.47
22167522-2167522102.245103.61
32166648-2166648102.203103.64
42152381-2152381101.530102.96
51975055-197505593.16694.47
62140106-2140106100.951102.38
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%
19.651837012184111318355391837397183639618374910.12
29.711881345188275118820480.06
单位质量响应值RSD%判断
190413.58193825.751.26数据可信
供试品溶液-b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%
5min11197435-119743556.09950.5211.9756.1050.5211.97
21068264-106826450.04850.05
31141073-114107353.45953.46
41187755-118775555.64655.65
51019374-101937447.75747.76
6855800-85580040.09440.09
10min11858525-185852587.07183.733.6587.2083.843.66
21772431-177243183.03883.15
31714557-171455780.32680.44
41867452-186745287.48987.61
51788276-178827683.78083.89
61722313-172231380.69080.78
15min12034762-203476295.32892.802.8395.6593.102.83
21971980-197198092.38692.68
31885044-188504488.31388.61
42024626-202462694.85395.17
52012197-201219794.27094.56
61955830-195583091.63091.90
20min12068650-206865096.91595.891.0397.4596.401.04
22031913-203191395.19495.70
32066408-206640896.81097.30
42056952-205695296.36796.90
52041363-204136395.63796.14
62015729-201572994.43694.91
30min12113626-211362699.02297.232.2499.7797.942.24
22084779-208477997.67198.38
31997681-199768193.59094.30
42109215-210921598.81699.56
52104728-210472898.60599.32
62041786-204178695.65796.34
45min12115342-211534299.10397.392.37100.0798.332.37
22081597-208159797.52298.45
31988155-198815593.14494.06
42127142-212714299.656100.62
52070059-207005996.98197.91
62090826-209082697.95498.85
60min12123598-212359899.49098.401.99100.6899.561.99
22099747-209974798.37299.52
32020066-202006694.63995.76
42138402-2138402100.183101.37
52114544-211454499.065100.21
62106252-210625298.67799.79
极限12120942-212094299.36597.522.21100.7798.892.21
22074613-207461397.19598.56
31999858-199985893.69295.03
42127096-212709699.653101.06
52073405-207340597.13898.51
62093414-209341498.07599.41
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%
19.651846883184190718454071844424184176718440780.13
29.711886983189120218890920.16
单位质量响应值RSD%判断
191096.17194551.181.27数据可信
供试品溶液-2024112621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%
5min11057407-105740749.35850.7211.7849.3650.7211.78
21217058-121705856.81056.81
31236776-123677657.73157.73
41107182-110718251.68251.68
5994545-99454546.42446.42
6906273-90627342.30342.30
10min11806446-180644684.32283.431.8684.4383.551.86
21762002-176200282.24882.37
31806053-180605384.30484.43
41832628-183262885.54485.66
51743903-174390381.40381.51
61773437-177343782.78182.88
15min11954675-195467591.24191.652.5691.5491.952.55
21884066-188406687.94588.25
31949774-194977491.01391.33
42027878-202787894.65894.96
51958322-195832291.41291.70
62006314-200631493.65293.93
20min12001442-200144293.42494.632.1693.9295.132.15
21960845-196084591.52992.03
32023292-202329294.44494.96
42087064-208706497.42197.94
52035554-203555495.01795.50
62055174-205517495.93296.42
30min12061939-206193996.24896.722.4796.9697.432.45
21985377-198537792.67493.38
32065317-206531796.40697.13
42126923-212692399.282100.01
52072444-207244496.73997.44
62120368-212036898.97699.67
45min12078253-207825397.01097.322.8497.9398.252.83
21986330-198633092.71993.63
32065697-206569796.42497.37
42157020-2157020100.686101.64
52091409-209140997.62498.54
62131316-213131699.487100.41
60min12074736-207473696.84697.352.4597.9898.502.43
22000021-200002193.35894.48
32071115-207111596.67797.83
42148037-2148037100.267101.44
52099618-209961898.00799.14
62120331-212033198.974100.11
极限12076591-207659196.93297.382.5598.2898.742.54
21996155-199615593.17894.50
32071558-207155896.69798.07
42154527-2154527100.570101.97
52108807-210880798.43699.78
62109778-210977898.48199.84
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