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%
110.041915267191521919153071915506191419919151000.03
210.171950109195115419506320.04
单位质量响应值RSD%判断
190747.01191802.560.40数据可信
供试品溶液-2024112321批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11334450-133445062.79057.9413.5862.7957.9413.58
2995888-99588846.86046.86
31039299-103929948.90248.90
41334664-133466462.80062.80
51312793-131279361.77161.77
61370946-137094664.50764.51
10min12042644-204264496.11390.635.7496.2590.765.75
21776000-177600083.56683.67
31814579-181457985.38285.49
42008527-200852794.50794.65
51915039-191503990.10890.25
61999979-199997994.10594.25
15min12046103-204610396.27595.521.6596.6395.851.68
21992670-199267093.76194.05
31996491-199649193.94194.24
42063777-206377797.10797.46
52013747-201374794.75395.09
62067762-206776297.29597.65
20min12054710-205471096.68096.620.6497.2597.160.67
22038908-203890895.93796.44
32036549-203654995.82696.33
42069025-206902597.35497.92
52058139-205813996.84297.39
62062960-206296097.06997.64
30min12043691-204369196.16297.100.7196.9497.860.72
22048345-204834596.38197.09
32063814-206381497.10997.83
42075785-207578597.67298.45
52076096-207609697.68798.45
62074364-207436497.60598.39
45min12041586-204158696.06397.080.5797.0698.050.57
22063178-206317897.07998.00
32063260-206326097.08398.02
42065312-206531297.17998.18
52068676-206867697.33898.32
62076820-207682097.72198.72
60min12041136-204113696.04296.930.6397.2598.120.64
22052082-205208296.55797.70
32055307-205530796.70997.86
42070773-207077397.43698.65
52065762-206576297.20098.40
62075413-207541397.65598.87
极限12034197-203419795.71596.720.6897.1498.120.68
22045906-204590696.26697.62
32052481-205248196.57697.94
42067766-206776697.29598.73
52068494-206849497.32998.74
62064631-206463197.14798.58
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%
110.041929093192887319285541924846192673419276200.10
210.171966530196532919659300.05
单位质量响应值RSD%判断
191994.02193306.780.49数据可信
供试品溶液-2024112421批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11749031-174903181.71078.0910.2981.7178.0910.29
21804666-180466684.30984.31
31748272-174827281.67581.67
41792118-179211883.72383.72
51366652-136665263.84663.85
61568345-156834573.26973.27
10min12185346-2185346102.093101.720.87102.28101.890.88
22205372-2205372103.029103.22
32187869-2187869102.211102.39
42165784-2165784101.180101.37
52165008-2165008101.143101.29
62154272-2154272100.642100.80
15min12204200-2204200102.974102.680.72103.38103.080.72
22218893-2218893103.661104.08
32207897-2207897103.147103.56
42177174-2177174101.712102.12
52195502-2195502102.568102.93
62183430-2183430102.004102.39
20min12205580-2205580103.039102.780.78103.68103.410.78
22222162-2222162103.813104.46
32211844-2211844103.331103.97
42176556-2176556101.683102.32
52200105-2200105102.783103.38
62184454-2184454102.052102.66
30min12200479-2200479102.800102.760.71103.67103.620.72
22222200-2222200103.815104.69
32210830-2210830103.284104.15
42180972-2180972101.889102.75
52199095-2199095102.736103.56
62184497-2184497102.054102.89
45min12205454-2205454103.033102.640.84104.13103.730.85
22222808-2222808103.844104.95
32209776-2209776103.235104.33
42180397-2180397101.862102.95
52187736-2187736102.205103.26
62176632-2176632101.686102.75
60min12196830-2196830102.630102.420.96103.95103.740.96
22220626-2220626103.742105.08
32203996-2203996102.965104.29
42168573-2168573101.310102.63
52197699-2197699102.671103.95
62166772-2166772101.226102.52
极限12196871-2196871102.632102.410.80104.18103.960.81
22215597-2215597103.507105.08
32202320-2202320102.886104.44
42173133-2173133101.523103.06
52195324-2195324102.560104.07
62170082-2170082101.380102.90
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%
110.041953665195351019531211952520195198919529610.04
210.171960952196231619616340.05
单位质量响应值RSD%判断
194518.03192884.370.60数据可信
供试品溶液-2024112422批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11146470-114647053.27066.2520.9953.2766.2420.99
21600394-160039474.36174.36
31623708-162370875.44475.44
41397827-139782764.94964.95
51007722-100772246.82346.82
61778294-177829482.62782.63
10min12124501-212450198.71395.644.4898.8395.794.49
22082474-208247496.76096.93
32089254-208925497.07597.24
42076148-207614896.46696.61
51873546-187354687.05387.16
62104144-210414497.76797.95
15min12176146-2176146101.11398.461.34101.4598.821.33
22104443-210444397.78198.16
32107135-210713597.90698.29
42107224-210722497.91098.27
52104300-210430097.77498.07
62114719-211471998.25998.66
20min12184849-2184849101.51798.821.36102.0899.401.34
22111658-211165898.11698.71
32107786-210778697.93698.54
42120237-212023798.51599.09
52118413-211841398.43098.95
62118461-211846198.43299.05
30min12181798-2181798101.37598.741.33102.1699.541.31
22114128-211412898.23199.05
32111291-211129198.09998.92
42116688-211668898.35099.15
52119405-211940598.47699.21
62106763-210676397.88998.73
45min12178410-2178410101.21898.661.30102.2399.671.29
22109490-210949098.01699.05
32105388-210538897.82598.86
42121733-212173398.58599.60
52111979-211197998.13199.08
62112628-211262898.16199.22
60min12174941-2174941101.05798.431.35102.3099.671.33
22102640-210264097.69798.95
32099928-209992897.57198.83
42116836-211683698.35799.59
52114768-211476898.26199.43
62101957-210195797.66698.94
极限12170232-2170232100.83898.241.33102.3099.691.31
22098390-209839097.50098.97
32095838-209583897.38198.85
42110807-211080798.07799.53
52104075-210407597.76499.15
62106344-210634497.86999.36
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