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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.421996775199205319940371992505199235619935450.10
210.342004941200844720066940.13
单位质量响应值RSD%判断
191319.10194070.991.01数据可信
长期12月-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%
5min1802846-80284637.46240.7718.2837.4640.7718.27
2856736-85673639.97739.98
3910882-91088242.50342.50
4683623-68362331.89931.90
5827893-82789338.63138.63
61161008-116100854.17454.17
10min11507761-150776170.35575.998.0870.4476.088.08
21738968-173896881.14381.23
31592332-159233274.30174.40
41464301-146430168.32768.40
51666780-166678077.77577.86
61801470-180147084.05984.18
15min11876160-187616087.54589.272.2487.7889.532.26
21940973-194097390.56990.84
31887027-188702788.05288.31
41870347-187034787.27387.50
51925555-192555589.84990.11
61978882-197888292.33892.64
20min11994774-199477493.07993.461.9293.5193.921.93
22022124-202212494.35694.83
32006800-200680093.64094.10
41986702-198670292.70393.12
51945643-194564390.78791.25
62060921-206092196.16696.68
30min12075664-207566496.85497.500.7197.4998.160.73
22089901-208990197.51898.20
32078689-207868996.99597.66
42082741-208274197.18497.81
52093886-209388697.70498.36
62116040-211604098.73899.46
45min12113380-211338098.61499.170.5899.47100.050.60
22130506-213050699.413100.31
32112284-211228498.56399.44
42119836-211983698.91599.75
52131952-213195299.480100.36
62143469-2143469100.018100.96
60min12133607-213360799.55899.670.52100.63100.780.54
22130677-213067799.421100.54
32126726-212672699.236100.33
42136465-213646599.691100.75
52131714-213171499.469100.57
62157424-2157424100.669101.84
极限12142017-214201799.95099.920.58101.25101.240.60
22135657-213565799.653100.99
32129838-212983899.382100.70
42131963-213196399.481100.76
52145249-2145249100.101101.42
62163429-2163429100.949102.34
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.422013858201679320211792020198201978220183620.15
210.341996551199671719966340.01
单位质量响应值RSD%判断
193700.77193098.070.23数据可信
长期12月-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%
5min11272631-127263159.16451.9816.8359.1651.9816.83
21215001-121500156.48556.48
31163017-116301754.06854.07
41164150-116415054.12154.12
51147537-114753753.34853.35
6745701-74570134.66734.67
10min11842487-184248785.65682.583.2685.7982.693.28
21784931-178493182.98083.11
31786974-178697483.07583.20
41805222-180522283.92484.04
51767330-176733082.16282.28
61670399-167039977.65677.73
15min11996189-199618992.80291.571.1993.1291.871.20
21974009-197400991.77092.08
31969851-196985191.57791.88
41992366-199236692.62492.93
51945860-194586090.46290.76
61939709-193970990.17690.43
20min12074102-207410296.42495.420.8996.9595.920.90
22048175-204817595.21895.73
32046849-204684995.15795.67
42075049-207504996.46896.98
52030425-203042594.39394.90
62040766-204076694.87495.32
30min12129667-212966799.00798.210.9799.7598.920.98
22109345-210934598.06298.79
32109812-210981298.08498.80
42140233-214023399.498100.23
52081772-208177296.78097.49
62103920-210392097.81098.47
45min12156180-2156180100.24099.780.81101.20100.720.81
22140788-214078899.524100.47
32136989-213698999.347100.29
42174005-2174005101.068102.02
52123631-212363198.72699.65
62146371-214637199.783100.66
60min12169393-2169393100.854100.320.76102.04101.480.76
22144029-214402999.675100.84
32160556-2160556100.443101.60
42181072-2181072101.397102.57
52136630-213663099.331100.48
62155733-2155733100.219101.32
极限12168530-2168530100.814100.470.82102.22101.850.82
22156665-2156665100.262101.65
32158632-2158632100.353101.74
42190221-2190221101.822103.22
52136820-213682099.339100.71
62156105-2156105100.236101.56
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.422007318200672820053582005569200243020054810.10
210.342029256202580520275300.13
单位质量响应值RSD%判断
192464.59196086.071.32数据可信
长期12月-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%
5min11097287-109728750.78751.7511.3550.7951.7511.34
21177726-117772654.51054.51
31293163-129316359.85259.85
41040635-104063548.16448.16
51172916-117291654.28754.29
6926435-92643542.87942.88
10min11749754-174975480.98582.552.3781.1082.662.38
21783784-178378482.56082.68
31862811-186281186.21886.35
41762892-176289281.59381.70
51789921-178992182.84482.96
61752229-175222981.10081.19
15min11973392-197339291.33691.861.0491.6392.161.04
21988490-198849092.03592.34
32022439-202243993.60693.93
41971382-197138291.24391.53
51965966-196596690.99291.30
61987059-198705991.96892.24
20min12064491-206449195.55295.880.7796.0596.380.77
22064324-206432495.54596.05
32097645-209764597.08797.62
42064088-206408895.53496.02
52055129-205512995.11995.63
62083120-208312096.41596.89
30min12118291-211829198.04298.471.0598.7599.191.05
22127145-212714598.45299.17
32158944-215894499.924100.67
42120820-212082098.15998.86
52095327-209532796.97997.70
62144972-214497299.27799.97
45min12165263-2165263100.216100.031.03101.14100.961.03
22172170-2172170100.536101.48
32183764-2183764101.073102.04
42146057-214605799.327100.25
52124159-212415998.31499.25
62175535-2175535100.692101.61
60min12160801-2160801100.010100.290.87101.16101.450.87
22169942-2169942100.433101.60
32197489-2197489101.708102.90
42148604-214860499.445100.59
52148267-214826799.430100.58
62176055-2176055100.716101.85
极限12164396-2164396100.176100.211.11101.55101.591.10
22164396-2164396100.176101.56
32194919-2194919101.589103.01
42162520-2162520100.089101.45
52123968-212396898.30599.68
62181109-2181109100.950102.31
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.422072820207257720751022077793207670420749990.12
210.342072507206695620697320.19
单位质量响应值RSD%判断
199136.18200167.500.37数据可信
长期12月-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%
5min1976157-97615743.96043.6721.0443.9643.6721.04
2911002-91100241.02641.03
3827772-82777237.27837.28
41345654-134565460.60060.60
5763424-76342434.38034.38
6994096-99409644.76844.77
10min11786624-178662480.45876.795.7680.5676.895.78
21713165-171316577.15077.24
31635700-163570073.66273.74
41842525-184252582.97683.11
51679253-167925375.62375.70
61574235-157423570.89470.99
15min12020933-202093391.01088.393.1591.2988.663.15
21966937-196693788.57888.84
31931150-193115086.96787.21
42002597-200259790.18490.50
51999686-199968690.05390.30
61854855-185485583.53183.79
20min12107917-210791794.92793.101.5295.4193.561.52
22066489-206648993.06293.52
32050473-205047392.34092.78
42063805-206380592.94193.46
52095096-209509694.35094.79
62020502-202050290.99191.43
30min12186274-218627498.45696.501.6599.1597.171.65
22140459-214045996.39397.06
32109388-210938894.99495.64
42131725-213172595.99996.73
52183677-218367798.33998.99
62105030-210503094.79795.44
45min12213958-221395899.70397.951.30100.6198.841.29
22167583-216758397.61498.49
32141896-214189696.45797.31
42158179-215817997.19198.13
52204696-220469699.286100.16
62164535-216453597.47798.33
60min12198311-219831198.99897.841.29100.1398.941.28
22167379-216737997.60598.70
32150200-215020096.83197.90
42150151-215015196.82997.98
52215298-221529899.763100.86
62153711-215371196.99098.06
极限12207063-220706399.39297.861.29100.7499.181.28
22173279-217327997.87199.19
32147946-214794696.73098.02
42151315-215131596.88298.25
52207269-220726999.401100.72
62151334-215133496.88398.17
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