非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430038-202402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%
110.654162894416341441616884157680415561841602590.09
210.774267257426486242660600.04
单位质量响应值RSD%判断
390634.65396105.850.99数据可信
供试品溶液-250601批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1314277-3142777.1847.208.247.187.208.23
2332626-3326267.6037.60
3352323-3523238.0538.05
4309380-3093807.0727.07
5275276-2752766.2926.29
6307374-3073747.0267.03
10min1648311-64831114.81914.512.7214.8314.522.71
2639490-63949014.61714.63
3652201-65220114.90814.92
4641420-64142014.66114.67
5613590-61359014.02514.04
6612943-61294314.01014.02
15min1741146-74114616.94116.830.9316.9816.870.94
2741367-74136716.94616.98
3737274-73727416.85216.89
4742422-74242216.97017.01
5728685-72868516.65616.69
6727020-72702016.61816.65
20min1776150-77615017.74117.710.3917.8117.780.40
2775856-77585617.73417.80
3778759-77875917.80017.87
4774323-77432317.69917.76
5773715-77371517.68517.75
6769914-76991417.59817.66
30min1803252-80325218.36018.290.4018.4518.380.38
2795811-79581118.19018.29
3800352-80035218.29418.39
4799513-79951318.27518.37
5798136-79813618.24318.33
6804196-80419618.38218.47
45min1820679-82067918.75918.720.7018.8818.840.70
2814889-81488918.62618.75
3822981-82298118.81118.94
4809359-80935918.50018.62
5820549-82054918.75618.88
6824456-82445618.84518.97
60min1826648-82664818.89518.890.3919.0519.050.38
2825889-82588918.87819.03
3829333-82933318.95619.11
4820912-82091218.76418.92
5826942-82694218.90219.05
6829935-82993518.97019.12
90min1834195-83419519.06819.070.6119.2619.260.59
2833923-83392319.06119.25
3832367-83236719.02619.22
4826698-82669818.89619.08
5836010-83601019.10919.29
6842102-84210219.24819.43
120min1839634-83963419.19219.020.9719.4119.240.96
2833404-83340419.04919.27
3835182-83518219.09019.31
4816835-81683518.67118.89
5831709-83170919.01119.23
6836802-83680219.12719.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1835346-83534619.09418.990.7719.3519.240.77
2823517-82351718.82319.07
3829899-82989918.96919.22
4822629-82262918.80319.05
5835854-83585419.10519.35
6836775-83677519.12719.38
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430038-202402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%
110.654205087420722742061194239465422858342172960.38
210.774289984428435442871690.10
单位质量响应值RSD%判断
395990.23398065.830.37数据可信
供试品溶液-250601批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1319365-3193657.2325.5931.377.235.5931.40
2256557-2565575.8105.81
3295284-2952846.6876.69
4103098-1030982.3352.33
5280408-2804086.3506.35
6225429-2254295.1055.11
10min1621321-62132114.07012.7912.9414.0812.8012.96
2593769-59376913.44613.46
3586584-58658413.28413.29
4419455-4194559.4999.50
5597083-59708313.52113.53
6570767-57076712.92612.93
15min1721747-72174716.34515.744.5816.3815.774.60
2711195-71119516.10616.14
3699870-69987015.84915.88
4632598-63259814.32614.35
5707671-70767116.02616.06
6697279-69727915.79115.82
20min1760468-76046817.22116.952.0317.2817.012.06
2757076-75707617.14517.20
3753253-75325317.05817.12
4718844-71884416.27916.32
5748040-74804016.94017.00
6753543-75354317.06517.12
30min1779492-77949217.65217.741.4317.7417.821.45
2788342-78834217.85317.94
3795552-79555218.01618.10
4764377-76437717.31017.38
5780372-78037217.67217.76
6791479-79147917.92418.01
45min1799088-79908818.09618.321.1218.2218.441.12
2817125-81712518.50518.62
3818658-81865818.53918.66
4801292-80129218.14618.25
5801982-80198218.16218.28
6815466-81546618.46718.58
60min1808032-80803218.29918.440.6618.4518.580.67
2814328-81432818.44118.59
3820043-82004318.57118.72
4810401-81040118.35218.48
5811409-81140918.37518.52
6821017-82101718.59318.74
90min1824573-82457318.67318.600.7218.8518.780.74
2826834-82683418.72418.90
3827511-82751118.74018.92
4812457-81245718.39918.56
5820350-82035018.57818.76
6817646-81764618.51618.69
120min1804030-80403018.20818.591.1218.4218.801.11
2825670-82567018.69818.91
3828713-82871318.76718.98
4817862-81786218.52118.71
5821981-82198118.61518.82
6827212-82721218.73318.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1831056-83105618.82018.531.6819.0618.771.67
2822465-82246518.62518.87
3828073-82807318.75218.99
4804719-80471918.22418.45
5797989-79798918.07118.31
6826213-82621318.71018.95
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430038-202402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%
110.654239864424162442415804241252424350142415640.04
210.774287632428489042862610.05
单位质量响应值RSD%判断
398268.92397981.520.06数据可信
供试品溶液-250602批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1171963-1719633.8845.6643.133.885.6643.11
2356462-3564628.0508.05
3161903-1619033.6563.66
4325365-3253657.3487.35
5360545-3605458.1428.14
6126501-1265012.8572.86
10min1548782-54878212.39313.369.6112.4013.389.65
2655915-65591514.81314.83
3539083-53908312.17412.18
4632931-63293114.29414.31
5640401-64040114.46214.48
6533708-53370812.05312.06
15min1696347-69634715.72616.063.6815.7516.103.71
2741071-74107116.73616.77
3689004-68900415.56015.59
4727035-72703516.41916.45
5734952-73495216.59816.64
6679514-67951415.34615.37
20min1745375-74537516.83317.021.8816.8917.081.90
2772608-77260817.44817.51
3744479-74447916.81316.87
4758643-75864317.13317.20
5765826-76582617.29517.36
6735802-73580216.61716.67
30min1784746-78474617.72217.750.8117.8017.840.83
2792426-79242617.89617.99
3786449-78644917.76117.84
4793776-79377617.92618.02
5783005-78300517.68317.78
6776701-77670117.54117.62
45min1801084-80108418.09118.141.0018.2018.261.01
2814881-81488118.40318.53
3809198-80919818.27418.38
4804759-80475918.17418.30
5794242-79424217.93718.06
6795603-79560317.96718.07
60min1816064-81606418.42918.370.6818.5718.520.68
2818799-81879918.49118.65
3819767-81976718.51318.65
4810387-81038718.30118.45
5805920-80592018.20018.35
6810196-81019618.29718.43
90min1825154-82515418.63518.490.6618.8118.670.65
2820205-82020518.52318.71
3824462-82446218.61918.79
4813748-81374818.37718.56
5812551-81255118.35018.53
6816390-81639018.43718.60
120min1827058-82705818.67818.500.8218.8818.710.79
2819496-81949618.50718.72
3825561-82556118.64418.85
4813747-81374718.37718.59
5809883-80988318.29018.50
6820679-82067918.53418.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1819947-81994718.51718.441.0618.7518.681.05
2818278-81827818.47918.73
3807722-80772218.24118.47
4830734-83073418.76119.00
5807832-80783218.24418.49
6815803-81580318.42418.65
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