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%
19.531795154179608517961871794483179401117951840.06
29.641818539181890318187210.02
单位质量响应值RSD%判断
188371.88188664.000.11数据可信
供试品溶液-2024112321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%
5min1105641-1056415.0437.0738.555.047.0738.56
2187970-1879708.9748.97
3213372-21337210.18710.19
490907-909074.3404.34
593622-936224.4704.47
6197155-1971559.4129.41
10min1335330-33533016.00917.4613.0416.0217.4813.07
2385556-38555618.40718.43
3433302-43330220.68620.71
4354033-35403316.90216.91
5296702-29670214.16514.17
6389840-38984018.61118.63
15min1452493-45249321.60222.083.8121.6522.143.84
2460837-46083722.00122.06
3492292-49229223.50223.57
4462701-46270122.09022.14
5439337-43933720.97421.02
6467528-46752822.32022.38
20min1523754-52375425.00425.533.4825.1025.643.51
2565922-56592227.01827.13
3543220-54322025.93426.05
4532412-53241225.41825.51
5511161-51116124.40324.49
6532597-53259725.42725.54
30min1601180-60118028.70129.091.8728.8529.251.89
2606676-60667628.96329.13
3614519-61451929.33829.52
4609384-60938429.09329.25
5595701-59570128.43928.58
6628311-62831129.99630.16
45min1696503-69650333.25231.613.0633.4731.843.02
2653896-65389631.21831.45
3659715-65971531.49531.74
4668639-66863931.92132.14
5658976-65897631.46031.67
6634906-63490630.31130.55
60min1684691-68469132.68832.861.8932.9833.161.87
2691331-69133133.00533.31
3694822-69482233.17133.49
4703035-70303533.56333.85
5691016-69101632.99033.27
6664810-66481031.73932.04
极限1723896-72389634.55934.302.1234.9234.672.09
2722009-72200934.46934.85
3728960-72896034.80135.19
4719316-71931634.34134.70
5728543-72854334.78135.13
6688487-68848732.86933.24
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%
19.531799860179931217980901796005179575717978050.11
29.641842338184214118422400.01
单位质量响应值RSD%判断
188646.90191103.730.92数据可信
供试品溶液-2024112321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%
5min1214186-21418610.1538.2220.2210.158.2220.18
2118677-1186775.6255.63
3208077-2080779.8639.86
4176377-1763778.3618.36
5161324-1613247.6477.65
6161931-1619317.6767.68
10min1388477-38847718.41417.058.4318.4417.088.43
2309582-30958214.67514.69
3389189-38918918.44818.47
4372580-37258017.66117.68
5350791-35079116.62816.65
6348076-34807616.49916.52
15min1487925-48792523.12822.482.8023.1922.542.81
2472579-47257922.40122.45
3487340-48734023.10123.16
4478899-47889922.70122.76
5453893-45389321.51521.57
6465083-46508322.04622.10
20min1545938-54593825.87825.893.2125.9926.003.21
2542546-54254625.71725.81
3550096-55009626.07526.19
4539586-53958625.57725.69
5522730-52273024.77824.88
6576421-57642127.32327.43
30min1613892-61389229.09928.882.1629.2729.042.16
2597438-59743828.31928.47
3625088-62508829.63029.80
4622657-62265729.51529.68
5600828-60082828.48028.64
6595215-59521528.21428.38
45min1664439-66443931.49531.371.6431.7331.601.64
2662313-66231331.39531.61
3675065-67506531.99932.24
4665280-66528031.53531.77
5661877-66187731.37431.59
6641995-64199530.43230.66
60min1693749-69374932.88532.912.0233.1933.212.01
2692297-69229732.81633.10
3715873-71587333.93334.24
4700220-70022033.19133.49
5690689-69068932.74033.03
6672822-67282231.89332.19
极限1785176-78517637.21935.183.5437.6035.553.51
2746097-74609735.36635.72
3747054-74705435.41135.80
4741253-74125335.13735.51
5727120-72712034.46734.83
6705909-70590933.46133.83
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%
19.531797364179780917972871796372179651717970700.04
29.641831980183169618318380.02
单位质量响应值RSD%判断
188569.78190024.690.55数据可信
供试品溶液-2024112421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%
5min1185731-1857318.8319.2914.328.839.2914.32
2216381-21638110.28810.29
3150392-1503927.1507.15
4208029-2080299.8919.89
5228001-22800110.84010.84
6183969-1839698.7478.75
10min1363810-36381017.29717.646.7417.3217.666.73
2392904-39290418.68118.70
3326907-32690715.54315.56
4391885-39188518.63218.65
5384599-38459918.28618.31
6366093-36609317.40617.43
15min1470200-47020022.35622.463.5422.4122.523.56
2483789-48378923.00223.07
3443540-44354021.08821.14
4491828-49182823.38423.45
5477920-47792022.72322.79
6467668-46766822.23522.29
20min1539248-53924825.63925.812.9925.7525.922.99
2543540-54354025.84325.96
3525962-52596225.00725.10
4573275-57327527.25627.37
5533647-53364725.37225.49
6540901-54090125.71725.82
30min1619049-61904929.43328.862.6929.6029.032.67
2614875-61487529.23429.41
3616150-61615029.29529.45
4608099-60809928.91229.09
5609265-60926528.96729.14
6574868-57486827.33227.50
45min1683183-68318332.48231.911.9432.7132.141.93
2676550-67655032.16732.40
3683299-68329932.48732.71
4671206-67120631.91232.15
5663454-66345431.54431.78
6649619-64961930.88631.11
60min1712219-71221933.86233.183.3834.1633.483.36
2708338-70833833.67833.99
3715381-71538134.01334.30
4693917-69391732.99233.30
5704740-70474033.50733.81
6652132-65213231.00631.30
极限1751835-75183535.74634.951.9836.1235.321.97
2743608-74360835.35535.74
3744147-74414735.38035.75
4734164-73416434.90635.29
5723651-72365134.40634.79
6713036-71303633.90134.26
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%
19.531828332182891818283501825127182165718264770.17
29.641839276184068918399820.06
单位质量响应值RSD%判断
191655.51190869.500.30数据可信
供试品溶液-2024112421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%
5min1209339-2093399.8519.6722.669.859.6722.66
2194888-1948889.1719.17
3237741-23774111.18711.19
4272337-27233712.81512.82
5137625-1376256.4766.48
6181056-1810568.5208.52
10min1404049-40404919.01317.938.3719.0317.958.38
2380663-38066317.91217.93
3374265-37426517.61117.64
4425517-42551720.02320.05
5332030-33203015.62415.64
6369865-36986517.40417.42
15min1493288-49328823.21222.724.5123.2822.784.54
2480924-48092422.63022.69
3488816-48881623.00223.07
4512276-51227624.10624.18
5447094-44709421.03821.09
6474209-47420922.31422.37
20min1557667-55766726.24225.543.3626.3625.653.37
2543553-54355325.57725.69
3524068-52406824.66124.78
4569025-56902526.77626.90
5523218-52321824.62124.72
6538770-53877025.35225.46
30min1625421-62542129.43029.241.7229.6029.401.74
2622159-62215929.27629.44
3610276-61027628.71728.89
4639562-63956230.09530.28
5611944-61194428.79628.95
6618649-61864929.11129.27
45min1688372-68837232.39232.301.3032.6332.541.32
2688350-68835032.39132.62
3674324-67432431.73131.96
4699361-69936132.90933.16
5678658-67865831.93532.15
6689941-68994132.46632.69
60min1713732-71373233.58534.092.8433.9034.402.84
2722789-72278934.01234.32
3704824-70482433.16633.47
4763178-76317835.91236.24
5714720-71472033.63233.92
6728118-72811834.26234.56
极限1753400-75340035.45234.753.3635.8435.133.34
2747946-74794635.19535.58
3689738-68973832.45632.83
4757270-75727035.63436.04
5739282-73928234.78835.15
6742966-74296634.96135.34
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