多替诺雷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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.953631436371361893619036061362250.34
211.053662636859367420.45
单位质量响应值RSD%判断
3308.223325.070.36数据可信
供试品溶液-J187N批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14599-459912.44110.758.0512.4410.758.05
23990-399010.79410.79
33909-390910.57510.57
43745-374510.13110.13
53756-375610.16110.16
63847-384710.40710.41
10min17711-771120.86021.083.3520.8821.103.34
27661-766120.72420.74
37628-762820.63520.65
47515-751520.33020.35
58096-809621.90121.92
68139-813922.01822.03
15min110464-1046428.30728.282.4028.3628.342.40
210262-1026227.76127.81
310298-1029827.85827.91
410204-1020427.60427.65
510675-1067528.87828.93
610829-1082929.29529.35
20min112420-1242033.59833.542.6333.7033.642.62
212161-1216132.89833.00
312376-1237633.47933.58
411979-1197932.40532.50
512522-1252233.87433.98
612927-1292734.97035.07
30min115426-1542641.73042.051.5841.8942.211.58
215272-1527241.31441.47
315480-1548041.87642.03
415414-1541441.69841.85
515922-1592243.07243.23
615762-1576242.63942.80
45min118502-1850250.05150.221.4650.2850.441.47
218176-1817649.17049.39
318720-1872050.64150.87
418347-1834749.63249.85
518748-1874850.71750.95
618887-1888751.09351.33
60min120796-2079656.25756.630.9856.5756.940.99
220792-2079256.24656.55
320740-2074056.10656.41
420938-2093856.64156.94
521058-2105856.96657.28
621277-2127757.55857.88
90min123986-2398664.88764.511.6365.2964.911.62
223358-2335863.18863.59
323626-2362663.91364.31
423565-2356563.74864.15
524196-2419665.45565.86
624339-2433965.84266.25
120min125932-2593270.15170.030.9670.6670.540.97
225658-2565869.41069.91
325647-2564769.38069.89
425727-2572769.59670.10
526146-2614670.73071.25
626206-2620670.89271.42
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126666-2666672.13772.451.6372.7773.081.63
226224-2622470.94171.56
326836-2683672.59773.22
426469-2646971.60472.22
527460-2746074.28574.92
627029-2702973.11973.76
多替诺雷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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.957247672582726907291972763726860.24
211.057375873724737410.04
单位质量响应值RSD%判断
6637.996673.390.38数据可信
供试品溶液-J057M批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17128-71289.6099.568.319.619.568.30
26513-65138.7808.78
36757-67579.1099.11
48169-816911.01211.01
56762-67629.1159.12
67225-72259.7409.74
10min112707-1270717.13016.912.2717.1516.932.28
212148-1214816.37616.39
312257-1225716.52316.54
412861-1286117.33717.36
512544-1254416.91016.93
612738-1273817.17117.19
15min117302-1730223.32423.281.8623.3723.331.86
216850-1685022.71522.76
317053-1705322.98823.03
417196-1719623.18123.23
517460-1746023.53723.58
617769-1776923.95324.00
20min120307-2030727.37527.691.3027.4627.781.29
220325-2032527.39927.48
320354-2035427.43827.52
420606-2060627.77827.86
520687-2068727.88727.97
620976-2097628.27728.36
30min125111-2511133.85134.221.6033.9834.341.60
224946-2494633.62833.75
325235-2523534.01834.14
425380-2538034.21334.35
525527-2552734.41234.54
626096-2609635.17935.31
45min130329-3032940.88541.081.2141.0741.261.21
230003-3000340.44540.63
330446-3044641.04341.23
430571-3057141.21141.40
530368-3036840.93741.12
631115-3111541.94442.13
60min134001-3400145.83546.281.3146.0946.531.32
233771-3377145.52545.77
334488-3448846.49146.74
434278-3427846.20846.47
534350-3435046.30546.56
635080-3508047.28947.55
90min139023-3902352.60553.080.8452.9353.420.84
239246-3924652.90553.23
339763-3976353.60253.93
439068-3906852.66553.00
539398-3939853.11053.44
639776-3977653.62053.96
120min142583-4258357.40457.550.8357.8257.960.83
242098-4209856.75057.16
342904-4290457.83658.26
442566-4256657.38157.80
542908-4290857.84258.26
643074-4307458.06658.49
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143539-4353958.69259.100.9159.2159.620.90
243693-4369358.90059.41
344282-4428259.69460.21
443588-4358858.75959.28
543554-4355458.71359.23
644411-4441159.86860.39
多替诺雷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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.955404725426515443175456805458405437920.42
211.055489335488155488740.02
单位质量响应值RSD%判断
49661.3749671.860.02数据可信
供试品溶液-4229B批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13990-39900.7210.6518.030.720.6418.26
23748-37480.6770.68
33720-37200.6720.67
42336-23360.4220.42
53502-35020.6330.63
64131-41310.7460.75
10min13927-39270.7091.0128.650.711.0228.67
27568-75681.3671.37
37463-74631.3481.35
45786-57861.0451.05
54623-46230.8350.84
64275-42750.7720.77
15min15703-57031.0300.968.831.030.968.94
25755-57551.0401.04
35499-54990.9931.00
45215-52150.9420.94
55155-51550.9310.93
64489-44890.8110.81
20min14989-49890.9010.9810.030.910.989.88
25899-58991.0661.07
36003-60031.0841.09
45762-57621.0411.04
54858-48580.8780.88
64889-48890.8830.89
30min15233-52330.9450.9911.100.951.0011.17
26525-65251.1791.19
35108-51080.9230.93
45896-58961.0651.07
55192-51920.9380.94
64933-49330.8910.90
45min16238-62381.1271.0011.231.131.0011.17
25632-56321.0171.03
35034-50340.9090.92
46260-62601.1311.14
55116-51160.9240.93
64854-48540.8770.88
60min15990-59901.0820.9813.221.090.9913.14
25695-56951.0291.04
35999-59991.0841.09
45809-58091.0491.06
54348-43480.7850.79
64697-46970.8480.86
90min17070-70701.2771.0515.171.291.0615.12
24867-48670.8790.89
35447-54470.9841.00
46590-65901.1901.20
55746-57461.0381.05
65009-50090.9050.91
120min15769-57691.0420.957.661.060.967.71
25031-50310.9090.92
34969-49690.8980.91
45709-57091.0311.04
54817-48170.8700.88
65134-51340.9270.94
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14481-44810.8090.907.750.820.917.65
24834-48340.8730.89
34703-47030.8500.86
45588-55881.0091.02
55131-51310.9270.94
65022-50220.9070.92
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