塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.173008390300751230118223003804300760830078270.10
210.113007176301117130091740.10
单位质量响应值RSD%判断
295754.87297643.320.46数据可信
供试品溶液-23004N1批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1747397-74739725.09023.307.3625.0923.307.36
2648638-64863821.77521.77
3647377-64737721.73221.73
4753395-75339525.29125.29
5717581-71758124.08924.09
6650759-65075921.84621.85
10min11232599-123259941.37842.723.5941.4342.773.59
21259356-125935642.27642.32
31241125-124112541.66441.71
41287293-128729343.21443.26
51357403-135740345.56845.62
61258005-125800542.23142.27
15min11809608-180960860.74861.783.2460.8861.913.24
21826802-182680261.32561.45
31788535-178853560.04160.17
41832473-183247361.51661.65
51957220-195722065.70365.84
61826907-182690761.32961.46
20min12241365-224136575.24276.151.3275.5076.401.32
22269274-226927476.17976.43
32230332-223033274.87275.12
42277665-227766576.46176.72
52314148-231414877.68577.96
62277103-227710376.44276.69
30min12745632-274563292.17092.630.9392.5793.040.93
22760942-276094292.68493.09
32717163-271716391.21491.61
42763057-276305792.75593.17
52786985-278698593.55893.98
62781917-278191793.38893.79
45min12924047-292404798.15998.872.0398.7599.462.03
22912058-291205897.75798.35
32917733-291773397.94798.53
42914150-291415097.82798.43
53065534-3065534102.909103.52
62937475-293747598.61099.20
60min12950751-295075199.05698.980.3899.8499.770.39
22931966-293196698.42599.21
32941795-294179598.75599.53
42948145-294814598.96899.76
52964308-296430899.511100.33
62954249-295424999.17399.96
极限12998143-2998143100.647100.670.39101.63101.660.39
22976857-297685799.932100.91
33010908-3010908101.075102.05
43003159-3003159100.815101.81
53002716-3002716100.800101.82
63000720-3000720100.733101.72
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.173018316301965530188363018766301760830186360.03
210.113024843302398430244140.03
单位质量响应值RSD%判断
296817.70299150.740.56数据可信
供试品溶液-23004N1批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1729845-72984524.39522.6810.9224.4022.6810.92
2541082-54108218.08618.09
3732873-73287324.49624.50
4703744-70374423.52323.52
5647677-64767721.64921.65
6715605-71560523.91923.92
10min11310011-131001143.78742.575.4443.8442.625.44
21147669-114766938.36138.40
31274031-127403142.58542.63
41337137-133713744.69444.74
51252326-125232641.85941.90
61320985-132098544.15444.20
15min11876497-187649762.72260.744.8062.8660.874.81
21664847-166484755.64855.76
31824643-182464360.98961.12
41914791-191479164.00264.14
51782825-178282559.59159.72
61839043-183904361.47061.61
20min12284847-228484776.37174.633.3176.6374.883.32
22095598-209559870.04670.27
32272224-227222475.94976.21
42294958-229495876.70976.97
52234769-223476974.69774.94
62214248-221424874.01174.27
30min12759709-275970992.24491.231.8792.6691.631.88
22639260-263926088.21888.58
32757121-275712192.15792.57
42778561-277856192.87493.29
52737128-273712891.48991.88
62704323-270432390.39290.80
45min12918957-291895797.56697.220.7298.1797.800.74
22871615-287161595.98496.52
32911261-291126197.30997.90
42933488-293348898.05298.66
52903500-290350097.05097.63
62912411-291241197.34897.94
60min12945018-294501898.43898.440.3599.2399.220.36
22949202-294920298.57799.31
32943348-294334898.38299.17
42953362-295336298.71699.52
52925856-292585697.79798.57
62953622-295362298.72599.51
极限12990014-299001499.94298.981.02100.9399.951.02
22923878-292387897.73198.66
32969927-296992799.270100.25
42933082-293308298.03999.04
52952452-295245298.68699.65
62997581-2997581100.194101.17
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