苯磺酸美洛加巴林片项目信息
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405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 19.431959131963341964681962721955171961010.20
219.371953331961781957560.31
单位质量响应值RSD%判断
10092.6910106.140.10数据可信
供试品溶液-25011001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%
5min1176725-17672589.48391.332.9189.4891.322.91
2182658-18265892.48792.49
3176507-17650789.37289.37
4189702-18970296.05396.05
5176283-17628389.25989.26
6180311-18031191.29891.30
10min1187045-18704594.70895.431.7094.8695.581.71
2192122-19212297.27997.43
3185863-18586394.10994.26
4192181-19218197.30997.47
5184589-18458993.46493.61
6189013-18901395.70495.86
15min1187473-18747394.92595.791.5495.2396.101.55
2192809-19280997.62697.94
3186533-18653394.44994.75
4191875-19187597.15497.48
5185954-18595494.15694.46
6190416-19041696.41596.73
20min1187242-18724294.80895.661.3895.2796.141.38
2192749-19274997.59698.08
3186758-18675894.56395.03
4190812-19081296.61597.10
5186239-18623994.30094.76
6189796-18979696.10196.57
30min1186463-18646394.41395.451.5095.0496.081.50
2192704-19270497.57398.21
3186225-18622594.29394.91
4190981-19098196.70197.35
5185905-18590594.13194.75
6188740-18874095.56696.20
45min1186607-18660794.48695.421.4595.2796.221.45
2192427-19242797.43398.24
3186122-18612294.24195.02
4190468-19046896.44197.25
5185748-18574894.05194.83
6189376-18937695.88896.68
极限1187036-18703694.70395.071.4195.6496.021.42
2191837-19183797.13498.10
3185136-18513693.74194.68
4189554-18955495.97896.95
5184979-18497993.66294.59
6187998-18799895.19096.14
苯磺酸美洛加巴林片项目信息
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405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 19.431959021959461957621961641955001958550.13
219.371952841949111950980.14
单位质量响应值RSD%判断
10080.0310072.170.06数据可信
供试品溶液-25011001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%
5min1172982-17298287.79089.353.9687.7989.353.96
2186753-18675394.77994.78
3166940-16694084.72484.72
4175324-17532488.97988.98
5173190-17319087.89687.90
6181177-18117791.94991.95
10min1189069-18906995.95495.302.5696.1095.452.56
2192862-19286297.87998.04
3181454-18145492.09092.23
4191496-19149697.18697.33
5182241-18224192.48992.64
6189551-18955196.19996.35
15min1189412-18941296.12895.532.5696.4395.842.56
2193405-19340598.15598.48
3181863-18186392.29792.59
4192059-19205997.47297.78
5182815-18281592.78093.08
6189826-18982696.33896.65
20min1189255-18925596.04995.452.4796.5295.922.47
2192969-19296997.93498.42
3182296-18229692.51792.97
4191905-19190597.39497.87
5182429-18242992.58493.04
6189539-18953996.19396.67
30min1188639-18863995.73695.222.4596.3695.842.46
2192704-19270497.79998.45
3181811-18181192.27192.87
4191751-19175197.31597.95
5182394-18239492.56793.18
6188378-18837895.60496.24
45min1188562-18856295.69795.042.4996.4895.832.49
2192114-19211497.50098.31
3181329-18132992.02692.78
4191367-19136797.12197.92
5181812-18181292.27193.04
6188434-18843495.63296.43
极限1188156-18815695.49194.822.5096.4495.762.50
2191827-19182797.35498.33
3180994-18099491.85692.77
4190794-19079496.83097.79
5181248-18124891.98592.90
6187940-18794095.38196.33
苯磺酸美洛加巴林片项目信息
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405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 19.431959231960341956941953141951951956320.19
219.371954371956211955290.07
单位质量响应值RSD%判断
10068.5510094.420.19数据可信
供试品溶液-25011001批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168614-16861485.52890.002.5685.5390.002.56
2181253-18125391.93991.94
3178195-17819590.38790.39
4177221-17722189.89389.89
5179593-17959391.09791.10
6179693-17969391.14791.15
10min1177806-17780690.19093.072.1590.3393.222.15
2186886-18688694.79694.95
3181632-18163292.13192.28
4188901-18890195.81895.97
5182493-18249392.56892.72
6183223-18322392.93893.09
15min1178778-17877890.68393.172.0590.9893.482.05
2187025-18702594.86695.18
3181665-18166592.14892.45
4189118-18911895.92896.24
5182998-18299892.82493.13
6182525-18252592.58492.89
20min1179186-17918690.89093.182.0591.3393.642.05
2187469-18746995.09295.56
3181909-18190992.27192.73
4189052-18905295.89596.36
5182025-18202592.33092.79
6182513-18251392.57893.04
30min1179292-17929290.94493.222.0591.5493.842.05
2187331-18733195.02295.65
3181562-18156292.09592.71
4189280-18928096.01096.64
5182737-18273792.69193.31
6182448-18244892.54593.16
45min1179187-17918790.89193.112.0291.6493.882.02
2187295-18729595.00395.79
3181327-18132791.97692.74
4188810-18881095.77296.56
5182119-18211992.37893.15
6182581-18258192.61293.38
极限1178815-17881590.70292.772.0191.6093.692.00
2186757-18675794.73095.67
3180561-18056191.58892.51
4188031-18803195.37796.33
5181454-18145492.04192.96
6181692-18169292.16193.09
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