缬沙坦氨氯地平片项目信息
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100374-202106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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.972471722470212472142472302469192471110.06
213.942484112481422482760.08
单位质量响应值RSD%判断
17688.6917810.330.49数据可信
供试品溶液-25021101-2-1批-氨氯地平-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%
15min11029035-1029035375.831366.411.79375.83366.411.79
2986169-986169360.175360.17
31013729-1013729370.240370.24
4991988-991988362.300362.30
5985466-985466359.918359.92
61013110-1013110370.014370.01
5min1240929-24092987.99484.362.8088.6284.972.78
2233656-23365685.33785.94
3231132-23113284.41585.03
4230118-23011884.04584.65
5228819-22881983.57184.17
6221172-22117280.77881.39
10min1250570-25057091.51590.781.2892.2991.531.28
2244670-24467089.36090.10
3253401-25340192.54993.31
4247752-24775290.48691.23
5245958-24595889.83090.57
6248957-24895790.92691.68
20min1249902-24990291.27190.401.2292.2091.301.21
2245558-24555889.68490.58
3248754-24875490.85191.76
4249206-24920691.01791.91
5242264-24226488.48189.37
6249367-24936791.07591.98
30min1239777-23977787.57389.911.5888.6590.961.55
2245881-24588189.80290.84
3248891-24889190.90291.96
4245386-24538689.62190.67
5245817-24581789.77990.82
6251245-25124591.76192.82
45min1244451-24445189.28089.740.9990.5090.940.98
2247816-24781690.50991.70
3247762-24776290.48991.70
4247978-24797890.56891.76
5242509-24250988.57189.76
6243736-24373689.01990.23
60min1248731-24873190.84389.781.4392.2291.141.43
2244409-24440989.26590.61
3249131-24913190.98992.35
4246672-24667290.09191.44
5239564-23956487.49588.83
6246423-24642390.00091.36
极限1236888-23688886.51888.592.0988.0490.092.06
2240746-24074687.92789.42
3247656-24765690.45091.97
4245772-24577289.76291.26
5236842-23684286.50187.98
6247416-24741690.36391.87
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
116.329393602939938894008159391210940602393982080.07
216.389440388945230094463440.09
单位质量响应值RSD%判断
575870.59576699.880.11数据可信
供试品溶液-25021101-2-1批-缬沙坦-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%
15min13999284-399928438.68538.265.0338.6838.265.04
24009142-400914238.78038.78
34102006-410200639.67839.68
43556732-355673234.40434.40
54039958-403995839.07839.08
64027846-402784638.96138.96
5min19145107-914510788.46086.761.4488.5286.831.43
28944577-894457786.52086.59
39054551-905455187.58487.65
49008695-900869587.14187.20
58785066-878506684.97785.04
68879465-887946585.89185.96
10min19662621-966262193.46692.570.8093.6892.780.80
29563939-956393992.51192.72
39622059-962205993.07493.29
49540241-954024192.28292.48
59441679-944167991.32991.54
69589002-958900292.75492.96
20min19709199-970919993.91793.110.7194.2893.470.71
29596721-959672192.82993.19
39673676-967367693.57393.94
49566348-956634892.53592.89
59538245-953824592.26392.62
69670503-967050393.54293.90
30min19713233-971323393.95693.200.6494.4893.720.64
29607455-960745592.93293.45
39687782-968778293.70994.23
49591075-959107592.77493.28
59554016-955401692.41692.93
69660021-966002193.44193.96
45min19727854-972785494.09793.460.6394.7894.140.64
29625581-962558193.10893.78
39734194-973419494.15894.84
49610901-961090192.96693.63
59594361-959436192.80693.47
69680205-968020593.63694.31
60min19755358-975535894.36394.100.9195.2094.930.90
29649450-964945093.33994.17
39881531-988153195.58496.42
49641853-964185393.26594.09
59706742-970674293.89394.71
69736497-973649794.18195.01
极限19785382-978538294.65493.900.5095.6594.890.50
29662876-966287693.46994.45
39731820-973182094.13595.13
49666586-966658693.50494.48
59675972-967597293.59594.57
69723320-972332094.05395.04
缬沙坦氨氯地平片项目信息
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100374-202106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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.972476602481832481552478672482312480190.10
213.942494052496602495320.08
单位质量响应值RSD%判断
17753.6917900.430.59数据可信
供试品溶液-25031806批-氨氯地平-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%
15min11032847-1032847375.584374.331.96375.58374.321.96
21037302-1037302377.204377.20
31031606-1031606375.133375.13
41016526-1016526369.649369.65
51058767-1058767385.009385.01
6999266-999266363.372363.37
5min1243168-24316888.42587.581.1189.0588.201.10
2237448-23744886.34586.97
3243063-24306388.38789.01
4240179-24017987.33987.95
5238034-23803486.55987.20
6243189-24318988.43389.04
10min1258841-25884194.12593.590.5894.9094.360.57
2254907-25490792.69493.47
3257969-25796993.80894.58
4256723-25672393.35594.12
5258685-25868594.06894.85
6257083-25708393.48694.24
20min1259331-25933194.30393.710.9195.2394.630.90
2257829-25782993.75794.68
3261068-26106894.93595.86
4254298-25429892.47393.39
5256735-25673593.35994.30
6256878-25687893.41194.32
30min1259182-25918294.24993.620.8295.3494.700.82
2256541-25654193.28894.37
3260864-26086494.86095.95
4256117-25611793.13494.21
5256454-25645493.25794.36
6255513-25551392.91593.98
45min1255437-25543792.88793.251.3294.1394.491.32
2254620-25462092.59093.83
3260978-26097894.90296.15
4256313-25631393.20694.43
5259586-25958694.39695.65
6251748-25174891.54592.76
60min1258292-25829293.92593.421.0795.3294.811.06
2256628-25662893.32094.71
3260477-26047794.72096.12
4253941-25394192.34393.72
5258523-25852394.00995.42
6253588-25358892.21593.59
极限1254724-25472492.62893.290.8694.1894.840.86
2256585-25658593.30494.85
3260436-26043694.70596.27
4255298-25529892.83694.37
5257474-25747493.62895.20
6254769-25476992.64494.17
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
116.329417194943306994330749423928943484594284220.09
216.389446010946615394560820.16
单位质量响应值RSD%判断
577721.94577294.380.06数据可信
供试品溶液-25031806批-缬沙坦-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%
15min13644986-364498635.18336.693.2335.1836.693.23
23715649-371564935.86535.87
33753201-375320136.22836.23
43807106-380710636.74836.75
53965044-396504438.27238.27
63921400-392140037.85137.85
5min18608794-860879483.09683.042.5183.1583.102.51
28585222-858522282.86982.93
38690793-869079383.88883.95
48279254-827925479.91579.98
58937873-893787386.27286.34
68517918-851791882.21982.28
10min19563290-956329092.30992.291.9592.5192.491.95
29483410-948341091.53891.74
39690217-969021793.53493.73
49282713-928271389.60189.80
59828654-982865494.87195.08
69520721-952072191.89892.10
20min19665959-966595993.30093.181.8193.6593.531.81
29554887-955488792.22892.58
39786262-978626294.46294.82
49396350-939635090.69891.04
59893564-989356495.49795.86
69621262-962126292.86993.22
30min19661831-966183193.26093.171.7693.7793.681.76
29553876-955387692.21892.72
39790143-979014394.49995.01
49408781-940878190.81891.31
59884534-988453495.41095.93
69618366-961836692.84193.35
45min19662417-966241793.26693.241.8893.9393.901.88
29563947-956394792.31692.97
39807682-980768294.66895.34
49381390-938139090.55491.20
59893255-989325595.49496.18
69646495-964649593.11293.78
60min19695828-969582893.58993.411.8694.4194.231.86
29575007-957500792.42293.23
39823064-982306494.81795.65
49388444-938844490.62291.42
59891439-989143995.47796.32
69690369-969036993.53694.35
极限19682297-968229793.45893.301.8594.4394.271.85
29565604-956560492.33293.30
39826054-982605494.84695.83
49385536-938553690.59491.54
59877418-987741895.34196.34
69655838-965583893.20394.18
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