缬沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.131213611195961209431207421207161206720.55
214.101200051199281199660.05
单位质量响应值RSD%判断
8540.138508.230.27数据可信
供试品溶液-2024082021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%
5min150751-5075137.59136.666.9337.5936.666.94
253557-5355739.66939.67
348059-4805935.59735.60
450629-5062937.50137.50
543464-4346432.19432.19
650505-5050537.40937.41
10min196608-9660871.55769.132.7971.6269.192.80
294063-9406369.67269.74
392470-9247068.49268.55
492893-9289368.80568.87
588985-8898565.91165.96
694983-9498370.35370.42
15min1116637-11663786.39282.673.0886.5782.843.08
2110137-11013781.57881.76
3112044-11204482.99083.16
4111850-11185082.84783.02
5106172-10617278.64178.80
6112829-11282983.57283.75
20min1124115-12411591.93188.282.3792.2688.592.37
2116890-11689086.58086.90
3119488-11948888.50488.82
4117154-11715486.77587.09
5117049-11704986.69886.99
6120381-12038189.16689.48
30min1130077-13007796.34793.252.0196.8393.712.01
2122740-12274090.91391.38
3124067-12406791.89692.36
4126935-12693594.02094.48
5125680-12568093.09193.53
6125878-12587893.23793.70
45min1132920-13292098.45394.502.4099.0995.122.40
2124958-12495892.55693.17
3126520-12652093.71394.33
4129515-12951595.93196.55
5125486-12548692.94793.54
6126115-12611593.41394.04
60min1132819-13281998.37895.442.0399.1896.212.03
2126655-12665593.81394.58
3128033-12803394.83395.60
4130898-13089896.95697.73
5125943-12594393.28594.03
6128728-12872895.34896.13
极限1138576-138576102.643100.392.42103.61101.332.40
2132204-13220497.92398.85
3131844-13184497.65698.58
4139241-139241103.135104.07
5137367-137367101.747102.65
6134012-13401299.262100.20
缬沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.131202111200891199601198941199161200140.12
214.101200681204911202800.25
单位质量响应值RSD%判断
8493.568530.500.31数据可信
供试品溶液-AV0080F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%
5min14175062-41750623096.8673140.061.393096.873140.061.39
24337595-43375953217.4263217.43
34222439-42224393132.0093132.01
44261531-42615313161.0063161.01
54198665-41986653114.3743114.37
64204500-42045003118.7033118.70
10min15004956-50049563712.4443746.470.683717.613751.700.68
25035608-50356083735.1803740.54
35040203-50402033738.5883743.81
45049368-50493683745.3863750.65
55069690-50696903760.4603765.65
65105116-51051163786.7383791.94
15min15108754-51087543789.4363809.720.703800.793821.200.70
25117208-51172083795.7073807.29
35180184-51801843842.4203853.87
45150054-51500543820.0713831.58
55091418-50914183776.5773788.04
65168998-51689983834.1223845.63
20min15091435-50914353776.5903815.550.793794.253833.380.78
25124298-51242983800.9663818.88
35191502-51915023850.8153868.67
45163310-51633103829.9033847.78
55112779-51127793792.4223810.17
65180459-51804593842.6243860.52
30min15111939-51119393791.7993823.180.693815.763847.360.68
25129481-51294813804.8113829.06
35197818-51978183855.5003879.77
45165987-51659873831.8893856.15
55131432-51314323806.2583830.33
65188813-51888133848.8203873.12
45min15129621-51296213804.9143832.650.783835.193863.210.78
25133438-51334383807.7463838.34
35206233-52062333861.7423892.44
45153572-51535723822.6803853.33
55152477-51524773821.8683852.28
65226730-52267303876.9453907.66
60min15116626-51166263795.2753834.310.773831.903871.260.76
25141083-51410833813.4163850.35
35210013-52100133864.5453901.68
45187693-51876933847.9893885.01
55148882-51488823819.2013855.99
65211235-52112353865.4523902.63
极限15154362-51543623823.2663873.950.803866.213917.280.79
25189754-51897543849.5183892.81
35245218-52452183890.6593934.23
45238020-52380203885.3203928.75
55250446-52504463894.5373937.69
65258315-52583153900.3743944.00
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