坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091748621739071758781748671748531748730.40
216.051740631742111741370.07
单位质量响应值RSD%判断
10868.4310849.660.13数据可信
长期3月-供试品溶液-12235763批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119746-1974610.20814.5516.4410.2114.5516.44
228241-2824114.60014.60
332802-3280216.95816.96
429491-2949115.24615.25
527011-2701113.96413.96
631549-3154916.31016.31
10min150821-5082126.27336.5216.1326.3936.6816.12
271206-7120636.81136.97
382721-8272142.76442.95
475574-7557439.06939.24
565325-6532533.77133.93
678191-7819140.42240.60
15min184736-8473643.80659.2315.8844.2159.8015.87
2112072-11207257.93758.51
3131167-13116767.80968.47
4123440-12344063.81464.42
5104236-10423653.88654.42
6131770-13177068.12168.75
20min1115101-11510159.50376.8712.9960.4078.1013.03
2151010-15101078.06779.28
3166711-16671186.18487.60
4165237-16523785.42286.73
5139068-13906871.89373.02
6155070-15507080.16681.55
30min1161316-16131683.39593.265.5384.9595.345.70
2186860-18686096.60098.68
3186317-18631796.32098.69
4187615-18761596.99199.25
5178766-17876692.41694.34
6181486-18148693.82296.10
45min1177353-17735391.68595.982.5494.1799.102.73
2189397-18939797.912101.07
3187160-18716096.755100.20
4189594-18959498.014101.35
5187457-18745796.90999.86
6182995-18299594.60297.92
60min1180463-18046393.29395.841.4696.79100.021.70
2188609-18860997.504101.75
3185659-18565995.979100.50
4186545-18654596.437100.87
5185962-18596296.136100.17
6185083-18508395.682100.05
极限1180810-18081093.47395.051.2298.01100.301.40
2183422-18342294.823100.15
3181896-18189694.03499.62
4185955-18595596.132101.63
5184689-18468995.478100.58
6186412-18641296.369101.80
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091758711747021753911761631751481754550.33
216.051758211770231764220.49
单位质量响应值RSD%判断
10904.6010992.020.57数据可信
加速3月-供试品溶液-12235763批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118087-180879.2749.3911.259.279.3911.27
220563-2056310.54410.54
319947-1994710.22810.23
419482-194829.9909.99
516290-162908.3538.35
615492-154927.9447.94
10min161302-6130231.43328.6110.4131.5428.7210.40
260043-6004330.78830.90
355670-5567028.54528.66
456950-5695029.20229.31
544891-4489123.01823.11
655970-5597028.69928.79
15min1114425-11442558.67251.0212.6559.1251.4412.62
2107014-10701454.87255.33
396919-9691949.69650.13
496253-9625349.35549.79
577819-7781939.90240.25
6104556-10455653.61254.02
20min1159450-15945081.75970.8512.7382.8671.8412.69
2145681-14568174.69975.77
3134356-13435668.89269.88
4131514-13151467.43568.42
5108909-10890955.84456.64
6149194-14919476.50077.50
30min1188546-18854696.67989.577.2398.6991.347.32
2178430-17843091.49193.39
3177213-17721390.86792.62
4172020-17202088.20589.94
5151362-15136277.61279.02
6180491-18049192.54894.40
45min1193544-19354499.24195.962.17102.3398.732.33
2183969-18396994.33297.25
3186128-18612895.43998.20
4188734-18873496.77599.49
5182026-18202693.33595.61
6188421-18842196.61499.50
60min1190303-19030397.57996.211.23101.77100.041.21
2183769-18376994.22998.19
3189059-18905996.942100.76
4186682-18668295.72399.51
5188702-18870296.759100.07
6187227-18722796.00299.96
极限1187868-18786896.33195.051.32101.6099.951.43
2181952-18195293.29798.31
3187322-18732296.051100.95
4184332-18433294.51899.37
5183479-18347994.08098.47
6187222-18722296.000101.02
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