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%
115.951710101729661734821733471731981728010.59
216.071703331710821707080.32
单位质量响应值RSD%判断
10833.9210622.781.40数据可信
供试品溶液-12235763批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111292-112925.9096.5910.965.916.5910.97
211638-116386.0906.09
312396-123966.4876.49
411931-119316.2446.24
513290-132906.9556.95
615031-150317.8667.87
10min140111-4011120.99123.209.8621.0623.289.86
240717-4071721.30821.38
341945-4194521.95022.02
444701-4470123.39323.46
547049-4704924.62124.70
651504-5150426.95327.04
15min174437-7443738.95442.1110.0139.2542.4410.01
273804-7380438.62338.93
374469-7446938.97139.29
480833-8083342.30142.63
585255-8525544.61544.97
694042-9404249.21349.60
20min1107150-10715056.07359.118.3556.8059.918.37
2106096-10609655.52256.26
3104238-10423854.54955.30
4112095-11209558.66159.46
5119620-11962062.59963.45
6128536-12853667.26568.20
30min1151603-15160379.33681.736.0280.6983.196.05
2145309-14530976.04277.39
3146700-14670076.77078.13
4163151-16315185.37986.83
5164258-16425885.95987.50
6166065-16606586.90488.59
45min1174202-17420291.16292.522.7793.4094.882.87
2174203-17420391.16393.36
3169667-16966788.78991.00
4181443-18144394.95297.35
5179092-17909293.72196.22
6182131-18213195.31297.96
60min1163137-16313785.37292.174.2888.6295.564.27
2180228-18022894.31697.52
3170925-17092589.44792.64
4179139-17913993.74697.20
5181431-18143194.94598.48
6181910-18191095.19698.90
极限1178820-17882093.57994.131.6997.7898.541.58
2186007-18600797.340101.60
3178028-17802893.16597.35
4178365-17836593.34197.84
5178736-17873693.53598.13
6179258-17925893.80898.57
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%
115.951713511724111721751723151718451720190.26
216.071715711724251719980.36
单位质量响应值RSD%判断
10784.8910703.050.54数据可信
供试品溶液-12235763批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113464-134647.0356.947.777.046.947.75
213411-134117.0077.01
312020-120206.2816.28
412614-126146.5916.59
513103-131036.8466.85
615069-150697.8747.87
10min147141-4714124.63222.617.0424.7122.687.03
241956-4195621.92222.00
340086-4008620.94521.02
444034-4403423.00823.08
540114-4011420.96021.04
646266-4626624.17424.26
15min186884-8688445.39840.637.8645.7540.967.84
274201-7420138.77139.09
373540-7354038.42538.73
481534-8153442.60242.93
570436-7043636.80437.11
679956-7995641.77842.13
20min1122226-12222663.86457.228.0164.7258.007.99
2103892-10389254.28555.04
3103262-10326253.95554.68
4115216-11521660.20261.00
599256-9925651.86252.58
6113252-11325259.17560.00
30min1163053-16305385.19780.145.8886.7681.565.89
2151416-15141679.11680.47
3141968-14196874.18075.51
4160788-16078884.01385.48
5143910-14391075.19476.49
6159135-15913583.15084.63
45min1183002-18300295.62092.193.8298.1394.503.87
2175587-17558791.74693.98
3164879-16487986.15188.30
4181040-18104094.59597.00
5173395-17339590.60192.73
6180751-18075194.44496.85
60min1178259-17825993.14293.962.5296.7297.292.54
2180295-18029594.20697.46
3171731-17173189.73192.84
4182629-18262995.42598.88
5181314-18131494.73897.87
6184763-18476396.54199.99
极限1182801-18280195.51594.921.39100.1399.301.48
2179178-17917893.62297.92
3178086-17808693.05297.16
4184808-18480896.564101.08
5182826-18282695.52899.72
6182265-18226595.23599.76
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