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%
115.951716921722681716331709091722701717540.33
216.071719181719861719520.03
单位质量响应值RSD%判断
10768.2810700.190.45数据可信
供试品溶液-12407637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%
5min119099-190999.9887.4618.199.997.4618.21
214207-142077.4307.43
311366-113665.9445.94
413151-131516.8786.88
514259-142597.4577.46
613482-134827.0517.05
10min156703-5670329.65524.0614.4129.7724.1414.42
249636-4963625.95926.04
338573-3857320.17320.24
446502-4650224.32024.40
544388-4438823.21423.30
640199-4019921.02321.10
15min198411-9841151.46743.5913.8151.9143.9413.81
292529-9252948.39148.76
372367-7236737.84738.14
488370-8837046.21646.56
578520-7852041.06541.41
669857-6985736.53436.85
20min1136151-13615171.20461.2713.1272.2262.1113.12
2130752-13075268.38169.29
3104159-10415954.47355.18
4123739-12373964.71365.57
5110405-11040557.74058.54
697746-9774651.11951.84
30min1167856-16785687.78683.816.1989.5985.326.29
2169283-16928388.53290.20
3152561-15256179.78781.10
4167032-16703287.35588.93
5160203-16020383.78385.22
6144565-14456575.60576.89
45min1181472-18147294.90795.011.9197.6997.462.02
2182887-18288795.64798.30
3176827-17682792.47794.68
4185280-18528096.89899.45
5185096-18509696.80299.17
6178500-17850093.35295.48
60min1184981-18498196.74296.311.75100.5899.821.84
2182643-18264395.51999.23
3179420-17942093.83397.06
4188581-18858198.624102.25
5186434-18643497.502100.95
6182905-18290595.65698.82
极限1174212-17421291.11095.262.4996.0299.832.29
2184129-18412996.296101.07
3180794-18079494.55298.82
4186812-18681297.699102.42
5181440-18144094.89099.42
6185490-18549097.008101.23
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%
115.951710921729311727351710321724041720390.53
216.071703431704621704020.05
单位质量响应值RSD%判断
10786.1410603.731.21数据可信
供试品溶液-12407637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%
5min115929-159298.3628.2317.168.368.2317.16
215988-159888.3938.39
312383-123836.5006.50
415669-156698.2258.23
513747-137477.2167.22
620303-2030310.65810.66
10min146433-4643324.37424.9013.0024.4724.9913.00
247743-4774325.06225.16
337797-3779719.84119.91
446643-4664324.48524.58
548903-4890325.67125.75
657084-5708429.96530.08
15min182300-8230043.20244.0012.9743.5744.3612.97
284272-8427244.23744.61
367114-6711435.23135.52
479565-7956541.76742.13
589888-8988847.18547.55
699747-9974752.36152.81
20min1116401-11640161.10361.8312.8261.9562.6812.81
2117759-11775961.81662.68
395195-9519549.97150.66
4109974-10997457.72958.56
5128177-12817767.28568.17
6139174-13917473.05774.09
30min1147899-14789977.63882.008.1779.1683.558.24
2159046-15904683.48985.04
3137392-13739272.12273.36
4153738-15373880.70382.17
5166783-16678387.55089.19
6172450-17245090.52592.37
45min1175656-17565692.20892.803.8594.5995.253.99
2179271-17927194.10696.58
3163680-16368085.92287.96
4178988-17898893.95796.32
5182257-18225795.67398.28
6180857-18085794.93897.79
60min1181399-18139995.22394.552.4398.6398.032.63
2182071-18207195.57699.10
3171686-17168690.12493.12
4179261-17926194.10197.51
5183241-18324196.19099.86
6183021-18302196.07499.98
极限1180288-18028894.64095.211.4299.1199.741.51
2182259-18225995.674100.26
3179045-17904593.98797.98
4180828-18082894.92399.38
5186094-18609497.687102.43
6179698-17969894.33099.30
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