坎地沙坦酯片项目信息
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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.0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%
116.091854451854261855071854141854831854550.03
216.031854981855921855450.04
单位质量响应值RSD%判断
11526.1011574.860.30数据可信
供试品溶液-24121701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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0001.1150.110.001.1150.12
22739-27391.3341.33
32759-27591.3441.34
42443-24431.1901.19
53163-31631.5401.54
62594-25941.2631.26
15min16066-60662.9543.367.142.953.387.30
26761-67613.2933.31
37043-70433.4303.44
47448-74483.6273.64
57317-73173.5633.58
66818-68183.3203.33
20min18819-88194.2954.424.354.334.474.35
28616-86164.1964.25
38938-89384.3534.41
49713-97134.7304.78
59340-93404.5494.61
69005-90054.3854.44
30min110392-103925.0615.284.755.145.384.79
210643-106435.1835.28
310719-107195.2205.32
411857-118575.7745.88
510819-108195.2695.38
610643-106435.1835.28
45min111078-110785.3955.624.865.535.784.83
211823-118235.7585.91
311419-114195.5615.72
412251-122515.9666.14
510771-107715.2455.41
611950-119505.8205.98
60min111771-117715.7325.863.985.936.083.95
212146-121465.9156.13
311916-119165.8036.02
412820-128206.2436.48
511386-113865.5455.77
612125-121255.9056.13
120min112075-120755.8806.142.756.146.432.84
212493-124936.0846.37
313005-130056.3336.62
412983-129836.3236.63
512544-125446.1096.39
612596-125966.1346.42
240min112344-123446.0116.314.376.346.664.34
213201-132016.4296.78
313014-130146.3386.69
413900-139006.7697.15
512786-127866.2276.58
612467-124676.0716.43
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限112693-126936.1816.374.986.576.794.87
212860-128606.2636.69
312862-128626.2646.69
414400-144007.0137.46
512869-128696.2676.69
612788-127886.2286.65
坎地沙坦酯片项目信息
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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.0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%
116.091853931855361852861855181850531853570.11
216.031855531856241855880.03
单位质量响应值RSD%判断
11520.0111577.540.36数据可信
供试品溶液-24121702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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13478-34781.6941.4850.391.691.4850.38
24238-42382.0642.06
3-0.0000.00
43539-35391.7241.72
53838-38381.8691.87
63181-31811.5491.55
15min17401-74013.6053.505.513.623.525.67
27553-75533.6793.70
36508-65083.1703.17
47083-70833.4503.47
57541-75413.6733.69
67090-70903.4533.47
20min19375-93754.5664.553.824.634.613.99
29303-93034.5314.60
38786-87864.2794.31
49461-94614.6084.67
59896-98964.8204.88
69278-92784.5194.57
30min110977-109775.3475.322.305.465.432.18
210758-107585.2405.35
311104-111045.4085.49
410568-105685.1475.26
511271-112715.4905.60
610865-108655.2925.40
45min111616-116165.6585.792.035.835.951.88
211744-117445.7205.89
312082-120825.8856.03
411944-119445.8185.98
511679-116795.6885.86
612217-122175.9516.12
60min112659-126596.1666.111.986.406.341.87
212772-127726.2216.46
312766-127666.2186.43
412290-122905.9866.22
512560-125606.1186.36
612188-121885.9366.17
120min113112-131126.3866.352.636.696.652.48
213327-133276.4916.80
313304-133046.4806.76
412438-124386.0586.36
512824-128246.2466.55
613183-131836.4216.72
240min113047-130476.3556.412.236.736.782.22
213144-131446.4026.78
312878-128786.2726.62
413204-132046.4316.80
513717-137176.6817.06
613005-130056.3346.70
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限113093-130936.3776.461.856.826.901.69
213095-130956.3786.83
313607-136076.6287.05
413069-130696.3656.80
513542-135426.5967.05
613178-131786.4196.86
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