坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.103734537410373703748837568374360.25
2 16.123829638243382700.10
单位质量响应值RSD%判断
2325.222374.071.48数据可信
供试品溶液-KF021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%
5min16648-664815.88521.4017.2815.8921.4017.28
29992-999223.87523.88
38504-850420.32020.32
47911-791118.90318.90
510813-1081325.83725.84
69859-985923.55823.56
10min118190-1819043.46456.9914.1343.4957.0314.13
226512-2651263.34963.39
322441-2244153.62253.66
423349-2334955.79155.82
527595-2759565.93765.98
625024-2502459.79459.83
15min128908-2890869.07485.4610.2069.1785.5910.21
238243-3824391.38091.53
334807-3480783.17083.29
436204-3620486.50886.63
538511-3851192.02092.17
637920-3792090.60890.75
20min135963-3596385.93296.975.8286.1597.255.84
241883-41883100.077100.38
340363-4036396.44596.71
441270-4127098.61398.88
541680-4168099.59299.90
642344-42344101.179101.47
30min140600-4060097.012101.122.1997.37101.552.22
242742-42742102.130102.59
342144-42144100.701101.12
442488-42488101.523101.96
542637-42637101.879102.35
643304-43304103.473103.93
45min141273-4127398.620101.351.5699.14101.951.59
242590-42590101.767102.40
342333-42333101.153101.74
442381-42381101.267101.87
542619-42619101.836102.48
643298-43298103.458104.09
60min141446-4144699.033101.511.4799.72102.281.50
242485-42485101.516102.32
342468-42468101.475102.23
442420-42420101.360102.13
542673-42673101.965102.78
643392-43392103.683104.49
极限142975-42975102.687102.340.79103.54103.280.79
242655-42655101.922102.90
342563-42563101.702102.63
442554-42554101.681102.62
542800-42800102.268103.25
643435-43435103.786104.76
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.103813437934381393799437944380290.27
2 16.123858838550385690.07
单位质量响应值RSD%判断
2362.052392.620.91数据可信
供试品溶液-KF021批-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14264-426410.06910.2313.7910.0710.2213.79
23955-39559.3409.34
33449-34498.1458.14
44965-496511.72511.72
55007-500711.82411.82
64342-434210.25310.25
10min115009-1500935.44333.5410.2835.4633.5610.28
214536-1453634.32634.34
311637-1163727.48027.49
415463-1546336.51536.53
515208-1520835.91335.93
613367-1336731.56631.58
15min126079-2607961.58557.9810.4061.6658.0510.40
227236-2723664.31764.39
320185-2018547.66647.73
425468-2546860.14260.22
525361-2536159.88959.97
622979-2297954.26454.33
20min134618-3461881.74977.228.7681.9377.398.76
235177-3517783.06983.25
327647-2764765.28765.43
433999-3399980.28780.47
533740-3374079.67679.86
631008-3100873.22473.38
30min140422-4042295.45593.364.9795.7793.664.98
241238-4123897.38297.70
335788-3578884.51284.76
440400-4040095.40395.72
540275-4027595.10895.42
639075-3907592.27492.56
45min142670-42670100.76499.312.63101.2499.762.66
243039-43039101.635102.12
340141-4014194.79195.18
442617-42617100.638101.11
542541-42541100.459100.93
641317-4131797.56998.00
60min142598-42598100.594100.371.75101.24100.991.77
243261-43261102.159102.81
341326-4132697.59098.14
443135-43135101.862102.50
542755-42755100.964101.60
641940-4194099.04099.64
极限142781-42781101.026100.651.06101.84101.441.03
242725-42725100.893101.71
343361-43361102.395103.10
442359-42359100.029100.84
542471-42471100.294101.10
642044-4204499.285100.05
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.103859038750385823870038548386340.23
2 16.123925638846390510.75
单位质量响应值RSD%判断
2399.632422.520.68数据可信
供试品溶液-KF021批-pH4.5(内含1.0%Tween)
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
10min12885-28856.7177.147.396.727.147.40
22998-29986.9806.98
33249-32497.5657.56
43032-30327.0607.06
53417-34177.9567.96
62819-28196.5646.56
15min16321-632114.71815.517.5414.7315.527.54
26554-655415.26015.27
36799-679915.83115.84
46319-631914.71314.72
57610-761017.71917.73
66353-635314.79214.80
20min110173-1017323.68724.558.1223.7224.598.12
210309-1030924.00324.04
310860-1086025.28625.33
49991-999123.26323.30
512130-1213028.24328.29
69807-980722.83422.87
30min117278-1727840.23040.544.6140.3040.624.61
217446-1744640.62140.70
317871-1787141.61041.69
416825-1682539.17539.25
518670-1867043.47143.56
616386-1638638.15338.23
45min125357-2535759.04158.172.7659.1858.312.77
225035-2503558.29158.44
325501-2550159.37659.53
424347-2434756.68956.83
525691-2569159.81859.98
623957-2395755.78155.92
60min130714-3071471.51469.802.1371.7570.052.13
230303-3030370.55770.80
330011-3001169.87770.13
429275-2927568.16368.40
530426-3042670.84371.11
629150-2915067.87268.10
极限132627-3262775.96875.681.2776.3376.041.28
232815-3281576.40676.77
332619-3261975.94976.32
432538-3253875.76176.11
532734-3273476.21776.60
631688-3168873.78174.12
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