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)1.5
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%
116.113822938147381393804838155381440.17
216.153843938812386260.69
单位质量响应值RSD%判断
2367.722391.700.72数据可信
长期3月-供试品溶液-2025030321批-含0.35%吐温20的pH6.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110679-1067925.19226.6916.7525.1926.6916.76
28509-850920.07320.07
312043-1204328.41028.41
410136-1013623.91123.91
512969-1296930.59530.59
613555-1355531.97731.98
10min124519-2451957.84263.1811.4857.8863.2211.48
222596-2259653.30553.34
330832-3083272.73572.78
425544-2554460.26060.30
528803-2880367.94868.00
628389-2838966.97167.02
15min133600-3360079.26582.963.1779.4083.113.19
234363-3436381.06481.19
336846-3684686.92287.09
435104-3510482.81382.95
535539-3553983.83984.00
635546-3554683.85584.02
20min137745-3774589.04389.891.0589.3190.181.04
238723-3872391.35091.61
338457-3845790.72391.04
437973-3797389.58189.86
537757-3775789.07189.38
637967-3796789.56789.87
30min138978-3897891.95292.431.8492.3792.871.83
240313-4031395.10195.51
339403-3940392.95493.42
439195-3919592.46392.89
538075-3807589.82190.27
639126-3912692.30192.75
45min139321-3932192.76193.021.5293.3393.621.50
240388-4038895.27895.85
339514-3951493.21693.84
439498-3949893.17893.76
538518-3851890.86691.47
639350-3935092.82993.44
60min139398-3939892.94293.081.8893.6793.821.86
240429-4042995.37596.10
339710-3971093.67894.45
439702-3970293.66094.40
538173-3817390.05390.81
639320-3932092.75893.52
极限139654-3965493.54693.341.7094.4394.241.68
240529-4052995.61096.50
339709-3970993.67694.61
439745-3974593.76194.65
538483-3848390.78491.69
639278-3927892.65993.58
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)1.5
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%
116.113840438308382253836838198383010.24
216.153834738277383120.13
单位质量响应值RSD%判断
2377.472372.260.16数据可信
长期3月-供试品溶液-2025030421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18734-873420.64623.4015.2720.6523.4015.27
211399-1139926.94526.95
39008-900821.29321.29
48544-854420.19720.20
59558-955822.59322.59
612149-1214928.71828.72
10min120813-2081349.19856.579.6149.2356.609.61
225670-2567060.67960.72
323451-2345155.43455.47
422691-2269153.63853.67
523596-2359655.77755.81
627362-2736264.67964.73
15min129557-2955769.86878.206.1369.9878.346.13
234360-3436081.22181.37
331982-3198275.60075.73
433380-3338078.90479.03
534126-3412680.66880.80
635099-3509982.96883.12
20min135596-3559684.14388.993.1484.3889.253.15
238263-3826390.44790.73
337114-3711487.73187.98
437878-3787889.53789.79
539030-3903092.26092.53
637992-3799289.80690.10
30min139235-3923592.74593.410.9493.1293.820.94
239724-3972493.90094.33
339527-3952793.43593.83
439517-3951793.41193.81
540076-4007694.73395.15
639013-3901392.22092.66
45min140136-4013694.87494.840.8595.4095.400.83
239947-3994794.42895.02
340476-4047695.67896.23
439842-3984294.17994.74
540568-4056895.89696.47
639752-3975293.96794.56
60min140273-4027395.19894.861.1795.8895.591.15
240156-4015694.92295.67
340554-4055495.86296.58
440014-4001494.58695.30
540518-4051895.77796.51
639273-3927392.83493.59
极限140395-4039595.48794.920.7496.3395.810.72
240229-4022995.09496.00
340181-4018194.98195.86
440149-4014994.90595.78
540388-4038895.47096.37
639594-3959493.59394.50
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)1.5
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%
116.113909639163391933911439314391760.23
216.153863238717386740.16
单位质量响应值RSD%判断
2431.782394.671.09数据可信
长期3月-供试品溶液-2025030422批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19929-992923.09921.5615.5923.1021.5615.60
28974-897420.87720.88
37881-788118.33418.33
49697-969722.55922.56
511519-1151926.79826.80
67613-761317.71117.71
10min123575-2357554.84449.5410.9654.8849.5710.95
221892-2189250.92950.96
319423-1942345.18545.22
422277-2227751.82551.86
523049-2304953.62153.67
617542-1754240.80940.84
15min133143-3314377.10371.228.1377.2371.348.14
232352-3235275.26375.38
328563-2856366.44866.55
431743-3174373.84673.97
531231-3123172.65572.79
626654-2665462.00762.10
20min137675-3767587.64684.233.8087.9084.473.81
237110-3711086.33286.58
335316-3531682.15882.37
436847-3684785.72085.97
536371-3637184.61384.87
633920-3392078.91179.11
30min140844-4084495.01992.991.9995.4293.371.99
239675-3967592.29992.69
340744-4074494.78695.14
439266-3926691.34891.74
540366-4036693.90794.30
638948-3894890.60890.94
45min141053-4105395.50594.641.7896.0795.171.78
240394-4039493.97294.51
341278-4127896.02896.54
439662-3966292.26992.81
541536-4153696.62897.18
640161-4016193.43093.91
60min141269-4126996.00795.131.7796.7395.821.77
240577-4057794.39795.10
341561-4156196.68797.36
439696-3969692.34893.04
541566-4156696.69897.41
640679-4067994.63595.27
极限141222-4122295.89895.581.8096.7896.421.79
240574-4057494.39095.25
341677-4167796.95697.79
439855-3985592.71893.57
541794-4179497.22998.10
641379-4137996.26397.06
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