阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.141035101036291028571031621025411031400.44
210.121033361032301032830.08
单位质量响应值RSD%判断
10171.6010205.830.24数据可信
长期24月-供试品溶液-2023111721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%
5min148173-4817342.42550.5215.6342.4350.5215.63
270625-7062562.19862.20
355752-5575249.10049.10
450524-5052444.49644.50
553141-5314146.80046.80
665983-6598358.11058.11
10min181603-8160371.86674.444.5872.1074.724.62
287700-8770077.23677.58
382226-8222672.41572.69
480655-8065571.03171.28
584428-8442874.35474.61
690525-9052579.72480.05
15min190824-9082479.98783.376.6180.6284.076.60
294488-9448883.21483.99
387242-8724276.83377.51
492671-9267181.61482.26
597481-9748185.85086.52
6105317-10531792.75193.52
20min193423-9342382.27687.624.8983.3688.784.91
2101762-10176289.62090.86
394325-9432583.07084.17
499269-9926987.42588.52
5102160-10216089.97191.12
6105999-10599993.35194.63
30min1100270-10027088.30692.503.6489.8494.153.67
2108006-10800695.11996.85
3100769-10076988.74690.31
4105864-10586493.23394.81
5105576-10557692.97994.63
6109739-10973996.64598.44
45min1100310-10031088.34194.174.7290.3796.334.72
2114804-114804101.106103.37
3104087-10408791.66893.72
4107102-10710294.32396.42
5105171-10517192.62294.79
6110108-11010896.97099.31
60min1101888-10188889.73193.523.0792.2596.203.12
2110865-11086597.637100.46
3104223-10422391.78794.35
4106395-10639593.70096.32
5104890-10489092.37595.06
6108860-10886095.87198.75
极限1110622-11062297.42398.260.91100.44101.460.86
2111804-11180498.464101.83
3113378-11337899.850102.93
4111785-11178598.447101.59
5111126-11112697.867101.06
6110748-11074897.534100.94
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.141031531031841027721025811023671028110.35
210.121033001031021032010.14
单位质量响应值RSD%判断
10139.1510197.730.41数据可信
长期24月-供试品溶液-2023111821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%
5min161011-6101153.83951.116.3853.8451.106.38
253794-5379447.47047.47
355944-5594449.36749.37
459994-5999452.94152.94
562434-6243455.09455.09
654309-5430947.92547.92
10min189840-8984079.27974.146.4879.5874.426.46
279401-7940170.06770.33
385607-8560775.54375.82
490684-9068480.02480.32
578696-7869669.44569.75
679850-7985070.46370.73
15min194389-9438983.29381.284.0484.0381.984.02
294193-9419383.12083.77
393110-9311082.16482.86
495588-9558884.35185.09
585792-8579275.70776.40
689568-8956879.03979.70
20min196472-9647285.13185.385.5786.3386.525.52
2102532-10253290.47991.59
394943-9494383.78284.93
4101399-10139989.47990.69
587485-8748577.20178.31
697687-9768786.20387.30
30min198275-9827586.72288.204.3188.4089.824.26
2105959-10595993.50395.12
399295-9929587.62289.24
4102110-10211090.10691.81
593054-9305482.11583.66
6101021-10102189.14590.72
45min199125-9912587.47289.554.5689.6391.664.50
2108259-10825995.53297.67
3100441-10044188.63490.74
4104368-10436892.09994.30
594730-9473083.59485.59
6101959-10195989.97392.04
60min198597-9859787.00690.155.3189.6592.765.22
2110609-11060997.606100.27
3104681-10468192.37594.97
4102572-10257290.51493.23
594655-9465583.52885.99
6101828-10182889.85792.43
极限1108467-10846795.71697.431.1798.84100.541.18
2112160-11216098.975102.18
3110710-11071097.695100.80
4111227-11122798.152101.37
5110261-11026197.299100.23
6109614-10961496.72899.80
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.141027031028881025561029891035461029360.37
210.121027681042421035051.01
单位质量响应值RSD%判断
10151.4810227.770.53数据可信
长期24月-供试品溶液-2023111921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%
5min148434-4843442.65240.8610.7342.6540.8610.73
238880-3888034.23834.24
343609-4360938.40338.40
444526-4452639.21039.21
551275-5127545.15345.15
651704-5170445.53145.53
10min193920-9392082.70772.4311.3582.9472.6611.33
266655-6665558.69758.89
389323-8932378.65978.87
481726-8172671.96972.19
579860-7986070.32670.58
682026-8202672.23372.49
15min1101017-10101788.95783.258.2989.6583.888.29
280281-8028170.69771.21
3102298-10229890.08590.74
494716-9471683.40884.03
593726-9372682.53683.18
695150-9515083.79084.44
20min1103523-10352391.16488.005.9992.3589.096.02
289420-8942078.74579.65
3107133-10713394.34395.49
4100168-10016888.20989.29
598344-9834486.60387.70
6101000-10100088.94290.06
30min1110284-11028497.11894.553.8098.8196.133.86
299595-9959587.70589.05
3111005-11100597.75399.43
4107437-10743794.61196.18
5107886-10788695.00696.59
6108022-10802295.12696.74
45min1113853-113853100.26197.472.47102.5099.582.52
2107206-10720694.40796.24
3111045-11104597.788100.01
4109254-10925496.21198.31
5113806-113806100.219102.33
6108934-10893495.92998.07
60min1113524-11352499.97197.901.32102.76100.541.35
2110299-11029997.13199.49
3109472-10947296.40399.16
4112253-11225398.852101.48
5110639-11063997.430100.10
6110815-11081597.585100.26
极限1110416-11041697.23495.981.14100.5899.181.09
2109583-10958396.50099.40
3106964-10696494.19497.49
4108216-10821695.29798.48
5109711-10971196.61399.82
6109091-10909196.06799.28
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