他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.584764434776104753864755934759974762060.19
212.584775154789254782200.21
单位质量响应值RSD%判断
37854.2138014.310.30数据可信
长期24月-供试品溶液-2022031901批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299099-29909963.03338.8337.7163.0338.8337.71
2114172-11417224.06124.06
3199825-19982542.11242.11
4176103-17610337.11337.11
5204942-20494243.19043.19
6111454-11145423.48823.49
10min1466514-46651498.31577.3923.0498.4477.4623.05
2265080-26508055.86455.91
3399248-39924884.13984.22
4362965-36296576.49376.57
5438718-43871892.45792.54
6270674-27067457.04357.09
15min1480365-480365101.23490.5111.18101.5690.7411.22
2359792-35979275.82475.98
3457404-45740496.39596.65
4423213-42321389.19089.42
5468295-46829598.69198.96
6387671-38767181.70081.86
20min1483163-483163101.82495.606.14102.3596.026.20
2410334-41033486.47686.79
3470944-47094499.24999.69
4451010-45101095.04895.45
5473451-47345199.777100.25
6432980-43298091.24891.57
30min1486739-486739102.57899.023.36103.3199.623.43
2441725-44172593.09193.58
3479234-479234100.996101.64
4469875-46987599.02499.62
5477028-477028100.531101.20
6464491-46449197.88998.40
45min1486949-486949102.622100.502.17103.56101.302.23
2457356-45735696.38597.06
3482427-482427101.669102.51
4475030-475030100.110100.90
5479439-479439101.039101.91
6479981-479981101.153101.86
极限1489255-489255103.108101.281.55104.25102.281.63
2469690-46969098.98599.85
3487380-487380102.713103.76
4481355-481355101.443102.44
5481233-481233101.417102.49
6474587-474587100.017100.92
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.584765934771754759264782514773544770600.19
212.584806474783184794820.35
单位质量响应值RSD%判断
37922.1038114.630.36数据可信
长期24月-供试品溶液-2022032001批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116426-11642624.48230.1948.4524.4830.2048.45
2276730-27673058.19058.19
3158638-15863833.35833.36
498541-9854120.72120.72
588440-8844018.59718.60
6122776-12277625.81725.82
10min1271819-27181957.15865.6329.0757.2165.6929.09
2454476-45447695.56795.68
3390490-39049082.11282.18
4239549-23954950.37250.41
5226327-22632747.59247.63
6289942-28994260.96961.02
15min1383629-38362980.66985.0513.6180.8385.2413.66
2486586-486586102.319102.63
3457547-45754796.21296.44
4370607-37060777.93178.07
5344733-34473372.49072.62
6383739-38373980.69280.87
20min1426162-42616289.61392.407.9389.9492.767.99
2489262-489262102.881103.39
3473317-47331799.52899.95
4422748-42274888.89589.19
5396234-39623483.32083.60
6428648-42864890.13690.47
30min1458928-45892896.50398.283.6097.0198.823.69
2491693-491693103.393104.11
3482447-482447101.448102.07
4456538-45653896.00096.48
5447201-44720194.03794.48
6467329-46732998.26998.78
45min1473565-47356599.581100.431.97100.28101.172.05
2489809-489809102.996103.92
3485567-485567102.104102.93
4471309-47130999.10699.77
5464885-46488597.75598.39
6480458-480458101.030101.74
极限1482477-482477101.455102.100.75102.35103.050.85
2491940-491940103.444104.58
3486780-486780102.359103.39
4485307-485307102.050102.92
5481993-481993101.353102.18
6484803-484803101.944102.86
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.584756634753104763934749054761194756780.13
212.584807964800724804340.11
单位质量响应值RSD%判断
37812.2438190.300.71数据可信
长期24月-供试品溶液-2022032101批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1282217-28221759.37239.2648.8159.3739.2648.82
2179894-17989437.84637.85
3130503-13050327.45527.45
4110136-11013623.17023.17
5102785-10278521.62421.62
6314179-31417966.09666.10
10min1461969-46196997.18874.3226.2997.3174.4026.31
2383486-38348680.67780.75
3288501-28850160.69460.75
4282616-28261659.45659.50
5248582-24858252.29652.34
6454438-45443895.60395.74
15min1475581-475581100.05189.1211.41100.3689.3411.46
2460960-46096096.97597.21
3388576-38857681.74781.92
4377803-37780379.48179.65
5373415-37341578.55878.71
6465260-46526097.88098.20
20min1478809-478809100.73094.706.21101.2495.116.28
2476786-476786100.305100.74
3428948-42894890.24190.58
4418031-41803187.94488.27
5428042-42804290.05090.36
6470313-47031398.94399.46
30min1483485-483485101.71498.003.75102.4398.603.82
2483124-483124101.638102.27
3458874-45887496.53797.06
4437607-43760792.06292.56
5460131-46013196.80197.29
6471857-47185799.26899.98
45min1482208-482208101.44699.133.00102.3699.923.05
2486245-486245102.295103.13
3466550-46655098.15198.86
4446285-44628593.88894.57
5473050-47305099.519100.20
6472964-47296499.501100.42
极限1482499-482499101.50799.942.76102.63100.932.78
2486849-486849102.422103.46
3474240-47424099.769100.68
4450666-45066694.81095.68
5482917-482917101.595102.47
6473233-47323399.557100.67
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