盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.997540797535257553117534737555827543940.14
211.957524987531797528380.07
单位质量响应值RSD%判断
62918.6062999.000.10数据可信
供试品溶液-2024073021批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1777830-77783093.25195.592.0493.2595.592.04
2814679-81467997.66997.67
3805656-80565696.58796.59
4791044-79104494.83694.84
10min1662119-66211979.37991.1510.6379.5391.3110.62
2726091-72609187.04987.21
3827455-82745599.20199.36
4825610-82561098.98099.14
15min1826727-82672799.11395.066.1699.4095.376.13
2824278-82427898.82099.13
3722259-72225986.58986.92
4798324-79832495.70896.03
20min1839845-839845100.68699.560.76101.14100.040.75
2828164-82816499.28699.76
3827558-82755899.21399.68
4826401-82640199.07499.56
30min1753247-75324790.30496.734.7190.9297.374.69
2808621-80862196.94397.58
3840059-840059100.712101.35
4825588-82558898.97799.62
45min1823215-82321598.69296.903.1599.4697.703.11
2828872-82887299.371100.17
3772335-77233592.59393.40
4808564-80856496.93697.75
60min1843856-843856101.167100.150.69102.10101.100.67
2833867-83386799.969100.93
3832507-83250799.806100.76
4831291-83129199.661100.63
90min1791896-79189694.93898.142.5896.0499.272.56
2815310-81531097.74598.88
3842604-842604101.017102.14
4824732-82473298.874100.01
120min1835686-835686100.18898.611.63101.4599.901.60
2829172-82917299.407100.70
3804686-80468696.47197.76
4820712-82071298.39299.70
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1838925-838925100.57699.870.72102.01101.330.70
2825164-82516498.926100.39
3836167-836167100.245101.70
4831996-83199699.745101.21
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.997533027541247525117544807525487533930.12
211.957548507548577548540.01
单位质量响应值RSD%判断
62835.1163167.700.38数据可信
供试品溶液-2024073021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%
5min1449098-44909853.80550.517.7253.8050.527.71
2432660-43266051.83551.84
3374505-37450544.86844.87
4430267-43026751.54951.55
10min1265056-26505631.75545.2536.0231.8545.3335.94
2255609-25560930.62430.71
3481251-48125157.65757.73
4508752-50875260.95261.04
15min1444193-44419353.21749.7716.2053.3649.9216.10
2496849-49684959.52659.66
3364026-36402643.61343.78
4356486-35648642.70942.90
20min1546042-54604265.41963.316.2265.6563.556.20
2547807-54780765.63165.87
3479333-47933357.42757.67
4540447-54044764.74965.01
30min1408907-40890748.99059.0219.7649.3359.3719.65
2408003-40800348.88149.23
3572368-57236868.57368.91
4581379-58137969.65370.02
45min1507885-50788560.84858.6312.9561.2759.0812.81
2571029-57102968.41368.84
3440077-44007752.72453.18
4438416-43841652.52553.01
60min1607536-60753672.78771.406.3673.3171.946.31
2624084-62408474.76975.31
3540116-54011664.70965.25
4612012-61201273.32373.89
90min1483040-48304057.87168.2716.4658.5268.9416.31
2494580-49458059.25459.92
3646999-64699977.51578.16
4654763-65476378.44579.14
120min1569625-56962568.24568.818.7568.9969.598.64
2646301-64630177.43178.20
3533483-53348363.91564.69
4547956-54795665.64966.47
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1668328-66832880.07077.727.5280.9278.617.44
2683998-68399881.94782.84
3576558-57655869.07569.96
4666029-66602979.79480.73
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