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%
1 11.997556107558607563577558047548127556890.08
2 11.957544827544387544600.01
单位质量响应值RSD%判断
63026.6163134.730.13数据可信
供试品溶液-2024073021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1744769-74476989.11589.344.0289.1289.344.01
2773742-77374292.58292.58
3762631-76263191.25391.25
4705438-70543884.40984.41
10min1684375-68437581.88993.048.1982.0493.198.17
2821402-82140298.28598.44
3789660-78966094.48794.64
4814848-81484897.50197.64
15min1805984-80598496.44094.276.0296.7394.576.00
2773948-77394892.60792.92
3729946-72994687.34287.65
4841435-841435100.682100.99
20min1813745-81374597.36997.512.1197.8197.972.10
2830434-83043499.36699.84
3824200-82420098.62099.07
4791300-79130094.68395.15
30min1748467-74846789.55897.325.4290.1797.955.39
2843607-843607100.942101.58
3824129-82412998.61199.23
4837319-837319100.189100.82
45min1832853-83285399.65597.194.24100.4197.974.20
2806711-80671196.52797.33
3766121-76612191.67092.45
4843273-843273100.902101.70
60min1831469-83146999.48999.971.04100.41100.911.03
2843399-843399100.917101.88
3841779-841779100.723101.66
4825188-82518898.73899.70
极限1785145-78514593.94799.093.5295.04100.213.49
2843900-843900100.977102.11
3835865-835865100.015101.12
4847678-847678101.429102.56
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%
1 11.997572067566627547677569497562187563600.13
2 11.957569387559217564300.10
单位质量响应值RSD%判断
63082.5763299.580.25数据可信
供试品溶液-2024073021批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1810857-81085796.85488.597.0296.8588.587.02
2714909-71490985.39385.39
3749731-74973189.55389.55
4691051-69105182.54382.54
10min1747630-74763089.30292.866.1689.4693.006.15
2742098-74209888.64188.78
3846098-846098101.063101.21
4773844-77384492.43392.57
15min1801484-80148495.73494.242.2196.0494.542.21
2768997-76899791.85492.14
3779946-77994693.16293.48
4805523-80552396.21796.51
20min1850762-850762101.62097.243.36102.0997.693.36
2797332-79733295.23895.68
3818349-81834997.74998.22
4789749-78974994.33394.78
30min1799118-79911895.45298.332.9096.0998.952.88
2829272-82927299.05399.66
3853748-853748101.977102.61
4810764-81076496.84397.45
45min1823992-82399298.42397.731.8899.2298.511.86
2801921-80192195.78696.55
3810089-81008996.76297.57
4836703-83670399.941100.71
60min1855096-855096102.13899.412.06103.10100.362.05
2823834-82383498.40499.33
3834463-83446399.673100.64
4815558-81555897.41598.35
极限1817979-81797997.70499.881.8198.84100.991.79
2841891-841891100.561101.65
3853429-853429101.939103.07
4831371-83137199.304100.40
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%
1 11.997559877563527554807567567553017559750.08
2 11.957549147546397547760.03
单位质量响应值RSD%判断
63050.4663161.170.13数据可信
供试品溶液-2024073021批-pH3.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1798835-79883595.54695.272.3695.5595.272.36
2771317-77131792.25592.26
3816794-81679497.69597.69
4799228-79922895.59495.59
10min1767688-76768891.82192.6810.1391.9892.8410.11
2666547-66654779.72479.88
3829981-82998199.27299.43
4835202-83520299.896100.06
15min1833756-83375699.72396.245.50100.0496.555.47
2829862-82986299.25899.54
3815383-81538397.52697.85
4739399-73939988.43888.76
20min1829077-82907799.16499.530.4499.64100.000.45
2828883-82888399.14099.59
3834928-83492899.863100.35
4835666-83566699.952100.42
30min1825443-82544398.72997.404.4499.3798.044.43
2760613-76061390.97591.59
3834364-83436499.796100.45
4836799-836799100.087100.73
45min1832417-83241799.56397.633.87100.3798.433.84
2836477-836477100.049100.82
3826852-82685298.89899.72
4769233-76923392.00692.81
60min1833760-83376099.724100.290.38100.70101.250.37
2840115-840115100.484101.42
3840326-840326100.509101.50
4839698-839698100.434101.39
极限1829663-82966399.23498.343.21100.3799.463.19
2783179-78317993.67494.78
3835286-83528699.906101.06
4840480-840480100.528101.65
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