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%
112.233834713832503839893840803834683836520.10
212.243829243829523829380.01
单位质量响应值RSD%判断
31369.7531285.780.19数据可信
供试品溶液-6021201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%
5min1118195-11819528.47736.4338.2428.4836.4338.24
256005-5600513.49413.49
3203398-20339849.00549.01
4183049-18304944.10344.10
5142897-14289734.42934.43
6203649-20364949.06649.07
10min1157318-15731837.90347.4435.7837.9547.5035.79
275993-7599318.30918.33
3255416-25541661.53861.62
4237377-23737757.19257.27
5198767-19876747.89047.95
6256599-25659961.82361.91
15min1181207-18120743.65955.3330.9743.7755.4730.98
2110433-11043326.60726.66
3289543-28954369.76169.94
4272645-27264565.68965.86
5237592-23759257.24457.38
6286453-28645369.01669.20
20min1199381-19938148.03861.7326.7248.2261.9626.75
2147085-14708535.43835.54
3314504-31450475.77576.08
4300555-30055572.41472.69
5266367-26636764.17764.41
6309372-30937274.53874.84
30min1222116-22211653.51570.4821.5053.7870.8121.54
2204865-20486549.35949.52
3347170-34717083.64584.07
4334966-33496680.70581.10
5307451-30745174.07574.41
6338486-33848681.55381.98
45min1244992-24499259.02777.8917.0459.3878.3417.10
2261992-26199263.12363.36
3370346-37034689.22989.80
4360828-36082886.93687.47
5342247-34224782.45982.92
6359233-35923386.55187.11
60min1267212-26721264.38082.2113.6564.8382.7913.72
2299315-29931572.11572.46
3381259-38125991.85892.57
4372303-37230389.70090.38
5358859-35885986.46187.06
6368256-36825688.72589.43
90min1298266-29826671.86287.359.6272.4288.079.69
2346285-34628583.43283.90
3387793-38779393.43394.30
4384418-38441892.61993.45
5378230-37823091.12891.87
6380390-38039091.64992.50
120min1322649-32264977.73790.357.1178.4291.217.18
2374747-37474790.28990.89
3396669-39666995.57196.59
4389053-38905393.73694.72
5383518-38351892.40393.30
6383272-38327292.34393.35
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1369537-36953789.03494.523.1989.8495.543.31
2390123-39012393.99494.75
3405854-40585497.78498.97
4400312-40031296.44997.59
5395429-39542995.27296.32
6392582-39258294.58695.75
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%
112.233832453829873824253829713827193828690.09
212.243835123837753836440.05
单位质量响应值RSD%判断
31305.7231343.460.09数据可信
供试品溶液-6021301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%
5min1219012-21901252.77341.5021.5052.7741.5021.50
2162665-16266539.19539.20
3200052-20005248.20448.20
4186601-18660144.96344.96
5117663-11766328.35228.35
6147396-14739635.51635.52
10min1263568-26356863.50953.8412.6563.6053.9112.66
2214922-21492251.78751.85
3240506-24050657.95258.03
4232465-23246556.01456.09
5183018-18301844.10044.15
6206147-20614749.67349.73
15min1292923-29292370.58262.259.3070.7862.409.32
2254900-25490061.42061.57
3271408-27140865.39865.57
4265092-26509263.87664.04
5223986-22398653.97154.09
6241691-24169158.23758.38
20min1317592-31759276.52668.297.7176.8468.557.74
2283233-28323368.24768.50
3295878-29587871.29471.58
4281880-28188067.92168.20
5255968-25596861.67861.89
6265870-26587064.06464.30
30min1341633-34163382.31976.644.8982.7677.024.93
2318782-31878276.81377.18
3326114-32611478.58078.98
4318759-31875976.80877.20
5297038-29703871.57471.89
6306014-30601473.73774.08
45min1373764-37376490.06183.224.6990.6483.734.72
2345757-34575783.31383.81
3350734-35073484.51285.05
4341617-34161782.31582.83
5329846-32984679.47979.91
6330574-33057479.65480.12
60min1385111-38511192.79686.104.3593.5286.744.37
2356100-35610085.80586.44
3362364-36236487.31587.99
4353417-35341785.15985.81
5344587-34458783.03183.60
6342254-34225482.46983.07
90min1400257-40025796.44589.324.4997.3390.114.52
2371062-37106289.41090.19
3374591-37459190.26191.08
4367936-36793688.65789.45
5353384-35338485.15185.85
6356990-35699086.02086.76
120min1405919-40591997.80990.634.3098.8591.574.33
2373371-37337189.96790.89
3379288-37928891.39292.37
4373442-37344289.98490.93
5365272-36527288.01588.86
6359516-35951686.62887.51
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1413198-41319899.56393.693.53100.7794.783.56
2389811-38981193.92895.00
3392899-39289994.67295.80
4381956-38195692.03593.13
5381314-38131491.88192.87
6373802-37380290.07191.10
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%
112.233843583843153837233839493839413840570.08
212.243853173852573852870.02
单位质量响应值RSD%判断
31402.8631477.700.17数据可信
供试品溶液-6021401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%
5min1200687-20068748.17947.946.0348.1847.946.03
2205677-20567749.37749.38
3177982-17798242.72842.73
4198354-19835447.61947.62
5201129-20112948.28548.29
6214271-21427151.44051.44
10min1245276-24527658.88458.654.9658.9658.734.96
2250333-25033360.09860.18
3223853-22385353.74153.81
4242428-24242858.20058.28
5243133-24313358.36958.45
6260771-26077162.60462.69
15min1274707-27470765.94966.623.7866.1366.793.79
2284959-28495968.41168.59
3261251-26125162.71962.88
4276298-27629866.33166.51
5275483-27548366.13666.31
6292210-29221070.15170.34
20min1297337-29733771.38272.463.2871.6772.743.28
2306860-30686073.66873.96
3289301-28930169.45369.72
4300874-30087472.23172.52
5298190-29819071.58771.87
6318311-31831176.41776.72
30min1328839-32883978.94580.663.1279.3581.073.12
2341757-34175782.04682.47
3327182-32718278.54778.93
4334622-33462280.33380.74
5329185-32918579.02879.44
6354384-35438485.07885.51
45min1350866-35086684.23386.212.8284.7786.752.82
2360843-36084386.62887.18
3354734-35473485.16285.67
4357901-35790185.92286.46
5352023-35202384.51185.05
6378281-37828190.81591.39
60min1361684-36168486.83089.022.8387.5189.702.83
2372316-37231689.38390.08
3367576-36757688.24588.90
4369439-36943988.69289.38
5363122-36312287.17587.86
6390573-39057393.76694.49
90min1374538-37453889.91691.502.1490.7492.332.15
2382551-38255191.84092.69
3381217-38121791.51992.32
4381753-38175391.64892.48
5371567-37156789.20390.03
6395066-39506694.84495.73
120min1379841-37984191.18992.932.3692.1693.912.36
2385101-38510192.45293.45
3385782-38578292.61593.57
4389699-38969993.55694.54
5378433-37843390.85191.82
6403642-40364296.90397.94
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1386840-38684092.86994.721.8994.0095.861.89
2394695-39469594.75595.91
3394460-39446094.69995.81
4397725-39772595.48396.62
5386851-38685192.87294.00
6406665-40666597.62998.83
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