枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.452401782400892399922399662397102399870.08
217.592389322387462388390.06
单位质量响应值RSD%判断
13752.8413578.110.91数据可信
供试品溶液-2024051611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%
5min1181898-18189867.40169.432.0667.4069.432.06
2186136-18613668.97268.97
3192413-19241371.29871.30
4184738-18473868.45468.45
5190194-19019470.47570.48
6188910-18891070.00070.00
10min1188626-18862669.89471.562.0570.0171.672.05
2192023-19202371.15371.27
3198957-19895773.72273.84
4189177-18917770.09970.21
5195472-19547272.43172.55
6194406-19440672.03672.15
15min1188513-18851369.85271.841.9270.0872.081.92
2193576-19357671.72971.96
3198745-19874573.64473.89
4191064-19106470.79871.03
5196583-19658372.84373.08
6194849-19484972.20072.44
20min1189174-18917470.09771.881.9870.4472.231.98
2192560-19256071.35271.71
3199236-19923673.82674.19
4190743-19074370.67971.03
5196967-19696772.98573.34
6195178-19517872.32272.68
30min1190117-19011770.44772.281.8470.9172.761.84
2194561-19456172.09472.57
3200319-20031974.22774.71
4192530-19253071.34171.81
5197266-19726673.09673.58
6195606-19560672.48172.96
45min1190840-19084070.71572.432.0371.2973.032.03
2194873-19487372.20972.80
3200905-20090574.44475.06
4191219-19121970.85571.44
5198126-19812673.41574.02
6196871-19687172.94973.55
极限1194263-19426371.98372.891.8072.6873.611.80
2193822-19382271.82072.53
3201011-20101174.48475.22
4192652-19265271.38672.09
5199381-19938173.88074.60
6199190-19919073.80974.53
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.452394732395832395692394532398012395760.06
217.592392312387802390060.14
单位质量响应值RSD%判断
13729.2813587.610.74数据可信
供试品溶液-2024051611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%
5min1191950-19195071.16271.401.2671.1671.401.26
2188139-18813969.74969.75
3194399-19439972.07072.07
4193203-19320371.62671.63
5193129-19312971.59971.60
6194812-19481272.22372.22
10min1196308-19630872.77773.191.1872.9073.311.18
2193833-19383371.86071.98
3198604-19860473.62873.75
4197786-19778673.32573.44
5197299-19729973.14573.26
6200759-20075974.42774.55
15min1197003-19700373.03572.752.4073.2772.992.39
2187558-18755869.53369.77
3196640-19664072.90073.14
4197626-19762673.26673.51
5196739-19673972.93773.18
6201879-20187974.84375.09
20min1197019-19701973.04173.180.8573.4073.540.85
2194444-19444472.08672.44
3198617-19861773.63374.00
4198048-19804873.42273.79
5197137-19713773.08573.45
6199121-19912173.82074.19
30min1197809-19780973.33473.710.9973.8274.200.99
2195679-19567972.54473.02
3199238-19923873.86474.35
4199324-19932473.89574.38
5199321-19932173.89474.38
6201586-20158674.73475.23
45min1199168-19916873.83873.800.9074.4474.400.91
2196212-19621272.74273.33
3199001-19900173.77674.39
4198843-19884373.71774.33
5199264-19926473.87374.48
6201855-20185574.83475.45
极限1200555-20055574.35274.250.6575.0874.970.65
2198570-19857073.61674.33
3199475-19947573.95174.68
4199775-19977574.06374.79
5200960-20096074.50275.23
6202277-20227774.99075.73
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.452386012384492385702388862388712386750.09
217.592387342388192387760.03
单位质量响应值RSD%判断
13677.6513574.530.54数据可信
供试品溶液-2024051612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%
5min1173413-17341364.44165.200.9164.4465.200.91
2175074-17507465.05865.06
3177562-17756265.98365.98
4175819-17581965.33565.34
5174090-17409064.69364.69
6176771-17677165.68965.69
10min1178011-17801166.15065.761.7466.2665.871.74
2175112-17511265.07365.18
3180693-18069367.14767.26
4172277-17227764.01964.13
5179495-17949566.70166.81
6176214-17621465.48265.59
15min1179740-17974066.79266.880.7667.0167.100.76
2180722-18072267.15767.37
3182254-18225467.72767.95
4179322-17932266.63766.85
5179555-17955566.72466.94
6178299-17829966.25766.48
20min1181508-18150867.44967.130.6967.7867.460.70
2179763-17976366.80167.13
3182751-18275167.91168.25
4179663-17966366.76467.09
5179731-17973166.78967.12
6180524-18052467.08467.41
30min1182257-18225767.72867.511.1668.1767.951.16
2180476-18047667.06667.51
3183792-18379268.29868.75
4181823-18182367.56668.00
5183522-18352268.19868.64
6178154-17815466.20366.64
45min1184615-18461568.60468.801.0169.1669.351.00
2183442-18344268.16868.72
3188251-18825169.95570.52
4183256-18325668.09968.65
5186028-18602869.12969.68
6185182-18518268.81569.37
极限1187250-18725069.58369.630.7470.2570.300.73
2186892-18689269.45070.12
3189231-18923170.31971.00
4188011-18801169.86670.53
5187828-18782869.79870.47
6185116-18511668.79069.46
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.452407512407672414922411072405522409340.16
217.592389662392402391030.09
单位质量响应值RSD%判断
13807.1113593.121.11数据可信
供试品溶液-2024051612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%
5min1176419-17641965.20765.542.2265.2165.542.22
2174803-17480364.61064.61
3177435-17743565.58365.58
4174192-17419264.38464.38
5184986-18498668.37468.37
6176091-17609165.08665.09
10min1180608-18060866.75567.402.0266.8667.512.02
2177544-17754465.62365.73
3181588-18158867.11867.23
4181601-18160167.12267.23
5188374-18837469.62669.74
6184378-18437868.14968.26
15min1181454-18145467.06867.552.0967.2967.782.09
2179388-17938866.30566.52
3182731-18273167.54067.76
4185356-18535668.51068.73
5188872-18887269.81070.04
6178814-17881466.09266.31
20min1182142-18214267.32268.141.8867.6568.471.88
2179735-17973566.43366.76
3184189-18418968.07968.41
4184610-18461068.23568.57
5190056-19005670.24870.59
6185347-18534768.50768.84
30min1184212-18421268.08868.202.3868.5368.652.37
2180111-18011166.57267.01
3184657-18465768.25268.70
4187036-18703669.13169.58
5191393-19139370.74271.21
6179753-17975366.43966.89
45min1185651-18565168.61968.551.0969.1869.111.08
2182755-18275567.54968.10
3185914-18591468.71769.28
4183419-18341967.79468.36
5187320-18732069.23669.82
6187675-18767569.36869.92
极限1187902-18790269.45169.331.8870.1270.011.88
2181744-18174467.17567.84
3186116-18611668.79169.47
4188363-18836369.62270.30
5192419-19241971.12171.82
6188923-18892369.82970.50
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.452393292385112391332389522387372389320.14
217.592390292393722392000.11
单位质量响应值RSD%判断
13692.3813598.640.49数据可信
供试品溶液-2024051613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%
5min1178728-17872866.32263.763.4766.3263.763.47
2167605-16760562.19462.19
3167832-16783262.27862.28
4166123-16612361.64461.64
5179737-17973766.69666.70
6170956-17095663.43863.44
10min1183179-18317967.97365.613.7868.0865.713.78
2171739-17173963.72863.83
3173444-17344464.36164.46
4168267-16826762.44062.54
5184966-18496668.63668.75
6179237-17923766.51166.62
15min1184481-18448168.45666.563.1168.6866.773.11
2175410-17541065.09065.30
3175385-17538565.08165.29
4173415-17341564.35064.56
5187191-18719169.46269.69
6180265-18026566.89267.11
20min1184141-18414168.33066.743.0568.6767.073.06
2176917-17691765.65065.97
3176895-17689565.64165.96
4172254-17225463.91964.23
5187147-18714769.44669.79
6181777-18177767.45367.78
30min1188161-18816169.82267.542.8670.2767.982.86
2177431-17743165.84066.27
3179170-17917066.48666.91
4176156-17615665.36765.79
5187631-18763169.62570.08
6183512-18351268.09768.54
45min1188444-18844469.92768.072.6370.5068.622.64
2179019-17901966.43066.97
3181224-18122467.24867.79
4178109-17810966.09266.62
5189598-18959870.35570.93
6184178-18417868.34468.90
极限1187740-18774069.66669.401.5070.3570.061.51
2185303-18530368.76169.41
3185679-18567968.90169.55
4183536-18353668.10668.75
5191429-19142971.03571.73
6188435-18843569.92470.59
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.452401012404912403242399812402742402340.09
217.592397412398952398180.05
单位质量响应值RSD%判断
13766.9913633.770.69数据可信
供试品溶液-2024051613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%
5min1176898-17689865.38065.862.1565.3865.862.15
2176490-17649065.23065.23
3176287-17628765.15565.15
4184854-18485468.32168.32
5180452-18045266.69466.69
6174236-17423664.39764.40
10min1181255-18125566.99167.912.1967.1068.022.19
2181544-18154467.09867.21
3182216-18221667.34667.45
4189734-18973470.12570.24
5187787-18778769.40569.52
6179880-17988066.48366.59
15min1185054-18505468.39568.532.4068.6268.762.40
2182119-18211967.31067.53
3183935-18393567.98168.20
4192030-19203070.97371.20
5189259-18925969.94970.18
6180200-18020066.60166.82
20min1185298-18529868.48568.861.9168.8269.191.91
2183657-18365767.87968.21
3185369-18536968.51168.85
4191430-19143070.75171.10
5189745-18974570.12970.47
6182314-18231467.38267.71
30min1185439-18543968.53769.302.0568.9969.762.05
2186046-18604668.76269.21
3186614-18661468.97169.42
4193040-19304071.34671.81
5191163-19116370.65371.11
6182780-18278067.55468.00
45min1188124-18812469.53069.821.6270.0970.391.62
2188745-18874569.75970.32
3186631-18663168.97869.54
4192534-19253471.15971.75
5192433-19243371.12271.70
6185023-18502368.38368.94
极限1189979-18997970.21570.531.1170.8971.221.12
2190877-19087770.54771.22
3189968-18996870.21170.89
4192175-19217571.02771.73
5194081-19408171.73172.43
6187943-18794369.46370.13
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