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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
112.113833963834533830063829273827383831040.09
212.143837823828633833220.17
单位质量响应值RSD%判断
31635.3431575.120.14数据可信
供试品溶液-2024072521批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1399796-39979695.88192.657.5895.8892.657.58
2346398-34639883.07583.08
3362282-36228286.88486.88
4377842-37784290.61690.62
5408272-40827297.91497.91
6423414-423414101.546101.55
10min1405378-40537897.22095.985.1897.3896.145.18
2371745-37174589.15489.29
3383746-38374692.03292.18
4397302-39730295.28395.43
5414117-41411799.31699.48
6429065-429065102.901103.07
15min1406424-40642497.47196.994.0397.7997.304.04
2382849-38284991.81792.10
3391839-39183993.97394.27
4402751-40275196.59096.90
5413416-41341699.14899.48
6429153-429153102.922103.26
20min1407296-40729697.68097.753.5998.1698.233.60
2389361-38936193.37993.82
3396332-39633295.05195.51
4404943-40494397.11697.59
5417686-417686100.172100.67
6429917-429917103.105103.62
30min1406608-40660897.51598.032.7198.1698.672.73
2397427-39742795.31395.91
3401402-40140296.26696.88
4405868-40586897.33897.97
5412307-41230798.88299.54
6428878-428878102.856103.54
45min1406540-40654097.49998.272.3298.3199.072.34
2401719-40171996.34297.10
3404492-40449297.00897.78
4406375-40637597.45998.25
5411301-41130198.64199.47
6428043-428043102.656103.51
60min1405640-40564097.28398.222.2698.2599.182.28
2402116-40211696.43897.35
3405022-40502297.13598.07
4406348-40634897.45398.41
5410604-41060498.47399.46
6427595-427595102.548103.57
极限1405277-40527797.19698.092.1898.3399.222.20
2403547-40354796.78197.86
3404719-40471997.06298.16
4404286-40428696.95898.08
5409633-40963398.24099.39
6426677-426677102.328103.53
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
112.113835773835243837053824053830913832600.14
212.143828723829743829230.02
单位质量响应值RSD%判断
31648.2231542.260.24数据可信
供试品溶液-2024072521批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1314854-31485475.53489.157.7775.5389.167.77
2383809-38380992.07792.08
3369005-36900588.52588.53
4389027-38902793.32893.33
5382112-38211291.66991.67
6390942-39094293.78893.79
10min1355763-35576385.34895.025.7185.4795.175.71
2400684-40068496.12596.28
3398810-39881095.67595.82
4425126-425126101.989102.14
5393195-39319594.32894.48
6402878-40287896.65196.81
15min1375563-37556390.09897.114.6590.3797.424.66
2407552-40755297.77298.09
3406669-40666997.56197.87
4434387-434387104.210104.54
5399594-39959495.86396.17
6404930-40493097.14397.46
20min1385123-38512392.39298.074.2292.8198.544.23
2410077-41007798.37898.85
3409549-40954998.25298.72
4438502-438502105.197105.70
5402665-40266596.60097.07
6406865-40686597.60898.09
30min1393153-39315394.31898.993.9494.8999.623.95
2412935-41293599.06499.70
3415866-41586699.767100.40
4441701-441701105.965106.64
5406460-40646097.51198.14
6405747-40574797.33997.98
45min1402509-40250996.56399.673.5397.29100.463.54
2413684-41368499.244100.05
3420183-420183100.803101.60
4442538-442538106.166107.02
5407236-40723697.69798.49
6406579-40657997.53998.34
60min1413377-41337799.170100.063.18100.06101.023.18
2413629-41362999.230100.20
3420903-420903100.975101.94
4441613-441613105.944106.97
5408440-40844097.98698.94
6404476-40447697.03598.00
极限1409435-40943598.224100.233.3599.28101.363.35
2421929-421929101.222102.36
3422403-422403101.335102.47
4441635-441635105.949107.15
5408020-40802097.88599.00
6403448-40344896.78897.92
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
112.113833113839023830833831313829823832820.10
212.143830203831963831080.04
单位质量响应值RSD%判断
31650.0431557.500.21数据可信
供试品溶液-2024072522批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1387696-38769692.98489.683.7492.9889.683.74
2374388-37438889.79289.79
3387394-38739492.91192.91
4349483-34948383.81983.82
5372998-37299889.45989.46
6371600-37160089.12389.12
10min1409878-40987898.30496.983.4298.4697.133.42
2425398-425398102.026102.18
3408159-40815997.89298.05
4386313-38631392.65292.79
5404016-40401696.89897.05
6392460-39246094.12694.27
15min1412281-41228198.88097.621.9299.2097.931.92
2409733-40973398.26998.59
3414077-41407799.31199.63
4395044-39504494.74695.04
5411429-41142998.67698.99
6399530-39953095.82296.13
20min1411408-41140898.67198.211.5699.1598.681.56
2411324-41132498.65199.13
3417085-417085100.032100.52
4400436-40043696.03996.49
5413479-41347999.16899.64
6403165-40316596.69497.16
30min1415599-41559999.67699.391.64100.32100.031.65
2415413-41541399.631100.28
3424297-424297101.762102.41
4405983-40598397.37097.98
5417737-417737100.189100.83
6407450-40745097.72298.35
45min1413401-41340199.14999.711.6399.96100.511.63
2415564-41556499.668100.48
3428362-428362102.737103.56
4408948-40894898.08198.86
5416436-41643699.877100.68
6411682-41168298.73799.53
60min1412369-41236998.90199.781.6399.88100.751.62
2415359-41535999.618100.60
3428503-428503102.771103.76
4410147-41014798.36899.31
5418187-418187100.297101.27
6411728-41172898.74899.70
极限1411978-41197898.80899.771.5099.95100.911.50
2415333-41533399.612100.76
3428140-428140102.684103.85
4411187-41118798.61899.72
5416050-41605099.784100.93
6413358-41335899.139100.26
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
112.113831033829953834343830713836303832470.08
212.143848953844273846610.09
单位质量响应值RSD%判断
31647.1531685.420.09数据可信
供试品溶液-2024072522批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1357248-35724885.51289.667.9385.5189.667.93
2399188-39918895.55195.55
3380294-38029491.02891.03
4417929-417929100.037100.04
5347941-34794183.28483.28
6344952-34495282.56982.57
10min1403590-40359096.60597.882.8296.7598.032.83
2412248-41224898.67798.84
3404379-40437996.79396.95
4427852-427852102.412102.58
5411851-41185198.58298.72
6393507-39350794.19194.33
15min1408386-40838697.75399.282.2498.0699.592.24
2412161-41216198.65698.98
3411223-41122398.43298.74
4430950-430950103.154103.49
5420022-420022100.538100.84
6405832-40583297.14197.44
20min1409121-40912197.92899.822.0898.39100.302.09
2413502-41350298.97799.47
3413497-41349798.97699.45
4432023-432023103.410103.92
5422557-422557101.145101.62
6411395-41139598.47398.93
30min1409723-40972398.073100.141.9798.70100.781.97
2412457-41245798.72799.38
3415688-41568899.500100.14
4431864-431864103.372104.05
5424242-424242101.548102.19
6416120-41612099.604100.22
45min1410628-41062898.289100.411.9299.08101.231.92
2411666-41166698.53899.36
3422582-422582101.151101.96
4431120-431120103.194104.05
5424721-424721101.663102.47
6416322-41632299.652100.44
60min1409937-40993798.124100.101.8399.08101.081.83
2411695-41169598.54599.53
3417307-41730799.888100.86
4430122-430122102.955103.98
5423952-423952101.478102.46
6416071-41607199.592100.54
极限1409072-40907297.91799.951.8999.04101.091.89
2410739-41073998.31699.46
3416521-41652199.700100.84
4429474-429474102.800104.00
5424156-424156101.527102.67
6415361-41536199.422100.54
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