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%
112.113988693985063985023989353981433985910.09
212.053981113978193979650.06
单位质量响应值RSD%判断
32914.2033026.140.25数据可信
供试品溶液-6021401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%
5min1424962-42496297.28796.161.7197.2996.161.71
2423939-42393997.05397.05
3416237-41623795.29095.29
4419534-41953496.04596.04
5407981-40798193.40093.40
6427576-42757697.88697.89
10min1428491-42849198.09597.281.2598.2697.441.25
2427703-42770397.91598.08
3421621-42162196.52396.68
4425519-42551997.41597.58
5416002-41600295.23695.39
6430301-43030198.51098.67
15min1427815-42781597.94197.091.1698.2797.421.16
2426920-42692097.73698.06
3420571-42057196.28296.60
4424277-42427797.13197.45
5416174-41617495.27695.59
6428896-42889698.18898.52
20min1427242-42724297.80997.001.2998.3097.481.29
2426123-42612397.55398.04
3419951-41995196.14096.62
4424303-42430397.13797.62
5414810-41481094.96395.44
6429730-42973098.37998.87
30min1426878-42687897.72696.841.2898.3897.491.28
2426076-42607697.54298.19
3419821-41982196.11196.75
4422375-42237596.69597.34
5414225-41422594.82995.46
6428755-42875598.15698.81
45min1425244-42524497.35296.641.1898.1797.451.18
2425079-42507997.31498.13
3418495-41849595.80796.61
4422187-42218796.65297.46
5414212-41421294.82695.62
6427522-42752297.87498.69
60min1424919-42491997.27896.471.1798.2597.441.17
2424118-42411897.09498.07
3416715-41671595.39996.36
4421270-42127096.44297.41
5414399-41439994.86995.82
6426845-42684597.71998.70
极限1434713-43471399.52096.621.85100.6697.741.84
2423122-42312296.86698.00
3416582-41658295.36996.49
4420351-42035196.23297.36
5412149-41214994.35495.46
6425249-42524997.35398.50
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%
112.113987453990023993303993153994603991700.08
212.053983573985573984570.04
单位质量响应值RSD%判断
32962.0133066.970.23数据可信
供试品溶液-6021401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%
5min1412866-41286694.39197.042.5594.3997.042.55
2423448-42344896.81196.81
3422679-42267996.63596.63
4444765-444765101.684101.68
5424037-42403796.94596.95
6418826-41882695.75495.75
10min1417651-41765195.48597.661.5795.6497.821.57
2427781-42778197.80197.96
3426512-42651297.51197.67
4437148-43714899.943100.11
5430974-43097498.53198.69
6423007-42300796.71096.87
15min1417060-41706095.35097.511.5995.6797.841.59
2427069-42706997.63997.96
3425017-42501797.16997.49
4436854-43685499.876100.21
5430427-43042798.40698.73
6422699-42269996.63996.96
20min1416079-41607995.12697.561.7295.6098.041.72
2433468-43346899.10299.59
3423832-42383296.89897.38
4435406-43540699.545100.05
5429183-42918398.12298.61
6422319-42231996.55397.03
30min1415044-41504494.88997.061.6195.5297.711.61
2424989-42498997.16397.82
3423205-42320596.75597.40
4435325-43532599.526100.19
5427912-42791297.83198.48
6420866-42086696.22096.86
45min1414405-41440594.74396.941.6195.5497.761.60
2424916-42491697.14697.96
3423765-42376596.88397.69
4434151-43415199.258100.09
5427591-42759197.75898.57
6419387-41938795.88296.69
60min1413245-41324594.47896.711.6195.4397.691.61
2423368-42336896.79297.77
3421706-42170696.41297.38
4433552-43355299.121100.12
5426401-42640197.48698.47
6419825-41982595.98296.95
极限1413550-41355094.54896.541.4695.6697.681.46
2423175-42317596.74897.89
3421078-42107896.26997.40
4431540-43154098.66199.83
5425554-42555497.29298.43
6418711-41871195.72896.85
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%
112.113976783977353973693977513971343975330.07
212.053983053982313982680.02
单位质量响应值RSD%判断
32826.8433051.290.49数据可信
供试品溶液-6021401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%
5min1412674-41267494.56493.054.4094.5693.054.40
2400541-40054191.78491.78
3407836-40783693.45693.46
4396504-39650490.85990.86
5382949-38294987.75387.75
6435890-43589099.88499.88
10min1424499-42449997.27497.473.5797.4397.633.57
2423605-42360597.06997.22
3416562-41656295.45595.61
4415577-41557795.23095.38
5416627-41662795.47095.62
6455358-455358104.345104.51
15min1426603-42660397.75698.802.3198.0899.122.31
2439048-439048100.608100.92
3429636-42963698.45198.77
4420584-42058496.37796.69
5424192-42419297.20497.51
6446865-446865102.399102.74
20min1427909-42790998.05698.852.9998.5499.332.99
2433353-43335399.30399.79
3419134-41913496.04596.52
4423103-42310396.95497.42
5429073-42907398.32298.79
6455634-455634104.409104.92
30min1426356-42635697.70099.221.6998.3599.871.70
2436760-436760100.084100.73
3430776-43077698.71299.35
4424446-42444697.26297.89
5435537-43553799.803100.43
6444155-444155101.778102.46
45min1425637-42563797.53599.582.3698.34100.392.35
2440406-440406100.919101.73
3418435-41843595.88596.69
4439298-439298100.665101.46
5438518-438518100.487101.28
6445117-445117101.999102.85
60min1425245-42524597.44599.032.5498.42100.012.53
2440600-440600100.964101.95
3417537-41753795.67996.64
4425259-42525997.44898.41
5439237-439237100.651101.62
6445161-445161102.009103.03
极限1424573-42457397.29199.092.8598.42100.232.84
2439835-439835100.788101.94
3415706-41570695.25996.38
4424939-42493997.37598.50
5446027-446027102.207103.34
6443409-443409101.607102.80
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%
112.113992543993603988973983903973783986560.21
212.054003154003224003180.01
单位质量响应值RSD%判断
32919.5733221.410.65数据可信
供试品溶液-6021401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%
5min1390694-39069489.17391.505.7389.1791.505.73
2411678-41167893.96293.96
3396093-39609390.40590.40
4416685-41668595.10595.10
5362942-36294282.83982.84
6427345-42734597.53897.54
10min1420945-42094596.07795.982.4796.2396.142.47
2422862-42286296.51596.67
3412062-41206294.05094.20
4429104-42910497.93998.10
5405299-40529992.50692.64
6432913-43291398.80998.97
15min1425458-42545897.10797.132.0497.4297.452.05
2425491-42549197.11597.43
3425789-42578997.18397.49
4431773-43177398.54998.87
5409877-40987793.55193.84
6435064-43506499.30099.63
20min1427209-42720997.50797.051.8097.9897.531.80
2425193-42519397.04797.53
3420536-42053695.98496.45
4431824-43182498.56099.05
5412932-41293294.24894.70
6433560-43356098.95799.45
30min1429239-42923997.97097.671.6198.6098.311.61
2425038-42503897.01197.65
3431659-43165998.52399.15
4432616-43261698.74199.39
5415423-41542394.81795.42
6433671-43367198.98299.64
45min1436133-43613399.54498.371.90100.3499.171.90
2436057-43605799.526100.33
3423861-42386196.74397.54
4438528-438528100.090100.91
5417989-41798995.40396.17
6433331-43333198.90499.73
60min1427573-42757397.59097.241.1598.5598.201.16
2423598-42359896.68397.65
3423820-42382096.73397.69
4430864-43086498.34199.32
5418749-41874995.57696.50
6431518-43151898.49099.48
极限1426674-42667497.38597.041.0198.5198.171.02
2421911-42191196.29897.43
3423580-42358096.67997.79
4429460-42946098.02199.17
5419342-41934295.71196.79
6430062-43006298.15899.31
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