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%
112.233840623840573842203841413837543840470.05
212.283840303837163838730.06
单位质量响应值RSD%判断
31402.0431260.020.33数据可信
供试品溶液-BXJVV61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%
5min1341888-34188882.36492.266.1582.3692.266.15
2394458-39445895.02995.03
3377812-37781291.01991.02
4376439-37643990.68890.69
5399891-39989196.33896.34
6407372-40737298.14098.14
10min1406491-40649197.92899.291.1298.0699.441.13
2417751-417751100.640100.80
3408482-40848298.40798.56
4411060-41106099.02899.18
5417392-417392100.554100.71
6411778-41177899.20199.36
15min1412118-41211899.28399.690.6499.58100.010.65
2417296-417296100.531100.86
3410490-41049098.89199.21
4413797-41379799.688100.00
5416530-416530100.346100.67
6412557-41255799.38999.72
20min1412037-41203799.26499.610.6499.73100.090.64
2417349-417349100.543101.04
3410609-41060998.92099.40
4413744-41374499.675100.16
5415622-415622100.127100.62
6411377-41137799.10599.60
30min1410713-41071398.945100.422.5899.58101.072.56
2415898-415898100.194100.86
3410488-41048898.89199.54
4438227-438227105.573106.22
5414687-41468799.902100.56
6410978-41097899.00999.67
45min1410703-41070398.94299.290.5699.74100.110.57
2414898-41489899.953100.78
3409450-40945098.64099.45
4413050-41305099.508100.33
5414508-41450899.859100.69
6410338-41033898.85499.68
60min1408736-40873698.46898.990.5299.4399.970.53
2412577-41257799.394100.39
3408737-40873798.46999.44
4412157-41215799.293100.28
5413518-41351899.620100.62
6409657-40965798.69099.68
极限1409083-40908398.55298.870.5799.68100.020.58
2413727-41372799.671100.83
3407615-40761598.19899.34
4410846-41084698.977100.13
5412398-41239899.351100.51
6408806-40880698.48599.64
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%
112.237698827699327702777697837696907699130.03
212.287710307707897709100.03
单位质量响应值RSD%判断
62952.8262777.690.20数据可信
供试品溶液-BXJX091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%
5min1785901-78590194.35993.655.8994.3693.655.89
2816058-81605897.98097.98
3698854-69885483.90883.91
4823420-82342098.86498.86
5796771-79677195.66495.66
6758799-75879991.10591.11
10min1833579-833579100.084100.001.06100.24100.151.06
2832708-83270899.979100.14
3818306-81830698.25098.39
4845661-845661101.534101.70
5835327-835327100.294100.45
6831624-83162499.849100.00
15min1833037-833037100.019100.500.60100.34100.820.60
2831355-83135599.817100.15
3840660-840660100.934101.24
4844573-844573101.404101.74
5834779-834779100.228100.55
6837713-837713100.580100.90
20min1831668-83166899.854100.490.67100.35100.980.67
2830980-83098099.772100.27
3843240-843240101.244101.72
4843761-843761101.306101.81
5834489-834489100.193100.69
6837669-837669100.575101.06
30min1830414-83041499.704100.350.72100.36101.010.71
2828948-82894899.528100.19
3843082-843082101.225101.87
4841686-841686101.057101.73
5832876-83287699.999100.66
6837863-837863100.598101.25
45min1829205-82920599.559100.160.69100.38100.980.69
2827680-82768099.376100.20
3841109-841109100.988101.80
4840882-840882100.961101.80
5831948-83194899.888100.72
6834340-834340100.175101.00
60min1827218-82721899.32099.940.64100.31100.940.63
2826237-82623799.202100.20
3838919-838919100.725101.70
4837654-837654100.573101.58
5830702-83070299.738100.73
6833768-833768100.106101.09
极限1825531-82553199.11799.710.69100.27100.870.68
2823240-82324098.842100.00
3837118-837118100.509101.65
4836602-836602100.447101.62
5828838-82883899.515100.67
6831478-83147899.832100.99
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%
112.233843163841123843583841003840823841940.04
212.283845023840423842720.09
单位质量响应值RSD%判断
31414.0631292.510.28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%
5min1333811-33381180.36179.055.4980.3679.065.49
2341065-34106582.10782.11
3317536-31753676.44376.44
4346179-34617983.33983.34
5334339-33433980.48880.49
6297371-29737171.58971.59
10min1396508-39650895.45597.073.7595.5997.203.75
2410662-41066298.86299.00
3405226-40522697.55397.68
4417974-417974100.622100.76
5412651-41265199.34199.48
6376240-37624090.57590.69
15min1418620-418620100.778100.862.06101.07101.152.07
2425207-425207102.364102.67
3424982-424982102.309102.60
4417650-417650100.544100.85
5424474-424474102.187102.49
6402714-40271496.94997.22
20min1412145-41214599.219100.871.8499.68101.331.84
2425173-425173102.355102.83
3426091-426091102.576103.04
4416956-416956100.377100.85
5425352-425352102.399102.87
6408266-40826698.28598.72
30min1411412-41141299.043100.701.8599.67101.331.85
2424879-424879102.285102.93
3426135-426135102.587103.22
4415248-41524899.966100.61
5423958-423958102.063102.70
6408131-40813198.25398.85
45min1410475-41047598.817100.521.7899.61101.321.79
2423502-423502101.953102.77
3424765-424765102.257103.06
4415307-41530799.980100.79
5423550-423550101.965102.78
6407712-40771298.15298.91
60min1409915-40991598.682100.592.1099.64101.552.10
2423607-423607101.978102.96
3424114-424114102.101103.07
4414404-41440499.763100.74
5428286-428286103.105104.09
6406591-40659197.88298.81
极限1409080-40908098.481100.301.5099.60101.441.50
2422025-422025101.598102.75
3422595-422595101.735102.88
4412864-41286499.392100.53
5422020-422020101.596102.75
6411276-41127699.010100.10
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%
112.237718787718477717787715017718657717740.03
212.287726157725687725920.01
单位质量响应值RSD%判断
63104.9962914.660.22数据可信
供试品溶液-2024073021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%
5min1567115-56711567.93576.869.8367.9376.869.83
2642312-64231276.94276.94
3726440-72644087.02087.02
4572517-57251768.58268.58
5652854-65285478.20578.21
6688626-68862682.49082.49
10min1758109-75810990.81495.933.5490.9396.063.55
2815078-81507897.63897.77
3835781-835781100.118100.26
4776474-77647493.01493.13
5807344-80734496.71196.84
6811949-81194997.26397.40
15min1814970-81497097.62599.991.5897.89100.281.59
2841126-841126100.758101.05
3835655-835655100.103100.41
4827234-82723499.09499.36
5835496-835496100.084100.38
6854034-854034102.304102.60
20min1831369-83136999.589100.521.02100.02100.971.02
2839770-839770100.596101.05
3834400-83440099.953100.43
4832440-83244099.718100.15
5842886-842886100.969101.43
6853939-853939102.293102.76
30min1837893-837893100.371100.340.55100.96100.960.55
2837270-837270100.296100.92
3832901-83290199.773100.42
4832356-83235699.708100.31
5842146-842146100.880101.51
6843269-843269101.015101.66
45min1838349-838349100.426100.270.46101.19101.060.47
2835275-835275100.057100.85
3836177-836177100.165100.98
4830937-83093799.538100.30
5839980-839980100.621101.42
6841624-841624100.818101.63
60min1835620-835620100.09999.990.53101.03100.950.52
2833261-83326199.816100.78
3829602-82960299.378100.36
4830837-83083799.526100.46
5838224-838224100.411101.37
6840888-840888100.730101.71
极限1834960-834960100.02099.910.98101.11101.030.97
2831621-83162199.620100.75
3826157-82615798.965100.11
4826493-82649399.005100.10
5837175-837175100.285101.41
6847958-847958101.577102.72
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