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500
标示量(mg)20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%
5min1341888-34188882.71192.656.1582.7192.656.15
2394458-39445895.42995.43
3377812-37781291.40291.40
4376439-37643991.07091.07
5399891-39989196.74496.74
6407372-40737298.55498.55
10min1406491-40649198.34199.711.1298.4899.861.13
2417751-417751101.065101.22
3408482-40848298.82298.97
4411060-41106099.44699.60
5417392-417392100.978101.14
6411778-41177899.62099.78
15min1412118-41211899.702100.110.64100.00100.430.65
2417296-417296100.955101.28
3410490-41049099.30899.63
4413797-413797100.108100.43
5416530-416530100.769101.10
6412557-41255799.808100.14
20min1412037-41203799.682100.030.64100.15100.510.64
2417349-417349100.967101.46
3410609-41060999.33799.82
4413744-413744100.095100.58
5415622-415622100.550101.05
6411377-41137799.523100.02
30min1410713-41071399.362100.842.58100.00101.502.56
2415898-415898100.616101.28
3410488-41048899.30899.96
4438227-438227106.018106.67
5414687-414687100.323100.99
6410978-41097899.426100.09
45min1410703-41070399.36099.710.56100.16100.540.57
2414898-414898100.374101.21
3409450-40945099.05699.87
4413050-41305099.927100.76
5414508-414508100.280101.11
6410338-41033899.271100.10
60min1408736-40873698.88499.410.5299.85100.400.52
2412577-41257799.813100.81
3408737-40873798.88499.86
4412157-41215799.711100.71
5413518-413518100.041101.04
6409657-40965799.106100.10
极限1409083-40908398.96899.290.57100.10100.440.58
2413727-413727100.091101.26
3407615-40761598.61299.76
4410846-41084699.394100.55
5412398-41239899.770100.94
6408806-40880698.901100.06
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500
标示量(mg)20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%
5min1785901-78590194.75794.045.8994.7694.045.89
2816058-81605898.39398.39
3698854-69885484.26284.26
4823420-82342099.28199.28
5796771-79677196.06896.07
6758799-75879991.48991.49
10min1833579-833579100.506100.421.06100.66100.581.07
2832708-832708100.401100.56
3818306-81830698.66498.80
4845661-845661101.963102.13
5835327-835327100.717100.88
6831624-831624100.270100.42
15min1833037-833037100.440100.920.60100.77101.240.60
2831355-831355100.238100.57
3840660-840660101.360101.66
4844573-844573101.831102.17
5834779-834779100.650100.98
6837713-837713101.004101.32
20min1831668-831668100.275100.910.67100.77101.410.67
2830980-830980100.192100.69
3843240-843240101.671102.14
4843761-843761101.733102.24
5834489-834489100.616101.11
6837669-837669100.999101.49
30min1830414-830414100.124100.770.72100.78101.430.71
2828948-82894899.947100.61
3843082-843082101.652102.29
4841686-841686101.483102.16
5832876-832876100.421101.08
6837863-837863101.022101.68
45min1829205-82920599.978100.580.69100.81101.410.69
2827680-82768099.795100.63
3841109-841109101.414102.23
4840882-840882101.386102.23
5831948-831948100.309101.14
6834340-834340100.598101.42
60min1827218-82721899.739100.370.64100.73101.360.63
2826237-82623799.621100.62
3838919-838919101.150102.13
4837654-837654100.997102.01
5830702-830702100.159101.16
6833768-833768100.529101.52
极限1825531-82553199.535100.130.69100.70101.290.68
2823240-82324099.259100.42
3837118-837118100.932102.08
4836602-836602100.870102.05
5828838-82883899.934101.10
6831478-831478100.252101.41
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500
标示量(mg)20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%
5min1333811-33381180.70079.395.4980.7079.395.49
2341065-34106582.45482.45
3317536-31753676.76576.77
4346179-34617983.69083.69
5334339-33433980.82880.83
6297371-29737171.89071.89
10min1396508-39650895.85797.483.7595.9997.613.75
2410662-41066299.27999.42
3405226-40522697.96598.09
4417974-417974101.047101.19
5412651-41265199.76099.89
6376240-37624090.95791.08
15min1418620-418620101.203101.282.06101.50101.582.07
2425207-425207102.795103.10
3424982-424982102.741103.03
4417650-417650100.968101.28
5424474-424474102.618102.92
6402714-40271497.35897.63
20min1412145-41214599.637101.291.84100.10101.761.84
2425173-425173102.787103.26
3426091-426091103.009103.47
4416956-416956100.801101.28
5425352-425352102.830103.30
6408266-40826698.70099.13
30min1411412-41141299.460101.121.85100.09101.761.85
2424879-424879102.716103.36
3426135-426135103.020103.65
4415248-415248100.388101.03
5423958-423958102.493103.14
6408131-40813198.66799.27
45min1410475-41047599.234100.941.78100.03101.741.78
2423502-423502102.383103.20
3424765-424765102.688103.49
4415307-415307100.402101.21
5423550-423550102.395103.21
6407712-40771298.56699.33
60min1409915-40991599.098101.012.10100.06101.982.10
2423607-423607102.408103.40
3424114-424114102.531103.51
4414404-414404100.184101.16
5428286-428286103.540104.52
6406591-40659198.29599.22
极限1409080-40908098.897100.721.50100.02101.861.50
2422025-422025102.026103.18
3422595-422595102.164103.31
4412864-41286499.811100.96
5422020-422020102.025103.18
6411276-41127699.427100.52
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500
标示量(mg)20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%
5min1567115-56711568.22177.199.8368.2277.199.83
2642312-64231277.26777.27
3726440-72644087.38787.39
4572517-57251768.87168.87
5652854-65285478.53578.53
6688626-68862682.83882.84
10min1758109-75810991.19796.333.5491.3196.463.55
2815078-81507898.05098.18
3835781-835781100.540100.69
4776474-77647493.40693.52
5807344-80734497.11997.25
6811949-81194997.67397.81
15min1814970-81497098.037100.421.5898.30100.711.59
2841126-841126101.183101.48
3835655-835655100.525100.84
4827234-82723499.51299.78
5835496-835496100.506100.80
6854034-854034102.736103.04
20min1831369-831369100.009100.941.02100.44101.401.03
2839770-839770101.020101.48
3834400-834400100.374100.85
4832440-832440100.138100.57
5842886-842886101.395101.86
6853939-853939102.724103.20
30min1837893-837893100.794100.760.55101.39101.390.55
2837270-837270100.719101.35
3832901-832901100.194100.84
4832356-832356100.128100.73
5842146-842146101.306101.94
6843269-843269101.441102.08
45min1838349-838349100.849100.690.46101.61101.490.47
2835275-835275100.479101.28
3836177-836177100.588101.40
4830937-83093799.957100.73
5839980-839980101.045101.84
6841624-841624101.243102.06
60min1835620-835620100.521100.410.53101.45101.380.53
2833261-833261100.237101.20
3829602-82960299.797100.78
4830837-83083799.945100.88
5838224-838224100.834101.80
6840888-840888101.154102.14
极限1834960-834960100.441100.330.98101.54101.460.97
2831621-831621100.040101.17
3826157-82615799.382100.53
4826493-82649399.423100.53
5837175-837175100.708101.84
6847958-847958102.005103.15
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