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%
112.113947243952933949553950673944063948890.09
212.053953803950713952260.06
单位质量响应值RSD%判断
32608.5132798.840.42数据可信
供试品溶液-6021201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%
5min1405365-40536593.55894.441.5793.5694.441.57
2402329-40232992.85792.86
3404115-40411593.26993.27
4410836-41083694.82194.82
5413509-41350995.43795.44
6419032-41903296.71296.71
10min1412450-41245095.19396.221.4595.3596.371.45
2409990-40999094.62594.78
3416785-41678596.19496.35
4414805-41480595.73795.89
5426652-42665298.47198.63
6420598-42059897.07497.23
15min1412873-41287395.29196.020.7195.6196.340.71
2412709-41270995.25395.57
3418229-41822996.52796.84
4414878-41487895.75396.07
5417846-41784696.43896.76
6419628-41962896.85097.17
20min1412337-41233795.16795.710.8795.6496.190.87
2409197-40919794.44294.91
3416267-41626796.07496.55
4414021-41402195.55696.03
5417557-41755796.37296.86
6418785-41878596.65597.14
30min1423583-42358397.76395.931.3098.3996.571.29
2407511-40751194.05394.68
3416153-41615396.04896.68
4412555-41255595.21795.85
5416317-41631796.08696.73
6417807-41780796.42997.07
45min1410735-41073594.79795.911.8295.5996.711.81
2407251-40725193.99394.78
3429040-42904099.02299.82
4412933-41293395.30596.10
5415874-41587495.98396.79
6417629-41762996.38897.19
60min1410765-41076594.80495.641.8095.7696.601.79
2406071-40607193.72194.66
3415337-41533795.85996.82
4411362-41136294.94295.90
5414898-41489895.75896.72
6427900-42790098.75999.73
极限1409627-40962794.54195.291.3495.6596.401.34
2405502-40550293.58994.69
3421725-42172597.33498.46
4411174-41117494.89996.01
5414078-41407895.56996.69
6415077-41507795.79996.93
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%
112.113942723941723939823939733937873940370.05
212.053851173875813863490.46
单位质量响应值RSD%判断
32538.1532062.161.05数据可信
供试品溶液-6021201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%
5min1408048-40804895.35894.583.2895.3694.583.28
2411386-41138696.13896.14
3416414-41641497.31397.31
4394138-39413892.10792.11
5415065-41506596.99897.00
6383152-38315289.54089.54
10min1425026-42502699.32697.132.1699.4897.292.16
2417258-41725897.51097.67
3422618-42261898.76398.93
4404741-40474194.58594.74
5419698-41969898.08098.24
6404456-40445694.51994.67
15min1425335-42533599.39897.211.8499.7297.531.84
2416715-41671597.38397.71
3421285-42128598.45198.78
4406261-40626194.94095.25
5418847-41884797.88298.21
6407448-40744895.21895.52
20min1425431-42543199.42097.572.3599.9198.052.34
2415727-41572797.15297.64
3420510-42051098.27098.76
4405636-40563694.79495.26
5430248-430248100.546101.03
6407516-40751695.23495.70
30min1425765-42576599.49897.081.77100.1597.721.77
2415459-41545997.09097.74
3419749-41974998.09298.75
4405962-40596294.87095.50
5417243-41724397.50798.16
6408275-40827595.41196.04
45min1424770-42477099.26697.212.50100.0998.022.49
2414395-41439596.84197.65
3431444-431444100.825101.64
4405823-40582394.83895.62
5414134-41413496.78097.60
6405401-40540194.73995.52
60min1425071-42507199.33695.552.72100.3296.522.71
2413650-41365096.66797.64
3412375-41237596.36997.36
4393581-39358191.97792.92
5408965-40896595.57296.55
6399597-39959793.38394.32
极限1425596-42559699.45996.941.76100.6198.071.77
2413283-41328396.58197.71
3419096-41909697.94099.09
4403546-40354694.30695.40
5413406-41340696.61097.75
6414058-41405896.76297.86
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%
112.113878963880533883023877363923043888580.50
212.053876143862303869220.26
单位质量响应值RSD%判断
32110.4932109.710.01数据可信
供试品溶液-6021301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%
5min1383030-38303090.03693.435.4890.0493.435.48
2367210-36721086.31886.32
3394002-39400292.61592.62
4430203-430203101.125101.13
5409951-40995196.36496.36
6400314-40031494.09994.10
10min1398830-39883093.75097.984.3293.9098.144.32
2390547-39054791.80391.95
3429396-429396100.935101.09
4434791-434791102.203102.37
5427200-427200100.419100.58
6420275-42027598.79198.95
15min1398675-39867593.71498.084.6694.0298.404.66
2394662-39466292.77193.07
3427849-427849100.572100.89
4445561-445561104.735105.07
5426031-426031100.144100.47
6410766-41076696.55696.88
20min1398188-39818893.59997.684.1394.0698.164.14
2394701-39470192.78093.23
3424279-42427999.732100.22
4438035-438035102.966103.48
5427044-427044100.382100.88
6410948-41094896.59997.08
30min1397510-39751093.44097.323.9094.0697.963.90
2394651-39465192.76893.37
3424367-42436799.753100.41
4434459-434459102.125102.81
5424121-42412199.695100.36
6408934-40893496.12596.77
45min1396673-39667393.24397.133.6294.0297.943.62
2396755-39675593.26394.02
3424840-42484099.864100.69
4431279-431279101.378102.23
5422025-42202599.203100.03
6407794-40779495.85796.66
60min1395929-39592993.06897.594.4294.0098.564.42
2395205-39520592.89893.81
3424100-42410099.690100.68
4438012-438012102.961103.98
5430774-430774101.259102.25
6406917-40691795.65196.61
极限1394898-39489892.82696.853.5493.9197.993.55
2395830-39583093.04594.12
3422546-42254699.325100.48
4429548-429548100.971102.17
5420812-42081298.918100.08
6408544-40854496.03497.16
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%
112.113990153956463965553960713955183965610.37
212.053970283964203967240.11
单位质量响应值RSD%判断
32746.5732923.150.39数据可信
供试品溶液-6021301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%
5min1402982-40298292.63693.763.7392.6493.763.73
2385544-38554488.62888.63
3427144-42714498.19098.19
4401765-40176592.35692.36
5406999-40699993.56093.56
6422858-42285897.20597.21
10min1422335-42233597.08597.042.4797.2497.202.47
2409306-40930694.09094.24
3437420-437420100.553100.72
4420458-42045896.65396.81
5413297-41329795.00795.16
6429965-42996598.83999.00
15min1437990-437990100.68497.812.83101.0098.132.82
2411389-41138994.56994.87
3438293-438293100.753101.08
4420200-42020096.59496.91
5413713-41371395.10395.42
6431420-43142099.17399.50
20min1425147-42514797.73197.482.0998.2297.962.10
2411870-41187094.67995.14
3437287-437287100.522101.02
4419183-41918396.36096.84
5420890-42089096.75397.23
6429887-42988798.82199.31
30min1426929-42692998.14197.653.1198.7998.303.11
2412017-41201794.71395.33
3447252-447252102.813103.48
4420257-42025796.60797.24
5412508-41250894.82695.46
6429907-42990798.82699.48
45min1429791-42979198.79997.292.3699.6198.102.36
2411854-41185494.67695.45
3436567-436567100.357101.19
4419886-41988696.52297.32
5412803-41280394.89495.69
6428542-42854298.51299.33
60min1429950-42995098.83597.712.1999.8198.682.19
2417621-41762196.00196.94
3437777-437777100.635101.64
4420383-42038396.63697.59
5413516-41351695.05896.01
6431008-43100899.079100.06
极限1433322-43332299.61197.562.77100.7598.692.76
2412141-41214194.74295.84
3437327-437327100.531101.70
4418979-41897996.31397.43
5411081-41108194.49895.61
6433479-43347999.647100.80
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