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%
111.803734713733493730663734473729393732540.07
211.793744373724483734420.38
单位质量响应值RSD%判断
31631.6931674.470.10数据可信
长期12月-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%
5min1398140-39814094.93994.124.1194.9494.124.11
2362971-36297186.55386.55
3394722-39472294.12494.12
4401092-40109295.64395.64
5403273-40327396.16396.16
6407988-40798897.28897.29
10min1424271-424271101.17198.862.51101.3399.012.51
2394515-39451594.07594.22
3413645-41364598.63798.79
4417924-41792499.65799.82
5419016-41901699.917100.08
6418019-41801999.68099.84
15min1429483-429483102.41399.502.15102.7499.822.15
2402048-40204895.87196.17
3414694-41469498.88799.21
4420032-420032100.160100.49
5419530-419530100.040100.37
6417686-41768699.60099.93
20min1432804-432804103.20599.922.06103.70100.412.06
2406047-40604796.82597.29
3416986-41698699.43399.92
4420907-420907100.368100.86
5420175-420175100.194100.69
6417372-41737299.525100.02
30min1437142-437142104.240100.252.19104.91100.912.19
2409523-40952397.65498.28
3416663-41666399.356100.01
4421331-421331100.470101.13
5420328-420328100.230100.89
6417568-41756899.572100.23
45min1440083-440083104.941100.552.25105.78101.372.25
2412566-41256698.37999.16
3418211-41821199.726100.54
4420018-420018100.156100.98
5421010-421010100.393101.22
6418100-41810099.699100.53
60min1440586-440586105.061100.472.32106.08101.462.31
2414005-41400598.72399.67
3416851-41685199.401100.38
4420214-420214100.203101.20
5420292-420292100.222101.22
6416052-41605299.211100.20
极限1441782-441782105.346100.292.54106.54101.452.53
2413430-41343098.58599.70
3414054-41405498.73499.88
4419674-419674100.074101.24
5418450-41845099.783100.94
6416082-41608299.218100.38
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%
111.803739753734683743693745613747423742230.14
211.793752133749573750850.05
单位质量响应值RSD%判断
31713.8131813.830.23数据可信
长期12月-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%
5min1399201-39920194.86190.426.6894.8690.426.68
2404866-40486696.20796.21
3386600-38660091.86691.87
4350686-35068683.33283.33
5395084-39508493.88293.88
6346698-34669882.38582.38
10min1412606-41260698.04695.692.9298.2095.842.92
2416468-41646898.96499.12
3402661-40266195.68395.84
4385690-38569091.65091.79
5405954-40595496.46596.62
6392683-39268393.31293.45
15min1416200-41620098.90097.022.0499.2297.332.05
2417779-41777999.27599.60
3407005-40700596.71597.03
4398783-39878394.76195.05
5411247-41124797.72398.04
6398735-39873594.75095.04
20min1414588-41458898.51797.891.3499.0098.361.35
2421075-421075100.059100.55
3409679-40967997.35197.82
4407992-40799296.95097.40
5412723-41272398.07498.55
6405652-40565296.39496.84
30min1414942-41494298.60198.760.5899.2599.400.58
2419989-41998999.801100.46
3412939-41293998.12598.76
4416110-41611098.87999.49
5414573-41457398.51499.16
6415199-41519998.66299.27
45min1417201-41720199.13899.270.7599.95100.070.74
2420118-42011899.831100.66
3413647-41364798.29499.09
4421547-421547100.171100.95
5414790-41479098.56599.37
6419342-41934299.647100.42
60min1415577-41557798.75298.920.7999.7399.880.78
2420015-42001599.807100.80
3412806-41280698.09499.06
4419156-41915699.603100.55
5412278-41227897.96898.94
6417789-41778999.278100.22
极限1412817-41281798.09698.620.8699.2499.760.84
2417160-41716099.128100.28
3409676-40967697.35098.48
4418165-41816599.367100.48
5413746-41374698.31799.45
6418675-41867599.488100.60
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%
111.803752543753523753513748063739253749380.17
211.793752933749653751290.07
单位质量响应值RSD%判断
31774.4131817.560.10数据可信
长期12月-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%
5min1385717-38571791.56494.132.2891.5694.132.28
2410710-41071097.49797.50
3396568-39656894.14094.14
4394796-39479693.71993.72
5402114-40211495.45695.46
6389186-38918692.38792.39
10min1412991-41299198.03898.221.6598.1998.381.65
2419020-41902099.46999.63
3411085-41108597.58697.74
4413567-41356798.17598.33
5422881-422881100.386100.55
6403066-40306695.68295.84
15min1417243-41724399.04898.621.5699.3698.941.56
2415754-41575498.69499.02
3412219-41221997.85598.17
4415450-41545098.62298.94
5425887-425887101.100101.43
6406131-40613196.41096.72
20min1420914-42091499.91998.461.83100.4098.951.83
2418235-41823599.28399.78
3409519-40951997.21497.70
4413669-41366998.19998.68
5423219-423219100.466100.96
6403095-40309595.68996.16
30min1421099-42109999.96398.741.71100.6199.391.71
2418245-41824599.28599.94
3411698-41169897.73198.38
4417306-41730699.06399.71
5423425-423425100.515101.18
6403975-40397595.89896.53
45min1426710-426710101.29598.792.09102.1199.602.08
2417473-41747399.10299.93
3409560-40956097.22498.03
4414267-41426798.34199.15
5424704-424704100.819101.65
6404168-40416895.94496.74
60min1426826-426826101.32298.682.32102.3199.662.31
2416453-41645398.86099.85
3409708-40970897.25998.23
4415813-41581398.70899.68
5424552-424552100.783101.78
6400743-40074395.13196.08
极限1426444-426444101.23298.252.31102.3899.392.30
2415377-41537798.60599.76
3408531-40853196.97998.11
4411592-41159297.70698.85
5421629-421629100.089101.25
6399684-39968494.87995.99
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%
111.803753993753933774903773743777553766820.32
211.793751093755813753450.09
单位质量响应值RSD%判断
31922.2031835.880.20数据可信
长期12月-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%
5min1405180-40518095.93492.973.5795.9392.973.56
2411278-41127897.37797.38
3376052-37605289.03789.04
4394625-39462593.43493.43
5378986-37898689.73289.73
6389943-38994392.32692.33
10min1413538-41353897.91297.881.9498.0798.041.95
2423603-423603100.295100.46
3404308-40430895.72795.88
4417099-41709998.75698.91
5403592-40359295.55895.71
6418391-41839199.06199.22
15min1412431-41243197.65098.261.8497.9798.581.84
2422797-422797100.105100.43
3407555-40755596.49696.80
4416439-41643998.59998.92
5406368-40636896.21596.52
6424537-424537100.517100.84
20min1413777-41377797.96998.701.6098.4599.181.61
2421352-42135299.763100.26
3408383-40838396.69297.16
4420820-42082099.637100.12
5411353-41135397.39597.86
6425487-425487100.742101.23
30min1412488-41248897.66498.551.6498.3199.201.64
2420334-42033499.521100.18
3406691-40669196.29196.92
4418583-41858399.10799.76
5413293-41329397.85498.49
6426026-426026100.869101.52
45min1411008-41100897.31398.751.5698.1399.561.56
2420199-42019999.490100.32
3407642-40764296.51697.31
4418856-41885699.17299.99
5419579-41957999.343100.14
6425177-425177100.668101.49
60min1409170-40917096.87898.781.5997.8599.751.59
2417274-41727498.79799.79
3409678-40967896.99897.95
4420190-42019099.487100.47
5420933-42093399.663100.62
6425899-425899100.839101.83
极限1411223-41122397.36498.581.6998.5099.721.68
2415158-41515898.29699.45
3406088-40608896.14897.26
4420190-42019099.487100.63
5419797-41979799.394100.52
6425640-425640100.778101.94
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%
111.803753043754133723923727473727033737120.41
211.793751923751743751830.01
单位质量响应值RSD%判断
31670.5131822.140.34数据可信
中间条件12月-供试品溶液-2024072621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%
5min1360136-36013685.62589.253.8885.6389.253.87
2384543-38454391.42891.43
3397354-39735494.47494.47
4380652-38065290.50390.50
5366174-36617487.06187.06
6363380-36338086.39786.40
10min1382363-38236390.91094.583.7691.0594.733.76
2399198-39919894.91395.07
3421490-421490100.213100.37
4405177-40517796.33496.49
5396838-39683894.35294.50
6381693-38169390.75190.89
15min1389942-38994292.71296.083.3793.0196.383.37
2402819-40281995.77496.08
3424541-424541100.938101.26
4414492-41449298.54998.86
5402605-40260595.72396.03
6390135-39013592.75893.05
20min1394808-39480893.86996.733.0294.3297.203.03
2403642-40364295.96996.44
3424928-424928101.030101.52
4417562-41756299.27999.75
5405826-40582696.48996.95
6394325-39432593.75494.20
30min1401212-40121295.39297.492.8796.0098.122.88
2402199-40219995.62696.26
3427916-427916101.741102.40
4421339-421339100.177100.82
5407339-40733996.84897.47
6400131-40013195.13495.74
45min1404604-40460496.19897.582.4396.9698.382.43
2403723-40372395.98996.78
3425836-425836101.246102.08
4420184-42018499.902100.71
5405559-40555996.42597.21
6402690-40269095.74396.51
60min1406115-40611596.55797.922.6097.4898.872.60
2405951-40595196.51897.47
3427108-427108101.548102.55
4423819-423819100.767101.74
5405403-40540396.38897.33
6402671-40267195.73896.66
极限1408133-40813397.03797.222.9898.1298.342.97
2403061-40306195.83196.94
3424351-424351100.893102.06
4421667-421667100.255101.40
5403975-40397596.04897.15
6392247-39224793.26094.34
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