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1000
标示量(mg)5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%
111.973844543851023851703851423853483850430.09
211.993857723858673858200.02
单位质量响应值RSD%判断
32167.3432178.480.03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%
5min1208069-20806998.04095.005.4698.0495.005.46
2206462-20646297.28297.28
3200543-20054394.49394.49
4181061-18106185.31485.31
5212337-212337100.051100.05
6201298-20129894.84994.85
10min1213034-213034100.37998.143.89100.5498.303.90
2211138-21113899.48699.65
3206559-20655997.32897.49
4192957-19295790.91991.06
5215755-215755101.661101.83
6210219-21021999.05399.21
15min1213408-213408100.55598.572.84100.8998.892.84
2210754-21075499.30599.63
3207234-20723497.64697.97
4198335-19833593.45393.75
5214805-214805101.213101.55
6210616-21061699.24099.56
20min1213342-213342100.52498.422.59101.0298.902.60
2210261-21026199.07299.57
3206685-20668597.38797.87
4199248-19924893.88394.33
5213921-213921100.797101.30
6209800-20980098.85599.34
30min1212428-212428100.09398.402.21100.7699.052.22
2209537-20953798.73199.39
3206081-20608197.10397.75
4201163-20116394.78695.39
5213797-213797100.738101.41
6210029-21002998.96399.62
45min1211759-21175999.77898.262.09100.6199.082.10
2209072-20907298.51299.34
3205421-20542196.79297.60
4201863-20186395.11595.88
5213957-213957100.814101.65
6209182-20918298.56499.38
60min1211340-21134099.58198.122.02100.5899.102.02
2209167-20916798.55799.54
3204568-20456896.39097.36
4202015-20201595.18796.11
5213130-213130100.424101.43
6209245-20924598.59499.58
极限1215010-215010101.31098.502.14102.4799.642.14
2208533-20853398.25899.41
3207422-20742297.73598.86
4202088-20208895.22196.30
5212535-212535100.144101.32
6208698-20869898.33699.48
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1000
标示量(mg)5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%
111.973851983851353849723854793847323851030.08
211.993858623859973859300.03
单位质量响应值RSD%判断
32172.3532187.660.04数据可信
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%
5min1201834-20183495.08197.103.5795.0897.103.57
2207899-20789997.93897.94
3201181-20118194.77394.77
4210301-21030199.06999.07
5197757-19775793.16093.16
6217815-217815102.609102.61
10min1206988-20698897.50998.772.2697.6798.932.26
2213368-213368100.514100.68
3205881-20588196.98797.15
4211261-21126199.52299.69
5204188-20418896.19096.34
6216269-216269101.881102.05
15min1208373-20837398.16198.812.8898.4899.132.88
2211829-21182999.789100.12
3206677-20667797.36297.68
4208293-20829398.12398.45
5202776-20277695.52495.84
6220519-220519103.883104.22
20min1207948-20794897.96197.851.6498.4598.351.64
2209769-20976998.81999.32
3207044-20704497.53598.02
4207165-20716597.59298.09
5202089-20208995.20195.68
6212284-212284100.004100.52
30min1208731-20873198.33098.482.3798.9899.142.36
2209491-20949198.68899.35
3215388-215388101.466102.11
4205126-20512696.63297.29
5202180-20218095.24495.88
6213379-213379100.519101.20
45min1208196-20819698.07897.291.3298.8998.111.33
2208615-20861598.27599.10
3206192-20619297.13497.95
4204977-20497796.56197.38
5202000-20200095.15995.95
6209129-20912998.51799.37
60min1207585-20758597.79096.731.3898.7797.711.38
2207374-20737497.69198.68
3205113-20511396.62597.60
4203728-20372895.97396.95
5200589-20058994.49495.45
6207646-20764697.81998.83
极限1207201-20720197.60996.601.5098.7597.741.50
2207235-20723597.62598.78
3204481-20448196.32897.46
4202385-20238595.34096.48
5200671-20067194.53395.64
6208350-20835098.15099.33
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1000
标示量(mg)5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%
111.973861613858313859653861783857413859750.06
211.993862923859953861440.06
单位质量响应值RSD%判断
32245.2032205.500.09数据可信
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%
5min1204948-20494896.41296.752.4196.4196.752.41
2204774-20477496.33096.33
3211200-21120099.35399.35
4211205-21120599.35599.36
5203713-20371395.83195.83
6198207-19820793.24193.24
10min1211216-21121699.36099.522.1099.5299.682.10
2207744-20774497.72797.89
3216316-216316101.760101.93
4217053-217053102.106102.27
5210859-21085999.19299.35
6206087-20608796.94897.10
15min1211561-21156199.52399.501.9799.8599.831.97
2207905-20790597.80398.13
3216461-216461101.828102.16
4216442-216442101.819102.15
5209914-20991498.74899.07
6206805-20680597.28597.60
20min1211534-21153499.51099.272.07100.0099.762.07
2206823-20682397.29497.78
3215694-215694101.467101.97
4216227-216227101.718102.22
5210023-21002398.79999.29
6205799-20579996.81297.29
30min1211317-21131799.40899.012.08100.0799.672.08
2206480-20648097.13397.78
3215539-215539101.394102.07
4215126-215126101.200101.87
5209399-20939998.50699.16
6204953-20495396.41497.05
45min1210865-21086599.19598.832.16100.0299.652.16
2206153-20615396.97997.79
3215181-215181101.226102.07
4215388-215388101.323102.17
5208190-20819097.93798.76
6204712-20471296.30197.10
60min1210212-21021298.88898.502.0199.8899.492.01
2206100-20610096.95497.93
3213748-213748100.552101.56
4214530-214530100.919101.93
5207752-20775297.73198.71
6204020-20402095.97596.94
极限1209253-20925398.43798.172.1599.5999.322.15
2204371-20437196.14097.27
3213771-213771100.562101.74
4213762-213762100.558101.74
5207487-20748797.60698.75
6203417-20341795.69296.81
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