枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.174864054860924860584861854862194861920.03
214.214874454881264877860.10
单位质量响应值RSD%判断
34311.3634326.950.04数据可信
供试品溶液-2024041221批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1175100-17510032.29340.2112.5132.2940.2112.51
2226054-22605441.69041.69
3247671-24767145.67745.68
4242676-24267644.75644.76
5216607-21660739.94839.95
6200128-20012836.90936.91
5min1280867-28086751.79957.035.8951.8057.035.89
2329059-32905960.68760.69
3312625-31262557.65657.66
4314102-31410257.92857.93
5323851-32385159.72659.73
6294727-29472754.35554.36
10min1306848-30684856.59158.113.3556.5958.113.35
2326435-32643560.20360.20
3323126-32312659.59359.59
4312886-31288657.70457.70
5321816-32181659.35159.35
6299496-29949655.23555.23
15min1299709-29970955.27458.102.9755.2758.102.97
2318249-31824958.69358.69
3313466-31346657.81157.81
4312776-31277657.68457.68
5317760-31776058.60358.60
6328274-32827460.54260.54
20min1309933-30993357.16056.771.0057.1656.771.00
2306363-30636356.50156.50
3306750-30675056.57356.57
4304015-30401556.06856.07
5307058-30705856.62956.63
6312775-31277557.68457.68
30min1301137-30113755.53755.187.5255.5455.187.51
2311678-31167857.48157.48
3303679-30367956.00656.01
4319395-31939558.90558.90
5303971-30397156.06056.06
6255429-25542947.10847.11
45min1299463-29946355.22955.341.8155.2355.331.80
2305883-30588356.41356.41
3295191-29519154.44154.44
4302464-30246455.78255.78
5304860-30486056.22456.22
6292371-29237153.92153.92
极限1286215-28621552.78553.622.6652.7953.622.66
2299428-29942855.22255.22
3289104-28910453.31853.32
4282745-28274552.14552.15
5301184-30118455.54655.55
6285656-28565652.68252.68
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.174936464864284856954861674853694874610.72
214.214864044865894864960.03
单位质量响应值RSD%判断
34400.9234236.170.34数据可信
供试品溶液-2024041221批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1201707-20170737.20141.8213.7137.2041.8213.71
2190877-19087735.20335.20
3217949-21794940.19640.20
4275610-27561050.83150.83
5247985-24798545.73645.74
6226478-22647841.76941.77
5min1313077-31307757.74155.054.6657.7455.054.66
2286575-28657552.85352.85
3307627-30762756.73656.74
4309398-30939857.06257.06
5278541-27854151.37151.37
6295676-29567654.53154.53
10min1279668-27966851.57952.806.8551.5852.796.85
2287977-28797753.11253.11
3312549-31254957.64357.64
4305292-30529256.30556.30
5264782-26478248.83448.83
6267335-26733549.30549.30
15min1306358-30635856.50254.345.7556.5054.345.75
2287893-28789353.09653.10
3313238-31323857.77057.77
4306466-30646656.52156.52
5285345-28534552.62652.63
6268615-26861549.54149.54
20min1306365-30636556.50353.843.4456.5053.843.44
2282229-28222952.05152.05
3292853-29285354.01154.01
4297113-29711354.79654.80
5293989-29398954.22054.22
6278928-27892851.44351.44
30min1301217-30121755.55355.595.4955.5555.595.49
2301498-30149855.60555.61
3304365-30436556.13456.13
4307778-30777856.76356.76
5271581-27158150.08850.09
6322067-32206759.39959.40
45min1285446-28544652.64553.903.6652.6453.903.67
2310464-31046457.25957.26
3286015-28601552.75052.75
4297967-29796754.95454.95
5281188-28118851.85951.86
6292459-29245953.93853.94
极限1287216-28721652.97152.996.6952.9753.006.68
2271248-27124850.02650.03
3283361-28336152.26052.26
4296506-29650654.68554.68
5266199-26619949.09549.10
6319535-31953558.93258.93
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