枸橼酸西地那非片项目信息
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250
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%
117.369554659559029560219559719560379558790.03
217.319531169530789530970.01
单位质量响应值RSD%判断
55062.1555060.490.01数据可信
供试品溶液-50224001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%
5min1644061-64406159.22859.985.3759.2359.985.37
2639739-63973958.83158.83
3716000-71600065.84465.84
4660724-66072460.76060.76
5611675-61167556.25056.25
6641417-64141758.98558.98
10min1666301-66630161.27360.543.5061.3760.643.50
2678003-67800362.34962.45
3683008-68300862.81062.92
4642093-64209359.04759.15
5622004-62200457.20057.29
6658448-65844860.55160.65
15min1682068-68206862.72361.193.2662.9261.393.27
2680983-68098362.62362.83
3672373-67237361.83262.05
4671159-67115961.72061.92
5623695-62369557.35557.54
6662202-66220260.89661.10
20min1673887-67388761.97161.122.6362.2861.432.63
2668658-66865861.49061.80
3671768-67176861.77662.09
4661768-66176860.85661.16
5631411-63141158.06558.35
6680564-68056462.58562.89
30min1647830-64783059.57559.403.8459.9859.803.82
2664249-66424961.08561.49
3662463-66246360.92061.34
4637411-63741158.61759.02
5600298-60029855.20455.59
6663109-66310960.98061.38
45min1637501-63750158.62558.212.4959.1358.712.50
2643995-64399559.22259.73
3640475-64047558.89859.42
4624544-62454457.43357.93
5604941-60494155.63156.10
6646509-64650959.45359.96
极限1531191-53119148.84953.244.6049.4553.844.56
2591136-59113654.36154.97
3600179-60017955.19355.81
4579594-57959453.30053.90
5568734-56873452.30152.87
6602508-60250855.40756.01
枸橼酸西地那非片项目信息
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250
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%
117.369531479521549521739528449524579525550.05
217.319530799518629524700.10
单位质量响应值RSD%判断
54870.6855024.260.20数据可信
供试品溶液-50224002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%
5min1591244-59124454.48457.232.7354.4857.232.74
2614230-61423056.60256.60
3633070-63307058.33858.34
4638915-63891558.87758.88
5622064-62206457.32457.32
6626857-62685757.76657.77
10min1594610-59461054.79457.785.1754.8857.885.16
2662481-66248161.04861.14
3588751-58875154.25454.35
4649254-64925459.82959.93
5654593-65459360.32160.42
6612381-61238156.43256.53
15min1671308-67130861.86258.458.3362.0458.648.29
2568602-56860252.39752.59
3647145-64714559.63559.82
4568716-56871652.40852.61
5690252-69025263.60763.80
6659782-65978260.80060.99
20min1616590-61659056.81957.832.4857.1058.122.46
2641060-64106059.07459.36
3610184-61018456.22956.52
4649189-64918959.82360.11
5616815-61681556.84057.14
6631486-63148658.19258.48
30min1659553-65955360.77957.543.2561.1657.923.22
2605258-60525855.77556.16
3624004-62400457.50357.88
4633839-63383958.40958.79
5616225-61622556.78657.18
6607284-60728455.96256.35
45min1630128-63012858.06757.111.7158.5557.591.70
2619362-61936257.07557.55
3603804-60380455.64156.12
4617288-61728856.88457.37
5632752-63275258.30958.80
6615102-61510256.68257.16
极限1596832-59683254.99952.942.0455.5853.512.02
2576016-57601653.08153.65
3568014-56801452.34352.91
4571288-57128852.64553.22
5570589-57058952.58053.17
6563878-56387851.96252.54
枸橼酸西地那非片项目信息
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250
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%
117.369526419542759527509527089529029530550.08
217.319557829555139556480.02
单位质量响应值RSD%判断
54899.4855207.860.40数据可信
供试品溶液-50224003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%
5min1635317-63531758.43356.354.5058.4356.354.50
2625952-62595257.57157.57
3631587-63158758.09058.09
4618203-61820356.85956.86
5603781-60378155.53255.53
6561337-56133751.62851.63
10min1676291-67629162.20158.485.7762.3058.585.77
2664777-66477761.14261.24
3650104-65010459.79359.89
4639805-63980558.84558.94
5602413-60241355.40655.50
6581890-58189053.51953.60
15min1585021-58502153.80757.088.0054.0157.277.97
2688299-68829963.30663.50
3639782-63978258.84359.04
4545925-54592550.21150.40
5643167-64316759.15559.34
6621498-62149857.16257.34
20min1566340-56634052.08858.226.9952.3858.516.96
2691757-69175763.62463.93
3627329-62732957.69857.99
4669132-66913261.54361.82
5633610-63361058.27658.56
6609923-60992356.09756.37
30min1648393-64839359.63558.397.3960.0158.777.36
2683793-68379362.89163.30
3606727-60672755.80356.19
4670143-67014361.63662.01
5644465-64446559.27459.65
6555578-55557851.09951.46
45min1606713-60671355.80256.278.1756.2856.758.14
2658435-65843560.55961.07
3605144-60514455.65756.14
4653903-65390360.14260.62
5626084-62608457.58358.06
6520861-52086147.90648.35
极限1593257-59325754.56453.185.0655.1353.755.05
2609215-60921556.03256.65
3573590-57359052.75553.33
4603970-60397055.54956.13
5552422-55242250.80851.38
6536628-53662849.35649.88
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