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625
标示量(mg)20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%
117.331879131879061871861879341885511878980.26
217.481878031878081878060.01
单位质量响应值RSD%判断
10842.3510744.050.65数据可信
供试品溶液-B514807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%
5min1106756-10675650.08446.195.5050.0846.195.50
2101297-10129747.52347.52
391214-9121442.79242.79
494499-9449944.33444.33
599228-9922846.55246.55
697769-9776945.86845.87
10min1116309-11630954.56649.355.8054.6549.435.79
2100203-10020347.01047.09
399861-9986146.84946.92
4103981-10398148.78248.86
5103508-10350848.56048.64
6107293-10729350.33650.41
15min1110023-11002351.61751.471.7751.7951.631.76
2107363-10736350.36950.53
3108109-10810950.71950.87
4111082-11108252.11352.27
5109119-10911951.19351.35
6112586-11258652.81952.98
20min1122290-12229057.37254.113.5957.6354.363.59
2112374-11237452.72052.96
3111263-11126352.19852.43
4114845-11484553.87954.12
5113259-11325953.13553.38
6118005-11800555.36155.61
30min1120637-12063756.59656.781.6056.9557.121.60
2119770-11977056.18956.52
3118372-11837255.53455.85
4122663-12266357.54757.88
5121050-12105056.79057.12
6123708-12370858.03758.38
45min1135541-13554163.58860.832.8764.0461.262.87
2126784-12678459.48059.90
3124852-12485258.57458.99
4130288-13028861.12461.55
5129287-12928760.65461.08
6131166-13116661.53661.97
极限1147137-14713769.02869.082.4069.5869.612.39
2144786-14478667.92568.45
3143358-14335867.25667.77
4152531-15253171.55972.09
5145351-14535168.19168.72
6150317-15031770.52071.06
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625
标示量(mg)20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%
117.331881521882101879351879301877831880020.10
217.481878751879731879240.04
单位质量响应值RSD%判断
10848.3610750.800.64数据可信
供试品溶液-B514807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%
5min195929-9592944.97844.874.0644.9844.884.07
297489-9748945.70945.71
393113-9311343.65843.66
494800-9480044.44944.45
590824-9082442.58442.58
6102100-10210047.87147.87
10min1104542-10454249.01649.193.5549.0949.273.56
2106747-10674750.05050.13
3102629-10262948.11948.19
4103747-10374748.64448.72
5100570-10057047.15447.22
6111271-11127152.17152.25
15min1110898-11089851.99652.132.8852.1552.282.87
2113284-11328453.11553.27
3109918-10991851.53751.69
4109541-10954151.36051.52
5107151-10715150.24050.39
6116274-11627454.51754.68
20min1116681-11668154.70855.743.4754.9555.983.47
2122922-12292257.63457.88
3120796-12079656.63756.88
4119694-11969456.12156.36
5111635-11163552.34252.58
6121530-12153056.98157.24
30min1122098-12209857.24857.912.5657.5858.252.56
2126902-12690259.50059.84
3123871-12387158.07958.41
4121640-12164057.03357.37
5119252-11925255.91356.23
6127330-12733059.70160.05
45min1129877-12987760.89561.752.5961.3262.182.59
2134377-13437763.00563.45
3135645-13564563.59964.03
4128724-12872460.35460.78
5127519-12751959.78960.20
6134045-13404562.84963.30
极限1152365-15236571.43970.142.1671.9770.672.16
2151804-15180471.17671.72
3148933-14893369.83070.37
4147810-14781069.30369.83
5144273-14427367.64568.16
6152325-15232571.42071.98
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