枸橼酸西地那非口崩片项目信息
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%
114.164920414925554921974922444919784922030.05
214.074921504923624922560.04
单位质量响应值RSD%判断
34760.1034986.210.46数据可信
供试品溶液-2024041121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%
2min1203731-20373136.97743.3913.5236.9843.3913.51
2253211-25321145.95745.96
3201909-20190936.64636.65
4278758-27875850.59450.59
5230502-23050241.83641.84
6266288-26628848.33148.33
5min1313628-31362856.92358.415.1156.9258.415.11
2332531-33253160.35460.35
3295261-29526153.58953.59
4320115-32011558.10058.10
5342641-34264162.18962.19
6326678-32667859.29159.29
10min1314929-31492957.15956.013.1057.1656.013.10
2305926-30592655.52555.52
3314702-31470257.11857.12
4313700-31370056.93656.94
5312090-31209056.64456.64
6290371-29037152.70252.70
15min1303089-30308955.01054.855.4455.0154.855.44
2326262-32626259.21659.22
3295026-29502653.54653.55
4286950-28695052.08152.08
5316462-31646257.43757.44
6285438-28543851.80651.81
20min1319196-31919657.93356.733.4157.9356.743.41
2312490-31249056.71656.72
3312446-31244656.70856.71
4323648-32364858.74158.74
5315041-31504157.17957.18
6292730-29273053.13053.13
30min1298657-29865754.20653.722.9754.2153.722.98
2300861-30086154.60654.61
3304269-30426955.22455.22
4298681-29868154.21054.21
5294179-29417953.39353.39
6279363-27936350.70450.70
45min1281705-28170551.12954.343.6451.1354.343.63
2310437-31043756.34456.34
3293045-29304553.18753.19
4304521-30452155.27055.27
5308724-30872456.03356.03
6297846-29784654.05854.06
极限1296720-29672053.85452.182.7753.8552.182.77
2297479-29747953.99253.99
3284912-28491251.71151.71
4286533-28653352.00552.01
5280357-28035750.88450.88
6278983-27898350.63550.63
枸橼酸西地那非口崩片项目信息
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%
114.164914304914014919544917524916224916320.05
214.074954764987914971340.48
单位质量响应值RSD%判断
34719.7735332.911.24数据可信
供试品溶液-2024041121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%
2min1216909-21690939.19940.6113.7639.2040.6113.76
2284296-28429651.37751.38
3200089-20008936.15936.16
4220570-22057039.86039.86
5201427-20142736.40136.40
6225003-22500340.66240.66
5min1311777-31177756.34354.884.7856.3454.884.78
2328411-32841159.34959.35
3298199-29819953.88953.89
4293195-29319552.98552.98
5301872-30187254.55354.55
6288506-28850652.13852.14
10min1312715-31271556.51354.8510.5456.5154.8510.53
2352038-35203863.61963.62
3284761-28476151.46151.46
4322356-32235658.25558.25
5286897-28689751.84751.85
6262452-26245247.42947.43
15min1287669-28766951.98655.5810.4951.9955.5810.49
2358345-35834564.75964.76
3267379-26737948.32048.32
4322656-32265658.30958.31
5318048-31804857.47657.48
6291079-29107952.60352.60
20min1301182-30118254.42852.267.5854.4352.277.58
2306208-30620855.33755.34
3268687-26868748.55648.56
4288722-28872252.17752.18
5312748-31274856.51856.52
6257710-25771046.57246.57
30min1279906-27990650.58352.303.0950.5852.303.09
2300305-30030554.27054.27
3289516-28951652.32052.32
4295036-29503653.31853.32
5293959-29395953.12353.12
6277700-27770050.18550.18
45min1290396-29039652.47952.084.0452.4852.084.03
2303486-30348654.84554.84
3292949-29294952.94052.94
4290952-29095252.58052.58
5282655-28265551.08051.08
6268826-26882648.58148.58
极限1289892-28989252.38849.753.5952.3949.753.59
2285467-28546751.58851.59
3269264-26926448.66048.66
4265944-26594448.06048.06
5270919-27091948.95948.96
6270147-27014748.82048.82
枸橼酸西地那非口崩片项目信息
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%
114.164914664911784913954911634915404913480.04
214.074949194967454958320.27
单位质量响应值RSD%判断
34699.7235240.371.10数据可信
供试品溶液-2024041321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%
2min1211863-21186338.34844.1010.4138.3544.1010.41
2233779-23377942.31542.31
3264697-26469747.91147.91
4273740-27374049.54849.55
5220048-22004839.82939.83
6257883-25788346.67846.68
5min1331274-33127459.96258.912.0359.9658.912.03
2333767-33376760.41360.41
3318859-31885957.71557.71
4323708-32370858.59258.59
5317526-31752657.47357.47
6327704-32770459.31659.32
10min1323842-32384258.61759.763.3658.6259.763.36
2335859-33585960.79260.79
3317094-31709457.39557.40
4347360-34736062.87362.87
5322558-32255858.38458.38
6334336-33433660.51660.52
15min1343392-34339262.15556.377.9562.1656.377.96
2319021-31902157.74457.74
3320207-32020757.95957.96
4322526-32252658.37858.38
5278126-27812650.34250.34
6285432-28543251.66451.66
20min1298530-29853054.03556.014.3954.0456.014.40
2325662-32566258.94658.95
3325555-32555558.92758.93
4294158-29415853.24453.24
5302647-30264754.78054.78
6309972-30997256.10656.11
30min1307525-30752555.66355.185.0955.6655.185.08
2299032-29903254.12654.13
3314249-31424956.88056.88
4303071-30307154.85754.86
5325647-32564758.94358.94
6279653-27965350.61850.62
45min1296509-29650953.66953.282.7953.6753.282.79
2296902-29690253.74053.74
3293451-29345153.11653.12
4300483-30048354.38954.39
5300193-30019354.33654.34
6278489-27848950.40850.41
极限1299588-29958854.22751.265.8454.2351.265.85
2294785-29478553.35753.36
3299648-29964854.23754.24
4272940-27294049.40349.40
5264508-26450847.87747.88
6267723-26772348.45948.46
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