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500
标示量(mg)25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%
117.272400172398922400782399682398772399660.04
217.232401752400102400920.05
单位质量响应值RSD%判断
13894.9613934.530.21数据可信
供试品溶液-2024051611批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1266986-26698697.15498.591.9297.1598.591.92
2274040-27404099.72199.72
3276388-276388100.575100.58
4262772-26277295.62195.62
5274563-27456399.91199.91
6270802-27080298.54398.54
10min1270144-27014498.30399.751.0398.4799.921.03
2275296-275296100.178100.34
3277475-277475100.971101.14
4273241-27324199.43099.59
5276604-276604100.654100.82
6272017-27201798.98599.15
15min1270273-27027398.35099.851.0698.68100.181.06
2275737-275737100.339100.67
3277951-277951101.144101.48
4273509-27350999.52899.85
5276637-276637100.666101.00
6272248-27224899.06999.40
20min1269797-26979798.17799.560.9898.67100.060.98
2274733-27473399.973100.47
3277067-277067100.823101.33
4272656-27265699.21799.71
5275525-275525100.261100.76
6271772-27177298.89699.39
30min1271687-27168798.86599.630.7099.52100.300.70
2274717-27471799.967100.63
3276090-276090100.467101.14
4271885-27188598.93799.59
5275536-275536100.265100.93
6272889-27288999.30299.96
45min1268458-26845897.69099.170.9898.51100.000.98
2273822-27382299.642100.48
3275434-275434100.228101.07
4271464-27146498.78499.60
5274862-274862100.020100.86
6271039-27103998.62999.45
极限1268028-26802897.53399.051.3298.51100.041.32
2273522-27352299.533100.53
3277346-277346100.924101.93
4270685-27068598.50099.49
5274570-27457099.914100.92
6268961-26896197.87398.86
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500
标示量(mg)25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%
117.272397082397532396292399072399232397840.06
217.232386972387852387410.03
单位质量响应值RSD%判断
13884.4213856.120.15数据可信
供试品溶液-2024051611批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1267096-26709697.50698.321.6397.5198.321.63
2271218-27121899.01199.01
3268839-26883998.14298.14
4276450-276450100.921100.92
5269125-26912598.24698.25
6263306-26330696.12296.12
10min1270279-27027998.66899.081.1698.8399.241.16
2272551-27255199.49799.66
3269844-26984498.50998.67
4277266-277266101.218101.39
5269899-26989998.52998.69
6268654-26865498.07598.23
15min1270014-27001498.57199.241.9698.9099.571.96
2271708-27170899.18999.52
3269236-26923698.28798.61
4282469-282469103.118103.45
5269203-26920398.27598.60
6268442-26844297.99798.32
20min1269150-26915098.25698.921.2898.7599.411.29
2275271-275271100.490100.99
3268864-26886498.15198.64
4275546-275546100.590101.10
5268848-26884898.14598.64
6268071-26807197.86298.35
30min1269130-26913098.24898.541.1298.9099.201.13
2270840-27084098.87399.54
3268611-26861198.05998.71
4275599-275599100.610101.29
5268035-26803597.84998.50
6267345-26734597.59798.25
45min1267978-26797897.82898.241.1998.6599.061.19
2270139-27013998.61799.45
3267890-26789097.79698.61
4275040-275040100.406101.25
5267411-26741197.62198.44
6266174-26617497.16997.98
极限1267334-26733497.59398.411.2398.5799.401.23
2269714-26971498.46199.45
3267221-26722197.55198.53
4274119-274119100.070101.08
5272975-27297599.652100.63
6266097-26609797.14198.12
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500
标示量(mg)25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%
117.272401242401622404482402192400162401940.07
217.232402462404492403480.06
单位质量响应值RSD%判断
13908.1613949.390.21数据可信
供试品溶液-2024051613批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1270706-27070698.40997.971.6198.4197.971.61
2267308-26730897.17397.17
3276611-276611100.555100.56
4265469-26546996.50596.50
5271447-27144798.67898.68
6265447-26544796.49796.50
10min1272261-27226198.97499.001.3699.1499.161.36
2268083-26808397.45597.62
3278753-278753101.334101.50
4269417-26941797.94098.10
5273176-27317699.30799.47
6272254-27225498.97199.13
15min1272274-27227498.97998.561.6899.3198.891.68
2268116-26811697.46797.79
3278867-278867101.375101.71
4267908-26790897.39297.72
5272837-27283799.18399.51
6266702-26670296.95397.28
20min1271378-27137898.65398.401.6299.1598.891.62
2267710-26771097.32097.81
3277955-277955101.044101.55
4267508-26750897.24697.73
5273048-27304899.26099.76
6266493-26649396.87797.36
30min1271206-27120698.59098.231.5699.2598.891.56
2267118-26711897.10497.75
3276962-276962100.683101.36
4267538-26753897.25797.91
5272602-27260299.09899.76
6265852-26585296.64497.29
45min1270794-27079498.44197.991.6599.2698.811.65
2266749-26674996.97097.78
3276649-276649100.569101.41
4266349-26634996.82597.64
5271925-27192598.85299.68
6264829-26482996.27297.08
极限1270066-27006698.17697.771.6099.1698.751.59
2265916-26591696.66797.64
3276001-276001100.334101.34
4266352-26635296.82697.80
5270941-27094198.49499.48
6264409-26440996.12097.09
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