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%
117.062342952342192344742342862343302343210.05
216.982331752333742332740.07
单位质量响应值RSD%判断
13735.1113738.160.02数据可信
供试品溶液-2024051611批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271490-271490100.074100.471.29100.07100.471.29
2277299-277299102.215102.22
3269176-26917699.22199.22
4273083-273083100.661100.66
5275765-275765101.650101.65
6268578-26857899.00199.00
10min1277463-277463102.276102.011.29102.44102.181.29
2278133-278133102.523102.69
3275488-275488101.548101.71
4275274-275274101.469101.64
5282361-282361104.081104.25
6271698-271698100.151100.32
15min1277009-277009102.108101.661.03102.45102.001.03
2276633-276633101.970102.31
3275436-275436101.528101.86
4274927-274927101.341101.68
5279685-279685103.095103.44
6271124-27112499.939100.27
20min1276112-276112101.778101.351.14102.29101.861.15
2276364-276364101.871102.38
3275776-275776101.654102.16
4272280-272280100.365100.87
5278926-278926102.815103.33
6270244-27024499.615100.11
30min1275778-275778101.655101.101.01102.33101.781.00
2274551-274551101.202101.88
3273305-273305100.743101.42
4273806-273806100.928101.60
5278224-278224102.556103.24
6269971-26997199.514100.18
45min1275984-275984101.730100.841.11102.58101.691.11
2274838-274838101.308102.16
3270423-27042399.681100.52
4273277-273277100.733101.57
5277203-277203102.180103.04
6269725-26972599.423100.25
极限1274778-274778101.286101.112.61102.30102.122.59
2274146-274146101.053102.07
3286181-286181105.489106.50
4265691-26569197.93698.95
5276589-276589101.953102.98
6268444-26844498.95199.95
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%
117.062334572332372329922327782327792330490.13
216.982332232331942332080.01
单位质量响应值RSD%判断
13660.5513734.280.39数据可信
供试品溶液-2024051611批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273568-273568101.129101.732.22101.13101.732.22
2275378-275378101.798101.80
3275334-275334101.782101.78
4270756-270756100.090100.09
5286607-286607105.949105.95
6269501-26950199.62699.63
10min1274515-274515101.479102.062.26101.65102.232.26
2277572-277572102.610102.78
3273871-273871101.241101.41
4272793-272793100.843101.01
5287771-287771106.380106.56
6270041-27004199.82699.99
15min1274630-274630101.522102.562.39101.86102.902.38
2277520-277520102.590102.93
3283241-283241104.705105.04
4272379-272379100.690101.02
5287064-287064106.118106.47
6269792-26979299.734100.07
20min1274035-274035101.302101.712.27101.81102.222.27
2276964-276964102.385102.90
3272611-272611100.776101.29
4271671-271671100.428100.93
5286627-286627105.957106.49
6268854-26885499.38799.89
30min1273296-273296101.029101.432.24101.70102.102.24
2276208-276208102.105102.79
3272282-272282100.654101.33
4270411-27041199.962100.63
5285667-285667105.602106.31
6268370-26837099.20899.87
45min1273294-273294101.028101.332.27101.87102.182.27
2275702-275702101.918102.77
3271350-271350100.309101.16
4269947-26994799.791100.63
5285731-285731105.626106.51
6268619-26861999.300100.13
极限1273281-273281101.023101.112.28102.04102.122.28
2274836-274836101.598102.62
3271194-271194100.252101.27
4269861-26986199.759100.76
5284916-284916105.324106.38
6266963-26696398.68899.68
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%
117.062330062331222327562330292335102330850.12
216.982329822330282330050.02
单位质量响应值RSD%判断
13662.6613722.320.31数据可信
供试品溶液-2024051612批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1278471-278471102.979100.742.62102.98100.742.62
2273661-273661101.200101.20
3263788-26378897.54997.55
4273853-273853101.271101.27
5264088-26408897.66097.66
6280711-280711103.807103.81
10min1280894-280894103.875102.052.27104.05102.222.27
2276388-276388102.208102.38
3266241-26624198.45698.62
4275870-275870102.017102.19
5272387-272387100.729100.89
6283910-283910104.990105.16
15min1280705-280705103.805101.602.65104.15101.932.65
2275842-275842102.006102.35
3265992-26599298.36498.69
4275837-275837102.005102.34
5266367-26636798.50398.83
6283643-283643104.891105.24
20min1280148-280148103.599102.313.76104.12102.823.76
2278388-278388102.948103.46
3258320-25832095.52796.02
4287692-287692106.389106.90
5271994-271994100.583101.08
6283437-283437104.815105.34
30min1279821-279821103.478101.122.65104.17101.802.65
2274237-274237101.413102.09
3264950-26495097.97998.63
4274654-274654101.567102.25
5264956-26495697.98198.64
6282087-282087104.316105.01
45min1278414-278414102.958100.822.61103.82101.672.61
2273950-273950101.307102.16
3263890-26389097.58798.40
4274339-274339101.451102.31
5264320-26432097.74698.57
6280936-280936103.890104.76
极限1277996-277996102.803100.832.82103.84101.852.82
2273969-273969101.314102.33
3263300-26330097.36898.34
4274208-274208101.402102.43
5263970-26397097.61698.60
6282578-282578104.497105.54
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%
117.062333192334872334052335532335232334570.05
216.982338382337182337780.04
单位质量响应值RSD%判断
13684.4713767.840.43数据可信
供试品溶液-2024051613批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1275372-275372101.58399.562.11101.5899.562.11
2276805-276805102.112102.11
3269031-26903199.24499.24
4264425-26442597.54597.55
5271032-27103299.98299.98
6262732-26273296.92096.92
10min1285129-285129105.183100.882.92105.35101.052.92
2280501-280501103.475103.65
3273047-273047100.726100.89
4270785-27078599.891100.05
5264422-26442297.54497.71
6266961-26696198.48198.64
15min1279815-279815103.222101.062.25103.57101.402.25
2279621-279621103.151103.49
3272495-272495100.522100.86
4270738-27073899.874100.20
5263936-26393697.36597.69
6277144-277144102.237102.56
20min1279701-279701103.180100.352.45103.70100.852.45
2279364-279364103.056103.57
3272577-272577100.552101.05
4270730-27073099.871100.37
5263372-26337297.15797.65
6266375-26637598.26498.76
30min1279195-279195102.994100.292.40103.68100.962.40
2279390-279390103.066103.75
3272216-272216100.419101.09
4270203-27020399.676100.34
5263235-26323597.10697.76
6266927-26692798.46899.13
45min1279143-279143102.974100.582.61103.83101.412.60
2279108-279108102.961103.82
3271350-271350100.100100.94
4277510-277510102.372103.20
5262711-26271196.91397.73
6266026-26602698.13698.96
极限1278212-278212102.63199.742.51103.66100.752.50
2278530-278530102.748103.78
3270936-27093699.947100.95
4266424-26642498.28299.28
5262245-26224596.74197.72
6265987-26598798.12199.11
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%
117.062340642342742337782343142339532340770.10
216.982336022335322335670.03
单位质量响应值RSD%判断
13720.8113755.420.18数据可信
供试品溶液-2024051612批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1274769-274769101.27299.951.17101.2799.941.17
2268753-26875399.05599.05
3267843-26784398.71998.72
4272890-272890100.579100.58
5268501-26850198.96298.96
6274289-274289101.095101.09
10min1277754-277754102.372100.941.09102.54101.101.09
2271562-271562100.090100.25
3269950-26995099.49699.66
4275123-275123101.402101.57
5272674-272674100.500100.66
6276134-276134101.775101.94
15min1277955-277955102.446100.551.68102.79100.881.68
2267270-26727098.50898.84
3267382-26738298.54998.88
4275329-275329101.478101.81
5272603-272603100.474100.81
6276275-276275101.827102.17
20min1277090-277090102.127100.801.69102.64101.311.69
2268000-26800098.77799.27
3269080-26908099.17599.67
4279172-279172102.895103.40
5271512-271512100.071100.57
6276155-276155101.783102.29
30min1276961-276961102.080101.241.88102.76101.911.87
2266767-26676798.32398.98
3282160-282160103.996104.66
4274641-274641101.225101.90
5271977-271977100.243100.91
6275633-275633101.590102.27
45min1276024-276024101.734100.761.14102.58101.601.13
2275369-275369101.493102.32
3268105-26810598.81699.65
4274197-274197101.061101.91
5271191-27119199.953100.79
6275365-275365101.492102.34
极限1276205-276205101.801100.182.44102.82101.192.41
2265821-26582197.97498.97
3267653-26765398.64999.65
4265310-26531097.78698.80
5281731-281731103.838104.84
6274136-274136101.039102.05
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%
117.062337892335702335152336352334092335840.07
216.982337782336412337100.05
单位质量响应值RSD%判断
13691.9113763.840.38数据可信
供试品溶液-2024051613批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1276584-276584102.01799.301.71102.0299.301.71
2268544-26854499.05299.05
3262592-26259296.85696.86
4270243-27024399.67999.68
5267103-26710398.52098.52
6270165-27016599.65099.65
10min1281125-281125103.692100.651.97103.86100.811.98
2272826-272826100.631100.80
3264994-26499497.74297.90
4273343-273343100.822100.99
5269836-26983699.52899.69
6275071-275071101.459101.63
15min1285001-285001105.122100.932.48105.46101.262.48
2273138-273138100.746101.08
3264853-26485397.69098.01
4273377-273377100.834101.17
5269525-26952599.41499.74
6275963-275963101.788102.12
20min1280481-280481103.455100.192.07103.97100.692.06
2268924-26892499.19299.69
3264349-26434997.50597.99
4272734-272734100.597101.10
5268727-26872799.11999.62
6274516-274516101.255101.76
30min1279694-279694103.164100.722.12103.85101.382.12
2277013-277013102.176102.84
3264268-26426897.47598.12
4274043-274043101.080101.75
5268078-26807898.88099.54
6275223-275223101.515102.19
45min1279389-279389103.052100.612.26103.91101.442.26
2278185-278185102.608103.44
3263524-26352497.20098.01
4273277-273277100.798101.64
5267588-26758898.69999.52
6274572-274572101.275102.12
极限1279267-279267103.007100.962.82104.04101.962.81
2276429-276429101.960102.97
3262255-26225596.73297.71
4282558-282558104.221105.23
5266841-26684198.42499.41
6274944-274944101.412102.42
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