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%
117.182375482373882373152374152372742373880.05
217.062370962371052371000.01
单位质量响应值RSD%判断
13817.6913898.010.41数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1276683-276683101.097101.271.56101.10101.271.56
2275110-275110100.522100.52
3281755-281755102.950102.95
4271034-27103499.03399.03
5275838-275838100.788100.79
6282497-282497103.221103.22
10min1280500-280500102.492102.121.41102.66102.291.41
2276262-276262100.943101.11
3283981-283981103.763103.94
4274126-274126100.163100.33
5278560-278560101.783101.95
6283458-283458103.572103.74
15min1279094-279094101.978101.721.50102.32102.061.50
2274725-274725100.381100.72
3283290-283290103.511103.86
4272952-27295299.734100.07
5277658-277658101.453101.79
6282643-282643103.275103.62
20min1279149-279149101.998101.912.37102.51102.422.36
2275094-275094100.516101.02
3281765-281765102.954103.47
4270400-27040098.80199.30
5277262-277262101.308101.82
6289806-289806105.892106.41
30min1278230-278230101.662101.351.38102.34102.031.38
2273878-273878100.072100.74
3281905-281905103.005103.69
4272373-27237399.522100.18
5276804-276804101.141101.82
6281111-281111102.715103.41
45min1277661-277661101.454102.785.18102.30103.635.15
2271888-27188899.345100.18
3310045-310045113.287114.15
4271118-27111899.06399.89
5275972-275972100.837101.68
6281091-281091102.707103.57
极限1276855-276855101.160100.881.44102.18101.901.44
2273482-27348299.927100.93
3280778-280778102.593103.64
4270291-27029198.76199.76
5275223-275223100.563101.58
6279946-279946102.289103.32
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%
117.182368782371092368062369092370122369430.06
217.062368362368302368330.01
单位质量响应值RSD%判断
13791.7913882.360.47数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1278291-278291101.837101.111.99101.84101.111.99
2274651-274651100.505100.51
3285361-285361104.425104.42
4277737-277737101.635101.63
5270334-27033498.92698.93
6271405-27140599.31799.32
10min1281523-281523103.020101.141.69103.19101.311.69
2276075-276075101.026101.19
3278397-278397101.876102.05
4280605-280605102.684102.85
5270751-27075199.07899.24
6271034-27103499.18299.35
15min1280294-280294102.570100.921.78102.91101.261.78
2275734-275734100.902101.24
3278285-278285101.835102.18
4280586-280586102.677103.02
5269154-26915498.49498.82
6270656-27065699.04399.37
20min1279986-279986102.458100.521.76102.97101.031.76
2274488-274488100.446100.95
3277413-277413101.516102.03
4278402-278402101.878102.39
5268062-26806298.09498.59
6269862-26986298.75399.25
30min1279001-279001102.097100.291.81102.78100.961.81
2274019-274019100.274100.95
3276870-276870101.317102.00
4278318-278318101.847102.53
5267947-26794798.05298.71
6268214-26821498.15098.81
45min1279224-279224102.179100.211.71103.03101.051.70
2273452-273452100.067100.91
3276312-276312101.113101.96
4277379-277379101.504102.35
5268163-26816398.13198.95
6268505-26850598.25699.08
极限1281311-281311102.942100.211.96103.97101.221.96
2273115-27311599.943100.95
3275535-275535100.829101.85
4277381-277381101.504102.52
5267352-26735297.83498.82
6268408-26840898.22199.21
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%
117.182370652370272371062370242366612369770.08
217.062372322370192371260.07
单位质量响应值RSD%判断
13793.7713899.530.55数据可信
供试品溶液-2024051612批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1269892-26989298.69699.920.9398.7099.920.93
2273711-273711100.092100.09
3271794-27179499.39199.39
4276542-276542101.128101.13
5271871-27187199.42099.42
6275639-275639100.797100.80
10min1271948-27194899.448100.630.9399.61100.790.93
2274805-274805100.492100.66
3272888-27288899.79199.96
4278163-278163101.720101.89
5275302-275302100.674100.84
6277933-277933101.636101.80
15min1272221-27222199.548100.590.9399.88100.930.93
2274445-274445100.361100.70
3272802-27280299.760100.09
4278208-278208101.737102.08
5274815-274815100.496100.83
6278008-278008101.664102.00
20min1271396-27139699.246102.094.1499.74102.594.13
2274710-274710100.458100.96
3271849-27184999.41299.91
4278088-278088101.693102.20
5302135-302135110.487110.99
6276863-276863101.245101.75
30min1271292-27129299.208100.200.8799.87100.870.87
2273805-273805100.127100.80
3271591-27159199.31799.98
4277486-277486101.473102.15
5274038-274038100.212100.90
6275743-275743100.836101.51
45min1270793-27079399.025100.280.9599.85101.120.95
2274232-274232100.283101.12
3272018-27201899.473100.30
4277304-277304101.406102.25
5273991-273991100.195101.05
6276945-276945101.275102.12
极限1273908-273908100.164100.311.18101.16101.321.17
2272617-27261799.692100.70
3270517-27051798.92499.92
4279684-279684102.277103.29
5273006-27300699.835100.85
6276181-276181100.996102.01
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%
117.182369012370052370782370432371212370300.04
217.062379782377822378800.06
单位质量响应值RSD%判断
13796.8613943.730.75数据可信
供试品溶液-2024051612批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271133-27113398.98299.591.0798.9899.581.07
2273245-27324599.75399.75
3273000-27300099.66499.66
4275281-275281100.496100.50
5268042-26804297.85497.85
6276026-276026100.768100.77
10min1273921-273921100.000100.231.10100.16100.401.10
2274765-274765100.308100.47
3275776-275776100.677100.84
4275642-275642100.628100.80
5269118-26911898.24698.41
6278114-278114101.531101.70
15min1273587-27358799.878100.301.00100.21100.641.00
2275520-275520100.584100.92
3275358-275358100.524100.86
4275823-275823100.694101.03
5270030-27003098.57998.91
6278175-278175101.553101.89
20min1272572-27257299.507101.283.26100.01101.783.24
2274427-274427100.185100.69
3275860-275860100.708101.21
4295041-295041107.710108.21
5269531-26953198.39798.89
6277160-277160101.182101.69
30min1271711-27171199.19399.941.0299.86100.611.01
2273796-27379699.954100.62
3275554-275554100.596101.27
4275422-275422100.548101.23
5269375-26937598.34099.00
6276736-276736101.028101.70
45min1272044-27204499.31599.871.12100.14100.701.12
2273231-27323199.748100.58
3274370-274370100.164101.00
4275456-275456100.560101.41
5268703-26870398.09598.91
6277614-277614101.348102.19
极限1273746-27374699.93699.851.03100.93100.861.03
2272698-27269899.553100.55
3275205-275205100.469101.47
4275705-275705100.651101.67
5268299-26829997.94798.93
6275489-275489100.572101.58
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%
117.182375752377232376802375492378052376660.05
217.062379262377772378520.05
单位质量响应值RSD%判断
13833.8813942.090.56数据可信
供试品溶液-2024051613批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263796-26379696.18099.261.6296.1899.261.62
2272890-27289099.49599.50
3273623-27362399.76399.76
4272606-27260699.39299.39
5276817-276817100.927100.93
6273728-27372899.80199.80
10min1267183-26718397.415100.261.5897.57100.431.58
2275708-275708100.523100.69
3275705-275705100.522100.69
4274924-274924100.237100.40
5280516-280516102.276102.44
6275935-275935100.605100.77
15min1266895-26689597.310100.161.5397.63100.491.53
2275261-275261100.360100.69
3274896-274896100.227100.56
4274808-274808100.195100.53
5279121-279121101.767102.11
6277284-277284101.097101.43
20min1267610-26761097.570100.051.3398.06100.551.33
2275375-275375100.401100.90
3274413-274413100.051100.55
4274851-274851100.210100.71
5278611-278611101.581102.09
6275572-275572100.473100.98
30min1267894-26789497.67499.871.2698.32100.541.26
2273129-27312999.582100.25
3274401-274401100.046100.71
4274725-274725100.164100.83
5278445-278445101.521102.20
6274940-274940100.243100.91
45min1268214-26821497.79099.951.2998.60100.781.29
2272544-27254499.369100.20
3277908-277908101.325102.16
4273530-27353099.729100.56
5276964-276964100.981101.83
6275626-275626100.493101.33
极限1274372-274372100.036100.100.70101.01101.100.70
2273462-27346299.704100.70
3272566-27256699.377100.38
4273313-27331399.650100.65
5277610-277610101.216102.23
6276038-276038100.643101.65
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%
117.182369872371182372312369722375452371710.10
217.062375762375792375780.01
单位质量响应值RSD%判断
13805.0613926.030.62数据可信
供试品溶液-2024051613批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1277018-277018101.164100.741.71101.16100.741.71
2280698-280698102.508102.51
3280500-280500102.436102.44
4270981-27098198.96098.96
5276395-276395100.937100.94
6269503-26950398.42098.42
10min1271879-27187999.287101.011.5299.46101.181.53
2280966-280966102.606102.78
3281841-281841102.925103.10
4274045-274045100.078100.24
5277674-277674101.404101.57
6273173-27317399.76099.92
15min1273573-27357399.906102.743.95100.24103.083.94
2281056-281056102.639102.98
3282660-282660103.225103.57
4275159-275159100.485100.82
5302500-302500110.470110.81
6273097-27309799.732100.06
20min1271959-27195999.317101.312.2199.82101.822.20
2280571-280571102.462102.97
3288170-288170105.237105.75
4274626-274626100.291100.79
5276669-276669101.037101.56
6272571-27257199.540100.04
30min1272000-27200099.332100.701.50100.00101.381.50
2281804-281804102.912103.60
3279439-279439102.048102.74
4272171-27217199.394100.06
5276062-276062100.815101.50
6272997-27299799.696100.36
45min1271464-27146499.136100.661.5499.97101.501.54
2280790-280790102.542103.40
3280622-280622102.480103.34
4272613-27261399.556100.39
5276095-276095100.827101.68
6272203-27220399.406100.23
极限1272302-27230299.442100.261.55100.44101.281.55
2280532-280532102.447103.47
3277912-277912101.491102.52
4272026-27202699.341100.34
5275489-275489100.606101.63
6269067-26906798.26199.25
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