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125
标示量(mg)100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%
117.579528459539679539009527179532019533260.07
217.529548149549619548880.02
单位质量响应值RSD%判断
54258.7454502.740.32数据可信
加速6月-供试品溶液-2024051911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%
5min1363718-36371833.86631.7511.5833.8731.7611.58
2301305-30130528.05528.06
3312096-31209629.06029.06
4307745-30774528.65528.65
5398107-39810737.06837.07
6363219-36321933.82033.82
10min1365991-36599134.07832.788.3534.1332.838.35
2332267-33226730.93830.98
3330769-33076930.79830.85
4319813-31981329.77829.83
5397295-39729536.99337.05
6365894-36589434.06934.13
15min1364074-36407433.90032.768.2934.0132.878.28
2332201-33220130.93231.03
3332057-33205730.91831.02
4319924-31992429.78929.89
5398012-39801237.06037.18
6364812-36481233.96834.08
20min1362677-36267733.76932.638.2033.9432.808.20
2331091-33109130.82830.98
3330968-33096830.81730.97
4318534-31853429.65929.81
5395278-39527836.80536.99
6364161-36416133.90834.08
30min1359129-35912933.43932.378.0233.6732.588.03
2328615-32861530.59830.80
3329037-32903730.63730.84
4316481-31648129.46829.66
5391057-39105736.41236.66
6361290-36129033.64033.87
45min1354963-35496333.05132.047.8133.3332.317.82
2325920-32592030.34730.60
3325904-32590430.34530.60
4313986-31398629.23629.48
5385742-38574235.91736.22
6357879-35787933.32333.61
极限1343507-34350731.98531.187.1732.3231.507.19
2317650-31765029.57729.88
3320198-32019829.81430.12
4308009-30800928.67928.97
5372520-37252034.68635.05
6347331-34733132.34132.68
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125
标示量(mg)100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%
117.579535179544779551939550139536739543750.08
217.529540159540869540500.01
单位质量响应值RSD%判断
54318.4454454.910.18数据可信
加速6月-供试品溶液-2024052011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%
5min1328352-32835230.57032.1811.2730.5732.1811.27
2309259-30925928.79228.79
3348525-34852532.44832.45
4313729-31372929.20929.21
5414353-41435338.57738.58
6359971-35997133.51433.51
10min1345148-34514832.13432.919.6632.1832.979.67
2314116-31411629.24529.29
3349838-34983832.57032.62
4332083-33208330.91730.97
5413122-41312238.46238.53
6366926-36692634.16134.22
15min1343895-34389532.01732.759.4032.1232.869.41
2312835-31283529.12529.22
3348585-34858532.45432.56
4330868-33086830.80430.90
5408683-40868338.04938.18
6365574-36557434.03534.15
20min1341532-34153231.79732.529.1531.9532.689.16
2311528-31152829.00429.15
3346640-34664032.27332.44
4329042-32904230.63430.79
5404252-40425237.63637.83
6362773-36277333.77533.94
30min1338988-33898831.56032.188.7931.7732.408.80
2308797-30879728.74928.94
3344166-34416632.04232.26
4325537-32553730.30830.51
5396638-39663836.92837.18
6359995-35999533.51633.74
45min1336914-33691431.36731.888.6631.6332.158.67
2305768-30576828.46728.71
3340627-34062731.71331.98
4322823-32282330.05530.31
5391736-39173636.47136.79
6356568-35656833.19733.48
极限1327977-32797730.53531.038.1530.8531.358.17
2300260-30026027.95528.24
3330826-33082630.80031.12
4315538-31553829.37729.68
5378947-37894735.28035.66
6345959-34595932.20932.55
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125
标示量(mg)100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%
117.579532719528999536689524109527949530080.06
217.529531059528909529980.02
单位质量响应值RSD%判断
54240.6454394.860.21数据可信
加速6月-供试品溶液-2024052111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%
5min1344833-34483332.14531.519.4532.1531.519.44
2304781-30478128.41228.41
3306013-30601328.52628.53
4326661-32666130.45130.45
5386344-38634436.01536.01
6359327-35932733.49633.50
10min1364522-36452233.98134.073.3234.0334.123.33
2355452-35545233.13533.18
3354756-35475633.07033.12
4364623-36462333.99034.04
5388179-38817936.18636.25
6365332-36533234.05634.11
15min1363786-36378633.91233.943.3834.0234.053.39
2355612-35561233.15033.25
3350816-35081632.70332.81
4364682-36468233.99534.10
5386560-38656036.03536.16
6363275-36327533.86433.98
20min1361028-36102833.65533.843.1633.8234.013.17
2354455-35445533.04233.20
3352000-35200032.81332.97
4363401-36340133.87634.04
5384373-38437335.83136.01
6363066-36306633.84534.01
30min1358596-35859633.42833.603.3833.6533.823.39
2351359-35135932.75332.97
3348502-34850232.48732.70
4360802-36080233.63433.85
5383033-38303335.70635.95
6360385-36038533.59533.82
45min1356639-35663933.24633.323.3733.5233.593.37
2347871-34787132.42832.70
3345125-34512532.17232.44
4357044-35704433.28333.56
5379253-37925335.35435.65
6358432-35843233.41333.69
极限1345551-34555132.21232.223.2032.5532.563.22
2337259-33725931.43931.76
3333390-33339031.07831.40
4345423-34542332.20032.53
5365337-36533734.05734.42
6347052-34705232.35232.69
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