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%
117.63 4862464862304862654860824861424861930.02
217.614877894869724873800.12
单位质量响应值RSD%判断
27577.6027676.320.26数据可信
供试品溶液-24004002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%
5min1331377-33137760.73561.073.7060.7361.073.70
2334268-33426861.26561.26
3329100-32910060.31860.32
4349519-34951964.06064.06
5341655-34165562.61962.62
6313216-31321657.40657.41
10min1328439-32843960.19661.411.6060.3061.521.60
2338928-33892862.11962.22
3342082-34208262.69762.80
4336541-33654161.68161.79
5329316-32931660.35760.46
6335135-33513561.42461.52
15min1331950-33195060.84061.282.3761.0461.482.37
2337728-33772861.89962.10
3331490-33149060.75660.96
4348748-34874863.91964.13
5327173-32717359.96460.17
6328984-32898460.29660.49
20min1311703-31170357.12959.285.7657.4359.595.73
2342305-34230562.73863.05
3345031-34503163.23763.54
4332011-33201160.85161.17
5305460-30546055.98556.29
6304122-30412255.74056.04
30min1329549-32954960.40058.263.3660.8058.663.34
2329720-32972060.43160.84
3318927-31892758.45358.86
4313641-31364157.48457.90
5313452-31345257.45057.85
6301963-30196355.34455.74
45min1294959-29495954.06055.213.3854.5655.713.35
2315882-31588257.89558.41
3292350-29235053.58254.09
4306423-30642356.16156.67
5290386-29038653.22253.72
6307435-30743556.34756.83
极限1280228-28022851.36050.783.0051.9551.382.99
2288152-28815252.81353.42
3275157-27515750.43151.03
4280468-28046851.40452.01
5275256-27525650.44951.03
6263149-26314948.23048.81
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%
117.63 4862664863064857794879844858644864400.19
217.614853804858394856100.07
单位质量响应值RSD%判断
27591.6127575.810.05数据可信
供试品溶液-24004002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%
5min1488831-48883189.73390.121.5889.7390.121.58
2494612-49461290.79490.79
3500077-50007791.79891.80
4479037-47903787.93587.94
5486318-48631889.27289.27
6496732-49673291.18491.18
10min1504465-50446592.60393.711.1392.7593.861.13
2512714-51271494.11794.27
3517832-51783295.05795.21
4504854-50485492.67592.82
5507305-50730593.12593.27
6515707-51570794.66794.82
15min1510198-51019893.65694.790.9493.9695.100.94
2517573-51757395.00995.32
3521988-52198895.82096.13
4511502-51150293.89594.20
5515948-51594894.71195.02
6520945-52094595.62895.94
20min1514520-51452094.44995.030.8194.9195.500.81
2517952-51795295.07995.55
3523220-52322096.04696.52
4512973-51297394.16594.62
5515493-51549394.62895.09
6522093-52209395.83996.31
30min1515329-51532994.59794.940.7795.2195.560.77
2518278-51827895.13995.76
3520620-52062095.56996.20
4512078-51207894.00194.62
5514294-51429494.40795.03
6522476-52247695.90996.54
45min1513247-51324794.21594.760.8994.9995.550.89
2516502-51650294.81395.60
3522016-52201695.82596.62
4511136-51113693.82894.60
5513103-51310394.18994.97
6521370-52137095.70696.50
极限1511967-51196793.98094.600.8494.9195.540.84
2516401-51640194.79495.74
3520232-52023295.49796.45
4509798-50979893.58294.51
5513496-51349694.26195.19
6520064-52006495.46796.41
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%
117.63 4848604851604851464850964849404850400.03
217.614859304859504859400.01
单位质量响应值RSD%判断
27512.2027594.550.22数据可信
供试品溶液-24004002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%
5min1501778-50177892.21292.510.6992.2192.500.69
2501995-50199592.25192.25
3502461-50246192.33792.34
4504118-50411892.64292.64
5509900-50990093.70493.70
6500048-50004891.89491.89
10min1522814-52281496.07796.550.5696.2396.700.57
2525885-52588596.64296.80
3523866-52386696.27196.42
4525382-52538296.54996.70
5530879-53087997.55997.72
6523436-52343696.19296.34
15min1528509-52850997.12497.170.6897.4497.480.68
2531143-53114397.60897.92
3526138-52613896.68897.00
4528016-52801697.03397.35
5534292-53429298.18798.51
6524327-52432796.35596.67
20min1531864-53186497.74097.680.6298.2298.160.62
2532865-53286597.92498.40
3528341-52834197.09397.57
4529798-52979897.36197.84
5537186-53718698.71899.20
6529123-52912397.23797.71
30min1530843-53084397.55397.740.6698.1998.380.66
2532003-53200397.76698.41
3527708-52770896.97797.61
4533693-53369398.07798.72
5537501-53750198.77699.42
6529297-52929797.26997.90
45min1532545-53254597.86697.440.6898.6798.240.68
2531607-53160797.69398.50
3526449-52644996.74597.54
4526521-52652196.75997.56
5535416-53541698.39399.20
6528880-52888097.19297.99
极限1527569-52756996.95197.140.5997.9298.100.59
2530006-53000697.39998.37
3525217-52521796.51997.48
4526131-52613196.68797.65
5533834-53383498.10299.08
6528723-52872397.16398.12
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