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%
117.454812894814644816534815534814794814880.03
217.594818104825384821740.11
单位质量响应值RSD%判断
27592.4427411.820.47数据可信
供试品溶液-2024041511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%
5min1365422-36542267.27967.901.9467.2867.901.94
2374067-37406768.87168.87
3365874-36587467.36267.36
4364986-36498667.19967.20
5361713-36171366.59666.60
6380770-38077070.10570.10
10min1363878-36387866.99568.531.9467.1168.641.94
2375070-37507069.05569.17
3370435-37043568.20268.31
4368879-36887967.91668.03
5369905-36990568.10568.22
6384973-38497370.87971.00
15min1363107-36310766.85368.532.0167.0868.762.01
2374547-37454768.95969.19
3368888-36888867.91768.14
4367112-36711267.59067.82
5375480-37548069.13169.36
6384126-38412670.72370.96
20min1361182-36118266.49968.121.9066.8368.461.90
2373600-37360068.78569.13
3369495-36949568.02968.37
4366801-36680167.53367.87
5367160-36716067.59967.94
6381716-38171670.27970.63
30min1360211-36021166.32067.721.8866.7768.181.88
2369266-36926667.98768.45
3368019-36801967.75768.21
4365618-36561867.31567.77
5363575-36357566.93967.39
6380311-38031170.02070.49
45min1358428-35842865.99167.972.7166.5568.542.70
2369498-36949868.03068.60
3384389-38438970.77171.34
4361532-36153266.56367.13
5363899-36389966.99967.56
6377336-37733669.47370.06
极限1366432-36643267.46567.702.3668.1368.392.34
2381115-38111570.16870.85
3362294-36229466.70367.39
4360387-36038766.35267.03
5360667-36066766.40467.08
6375511-37551169.13769.84
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%
117.454820234818684819014821194820194819860.03
217.594803914806124805020.04
单位质量响应值RSD%判断
27620.9727316.770.79数据可信
供试品溶液-2024041511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%
5min1377450-37745069.57967.713.0769.5867.713.07
2360702-36070266.49266.49
3371852-37185268.54768.55
4348188-34818864.18564.19
5368173-36817367.86967.87
6377359-37735969.56269.56
10min1371954-37195468.56668.432.5868.6868.552.58
2365738-36573867.42067.53
3376658-37665869.43369.55
4354970-35497065.43565.54
5377003-37700369.49769.61
6381104-38110470.25370.37
15min1369729-36972968.15668.173.3568.3968.403.35
2364985-36498567.28167.50
3375870-37587069.28869.52
4349331-34933164.39664.61
5372238-37223868.61868.85
6386591-38659171.26471.50
20min1370129-37012968.23067.912.2768.5768.252.28
2363619-36361967.03067.36
3374001-37400168.94369.29
4354774-35477465.39965.72
5369326-36932668.08268.42
6378629-37862969.79770.15
30min1367622-36762267.76767.352.8968.2367.812.89
2363323-36332366.97567.42
3373647-37364768.87869.34
4346146-34614663.80964.24
5365782-36578267.42867.89
6375731-37573169.26269.73
45min1363178-36317866.94866.992.0867.5267.552.09
2361926-36192666.71767.28
3364756-36475667.23967.81
4350335-35033564.58165.12
5366761-36676167.60968.18
6373353-37335368.82469.41
极限1361558-36155866.65066.591.9267.3367.261.92
2358678-35867866.11966.79
3367512-36751267.74768.43
4348920-34892064.32064.97
5363414-36341466.99267.67
6367248-36724867.69968.40
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%
117.454818894817514812354812444810504814340.08
217.594804674807634806150.05
单位质量响应值RSD%判断
27589.3427323.190.69数据可信
供试品溶液-2024051711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%
5min1317832-31783258.61659.161.2458.6259.161.24
2322643-32264359.50359.50
3327353-32735360.37260.37
4320402-32040259.09059.09
5315986-31598658.27558.28
6320416-32041659.09259.09
10min1307011-30701156.62059.322.6956.7259.422.69
2326621-32662160.23760.34
3330932-33093261.03261.13
4322705-32270559.51459.61
5316534-31653458.37658.47
6326262-32626260.17060.27
15min1304246-30424656.11059.092.7756.3059.292.77
2324038-32403859.76059.96
3329449-32944960.75860.96
4320576-32057659.12259.32
5318135-31813558.67258.87
6325940-32594060.11160.31
20min1324345-32434559.81759.701.4660.1059.991.46
2325500-32550060.03060.33
3330747-33074760.99761.30
4321409-32140959.27559.57
5316421-31642158.35558.65
6323745-32374559.70660.01
30min1304424-30442456.14359.303.0256.5359.703.01
2322611-32261159.49759.90
3329439-32943960.75661.16
4316650-31665058.39858.79
5327090-32709060.32360.71
6329202-32920260.71361.11
45min1304618-30461856.17958.652.5356.6659.142.52
2321831-32183159.35359.85
3327623-32762360.42160.93
4317381-31738158.53259.02
5314124-31412457.93258.42
6322476-32247659.47259.97
极限1300559-30055955.43057.952.4056.0058.542.40
2318265-31826558.69659.29
3321697-32169759.32859.94
4315528-31552858.19158.78
5311249-31124957.40257.99
6317957-31795758.63959.24
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%
117.454786354785924786844789624789404787630.04
217.594813554811954812750.03
单位质量响应值RSD%判断
27436.2827360.720.20数据可信
供试品溶液-2024051711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%
5min1321744-32174459.46156.123.6159.4656.123.61
2290095-29009553.61253.61
3302353-30235355.87755.88
4295249-29524954.56454.56
5305032-30503256.37256.37
6307532-30753256.83456.83
10min1324415-32441559.95557.182.7460.0557.272.74
2299301-29930155.31355.40
3305272-30527256.41756.51
4306117-30611756.57356.66
5310037-31003757.29757.39
6311285-31128557.52857.62
15min1323974-32397459.87356.972.9460.0757.162.93
2296381-29638154.77454.96
3305124-30512456.38956.58
4305654-30565456.48756.67
5308404-30840456.99657.19
6310073-31007357.30457.49
20min1323451-32345159.77656.812.8260.0857.092.82
2300297-30029755.49755.77
3300519-30051955.53855.82
4303379-30337956.06756.35
5307557-30755756.83957.12
6309097-30909757.12457.41
30min1320716-32071659.27156.682.4559.6757.062.45
2300169-30016955.47455.84
3301806-30180655.77656.15
4303280-30328056.04956.42
5305354-30535456.43256.81
6308767-30876757.06357.44
45min1321271-32127159.37456.572.6859.8757.042.67
2298644-29864455.19255.65
3301284-30128455.68056.15
4302803-30280355.96156.43
5303568-30356856.10256.58
6308921-30892157.09157.57
极限1329771-32977160.94456.134.3361.5456.704.31
2295422-29542254.59655.15
3300302-30030255.49856.06
4299418-29941855.33555.89
5294480-29448054.42254.99
6302847-30284755.96956.54
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