枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824744984737714754984747024733494743640.18
213.884777384762734770060.22
单位质量响应值RSD%判断
34324.4634366.430.09数据可信
加速6月-供试品溶液-2024041321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%
2min1248247-24824745.74841.5412.8445.7541.5412.85
2204405-20440537.66937.67
3177454-17745432.70232.70
4235020-23502043.31143.31
5252832-25283246.59346.59
6234395-23439543.19543.20
5min1363890-36389067.05961.597.2367.0661.597.23
2315409-31540958.12558.12
3310293-31029357.18257.18
4358913-35891366.14266.14
5313686-31368657.80757.81
6343133-34313363.23463.23
10min1339029-33902962.47859.235.1662.4859.245.15
2343616-34361663.32363.32
3319209-31920958.82558.83
4312665-31266557.61957.62
5301036-30103655.47655.48
6312981-31298157.67857.68
15min1311653-31165357.43359.342.5457.4359.342.55
2332785-33278561.32761.33
3325732-32573260.02760.03
4328080-32808060.46060.46
5314890-31489058.02958.03
6318966-31896658.78058.78
20min1343367-34336763.27760.932.9763.2860.932.97
2320115-32011558.99258.99
3342036-34203663.03263.03
4322766-32276659.48159.48
5328461-32846160.53060.53
6327150-32715060.28960.29
30min1336996-33699662.10361.112.1362.1061.112.13
2326059-32605960.08860.09
3340756-34075662.79662.80
4322392-32239259.41259.41
5334915-33491561.72061.72
6328487-32848760.53560.54
45min1337718-33771862.23660.032.8662.2460.032.86
2321588-32158859.26459.26
3332884-33288461.34561.35
4313152-31315257.70957.71
5319146-31914658.81458.81
6329971-32997160.80860.81
极限1338347-33834762.35260.973.6462.3560.973.64
2307036-30703656.58256.58
3335552-33555261.83761.84
4335168-33516861.76661.77
5338615-33861562.40162.40
6330352-33035260.87960.88
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824756184782064763444745814761024761700.28
213.884751064758844754950.12
单位质量响应值RSD%判断
34455.1434257.560.41数据可信
加速6月-供试品溶液-2024041121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%
2min1458211-45821184.41573.3911.3284.4173.3911.32
2386233-38623371.15571.15
3320641-32064159.07159.07
4412744-41274476.03976.04
5400656-40065673.81273.81
6411661-41166175.83975.84
5min1545031-545031100.41098.831.65100.4198.831.65
2538616-53861699.22899.23
3519366-51936695.68195.68
4539347-53934799.36299.36
5539345-53934599.36299.36
6537106-53710698.95098.95
10min1549131-549131101.165100.920.95101.16100.920.95
2556997-556997102.614102.61
3548761-548761101.097101.10
4545150-545150100.432100.43
5542673-54267399.97599.98
6544243-544243100.264100.26
15min1545754-545754100.543101.150.97100.54101.150.97
2557687-557687102.741102.74
3553740-553740102.014102.01
4545503-545503100.497100.50
5545655-545655100.525100.52
6545926-545926100.574100.57
20min1547226-547226100.814101.451.15100.81101.451.15
2559995-559995103.166103.17
3550613-550613101.438101.44
4556393-556393102.503102.50
5545914-545914100.572100.57
6544002-544002100.220100.22
30min1551488-551488101.599101.400.99101.60101.400.99
2559254-559254103.030103.03
3553135-553135101.903101.90
4544419-544419100.297100.30
5547202-547202100.810100.81
6546849-546849100.745100.74
45min1547447-547447100.855101.390.86100.85101.390.86
2557666-557666102.737102.74
3554708-554708102.192102.19
4546330-546330100.649100.65
5549310-549310101.198101.20
6546699-546699100.717100.72
极限1548927-548927101.127101.430.74101.13101.430.74
2557158-557158102.644102.64
3553793-553793102.024102.02
4546793-546793100.734100.73
5547769-547769100.914100.91
6548977-548977101.137101.14
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824741704728574748744730114722864734400.23
213.884748564758774753660.16
单位质量响应值RSD%判断
34257.6034248.270.02数据可信
加速6月-供试品溶液-2024041221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%
2min1288686-28868653.34460.235.6353.3460.225.63
2334900-33490061.88361.88
3335659-33565962.02462.02
4331902-33190261.33061.33
5333665-33366561.65561.66
6330774-33077461.12161.12
5min1534820-53482098.82596.222.0798.8396.222.07
2509718-50971894.18794.19
3512980-51298094.78994.79
4514954-51495495.15495.15
5533314-53331498.54798.55
6518680-51868095.84395.84
10min1553957-553957102.361101.220.98102.36101.220.99
2549437-549437101.526101.53
3550244-550244101.675101.68
4541707-541707100.098100.10
5550676-550676101.755101.76
6540583-54058399.89099.89
15min1551502-551502101.908101.450.48101.91101.440.48
2552530-552530102.098102.10
3549158-549158101.475101.47
4545749-545749100.845100.84
5547114-547114101.097101.10
6547963-547963101.254101.25
20min1555365-555365102.621101.830.84102.62101.830.84
2556329-556329102.800102.80
3551411-551411101.891101.89
4546774-546774101.034101.03
5551925-551925101.986101.99
6544680-544680100.647100.65
30min1552226-552226102.041101.600.66102.04101.600.66
2551353-551353101.880101.88
3552037-552037102.007102.01
4549909-549909101.613101.61
5550721-550721101.763101.76
6542682-542682100.278100.28
45min1554942-554942102.543101.860.74102.54101.860.74
2555137-555137102.579102.58
3551183-551183101.849101.85
4546568-546568100.996101.00
5553555-553555102.287102.29
6546152-546152100.919100.92
极限1550423-550423101.708101.480.46101.71101.490.46
2552371-552371102.068102.07
3549119-549119101.467101.47
4545860-545860100.865100.87
5550716-550716101.762101.76
6546803-546803101.039101.04
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824745994726354762444763764725634744830.40
213.884726904740144733520.20
单位质量响应值RSD%判断
34333.0734103.170.48数据可信
加速6月-供试品溶液-2024041321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%
2min1360160-36016066.62062.208.2366.6262.208.23
2294375-29437554.45154.45
3350403-35040364.81564.81
4364455-36445567.41467.41
5334238-33423861.82561.82
6313897-31389758.06258.06
5min1522921-52292196.72697.212.1996.7397.212.19
2505479-50547993.50093.50
3536777-53677799.28999.29
4531780-53178098.36498.36
5534197-53419798.81298.81
6522101-52210196.57496.57
10min1539954-53995499.876100.670.7399.88100.670.73
2539696-53969699.82999.83
3547938-547938101.353101.35
4544930-544930100.797100.80
5549246-549246101.595101.60
6543712-543712100.572100.57
15min1544481-544481100.714101.100.62100.71101.100.62
2544524-544524100.722100.72
3550930-550930101.907101.91
4545991-545991100.993100.99
5550520-550520101.831101.83
6542911-542911100.423100.42
20min1544869-544869100.786101.130.55100.79101.130.55
2543133-543133100.464100.46
3551221-551221101.961101.96
4546688-546688101.122101.12
5549201-549201101.587101.59
6545215-545215100.850100.85
30min1545453-545453100.894101.300.64100.89101.300.64
2543370-543370100.508100.51
3550436-550436101.815101.82
4547473-547473101.267101.27
5552965-552965102.283102.28
6546356-546356101.061101.06
45min1543706-543706100.570101.420.92100.57101.420.92
2542784-542784100.400100.40
3552954-552954102.281102.28
4547223-547223101.221101.22
5555466-555466102.746102.75
6547643-547643101.299101.30
极限1544485-544485100.715100.700.59100.71100.700.59
2541846-541846100.226100.23
3547381-547381101.250101.25
4543521-543521100.536100.54
5548748-548748101.503101.50
6540518-54051899.98199.98
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.824746984764794752034709974735674741890.44
213.884738964739424739190.01
单位质量响应值RSD%判断
34311.7934144.020.35数据可信
-供试品溶液-2024041121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%
2min1483947-48394789.49187.832.2789.4987.832.27
2468815-46881586.69286.69
3469681-46968186.85386.85
4468981-46898186.72386.72
5465764-46576486.12886.13
6492624-49262491.09591.10
5min1545636-545636100.898100.900.47100.90100.900.47
2544962-544962100.773100.77
3543040-543040100.418100.42
4548560-548560101.439101.44
5542970-542970100.405100.41
6548789-548789101.481101.48
10min1545842-545842100.936101.110.87100.94101.110.87
2539827-53982799.82499.82
3546593-546593101.075101.08
4547804-547804101.299101.30
5546095-546095100.983100.98
6554525-554525102.542102.54
15min1544768-544768100.738100.980.62100.74100.980.62
2542929-542929100.397100.40
3544461-544461100.681100.68
4546818-546818101.117101.12
5545166-545166100.811100.81
6552407-552407102.150102.15
20min1543207-543207100.449100.940.74100.45100.940.74
2541622-541622100.156100.16
3543747-543747100.549100.55
4549427-549427101.599101.60
5545174-545174100.813100.81
6552055-552055102.085102.09
30min1540300-54030099.911100.850.8699.91100.850.87
2541329-541329100.102100.10
3543678-543678100.536100.54
4549055-549055101.530101.53
5545377-545377100.850100.85
6552545-552545102.176102.18
45min1542948-542948100.401100.770.45100.40100.770.45
2541981-541981100.222100.22
3543923-543923100.581100.58
4547166-547166101.181101.18
5545546-545546100.881100.88
6548222-548222101.376101.38
极限1545317-545317100.839100.920.65100.84100.920.65
2542262-542262100.274100.27
3544460-544460100.681100.68
4547433-547433101.230101.23
5543080-543080100.425100.43
6551949-551949102.065102.07
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