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%
114.164857594863254857324863534853564859050.09
214.074835214836704835960.03
单位质量响应值RSD%判断
34315.3234370.720.12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%
2min1391228-39122872.10272.333.1872.1072.333.18
2392127-39212772.26872.27
3394058-39405872.62472.62
4389652-38965271.81271.81
5374345-37434568.99168.99
6413364-41336476.18276.18
5min1545799-545799100.58998.451.59100.5998.451.59
2537173-53717399.00099.00
3533008-53300898.23298.23
4519886-51988695.81495.81
5532441-53244198.12798.13
6536770-53677098.92598.93
10min1556025-556025102.474100.661.08102.47100.661.08
2547408-547408100.886100.89
3540648-54064899.64099.64
4539893-53989399.50199.50
5545385-545385100.513100.51
6547805-547805100.959100.96
15min1557732-557732102.789100.761.15102.79100.761.15
2548085-548085101.011101.01
3541067-54106799.71799.72
4540251-54025199.56799.57
5546481-546481100.715100.72
6546628-546628100.742100.74
20min1555471-555471102.372100.751.02102.37100.751.02
2546740-546740100.763100.76
3540386-54038699.59299.59
4541562-54156299.80899.81
5546216-546216100.666100.67
6549761-549761101.320101.32
30min1558042-558042102.846100.731.19102.85100.731.19
2547974-547974100.990100.99
3539896-53989699.50199.50
4542147-54214799.91699.92
5543307-543307100.130100.13
6547941-547941100.984100.98
45min1554716-554716102.233100.691.02102.23100.691.02
2548618-548618101.109101.11
3539098-53909899.35499.35
4542837-542837100.043100.04
5543870-543870100.234100.23
6548928-548928101.166101.17
极限1556519-556519102.565100.671.17102.57100.661.17
2548691-548691101.122101.12
3538553-53855399.25499.25
4541538-54153899.80499.80
5543787-543787100.219100.22
6548173-548173101.027101.03
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%
114.164853744853164860814857454853284855690.07
214.074852934858954855940.09
单位质量响应值RSD%判断
34291.6034512.720.46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%
2min1351637-35163764.69570.3812.9364.7070.3812.92
2328266-32826660.39560.40
3372413-37241368.51768.52
4464773-46477385.51085.51
5362916-36291666.77066.77
6415126-41512676.37676.38
5min1527079-52707996.97399.082.4296.9799.082.42
2525764-52576496.73196.73
3540967-54096799.52899.53
4559054-559054102.856102.86
5531340-53134097.75797.76
6547008-547008100.640100.64
10min1551739-551739101.510102.470.95101.51102.480.95
2556358-556358102.360102.36
3554685-554685102.052102.05
4566016-566016104.137104.14
5559865-559865103.005103.01
6553198-553198101.779101.78
15min1551312-551312101.432102.751.08101.43102.751.08
2557155-557155102.507102.51
3556333-556333102.355102.36
4567104-567104104.337104.34
5564181-564181103.799103.80
6554663-554663102.048102.05
20min1551931-551931101.546102.861.04101.55102.861.04
2557801-557801102.626102.63
3557554-557554102.580102.58
4566453-566453104.217104.22
5565519-565519104.046104.05
6555075-555075102.124102.12
30min1551183-551183101.408102.711.04101.41102.711.04
2557091-557091102.495102.49
3555632-555632102.226102.23
4565560-565560104.053104.05
5564984-564984103.947103.95
6555054-555054102.120102.12
45min1551611-551611101.487102.630.95101.49102.630.95
2556619-556619102.408102.41
3555163-555163102.140102.14
4565661-565661104.072104.07
5562693-562693103.526103.53
6555111-555111102.131102.13
极限1552501-552501101.650102.631.06101.65102.631.06
2557152-557152102.506102.51
3554690-554690102.053102.05
4566893-566893104.298104.30
5562960-562960103.575103.57
6552774-552774101.701101.70
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%
114.164840874843734842704834154842344840760.08
214.074860364869814865080.14
单位质量响应值RSD%判断
34186.1634577.680.81数据可信
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%
2min1364744-36474467.14763.7911.3967.1563.7911.39
2294995-29499554.30754.31
3409184-40918475.32975.33
4346610-34661063.80963.81
5346566-34656663.80163.80
6317030-31703058.36458.36
5min1541709-54170999.72695.813.1199.7395.823.11
2500477-50047792.13592.14
3532479-53247998.02798.03
4503360-50336092.66692.67
5520142-52014295.75595.76
6524495-52449596.55796.56
10min1549188-549188101.10399.661.26101.1099.661.26
2541767-54176799.73699.74
3539020-53902099.23199.23
4549449-549449101.151101.15
5535217-53521798.53198.53
6533499-53349998.21498.21
15min1549645-549645101.18799.961.69101.1999.961.69
2543694-543694100.091100.09
3538401-53840199.11799.12
4557273-557273102.591102.59
5535823-53582398.64298.64
6533202-53320298.16098.16
20min1548206-548206100.92299.821.76100.9299.821.76
2541420-54142099.67399.67
3539191-53919199.26299.26
4557931-557931102.712102.71
5534343-53434398.37098.37
6532297-53229797.99397.99
30min1551801-551801101.584100.131.76101.58100.131.76
2542154-54215499.80899.81
3540391-54039199.48399.48
4558602-558602102.836102.84
5537918-53791899.02899.03
6532622-53262298.05398.05
45min1549701-549701101.197100.131.68101.20100.141.67
2542269-54226999.82999.83
3540028-54002899.41699.42
4559177-559177102.942102.94
5538295-53829599.09799.10
6534047-53404798.31598.32
极限1549858-549858101.226100.251.76101.23100.241.76
2545152-545152100.360100.36
3540665-54066599.53499.53
4560327-560327103.153103.15
5536855-53685598.83298.83
6534334-53433498.36898.37
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%
114.164850584847924848504849044849134849030.03
214.074883224872944878080.15
单位质量响应值RSD%判断
34244.5634670.080.88数据可信
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%
2min1353145-35314564.87065.148.3864.8765.148.38
2303700-30370055.78855.79
3356954-35695465.57065.57
4395923-39592372.72872.73
5353100-35310064.86264.86
6364694-36469466.99266.99
5min1518153-51815395.18195.042.6995.1895.042.69
2490712-49071290.14090.14
3518178-51817895.18695.19
4528109-52810997.01097.01
5520611-52061195.63395.63
6528605-52860597.10197.10
10min1527296-52729696.86198.671.1796.8698.661.17
2534919-53491998.26198.26
3545767-545767100.254100.25
4539436-53943699.09199.09
5535151-53515198.30398.30
6540192-54019299.22999.23
15min1526249-52624996.66898.861.2996.6798.861.29
2540261-54026199.24299.24
3547282-547282100.532100.53
4540933-54093399.36699.37
5537027-53702798.64898.65
6537166-53716698.67498.67
20min1527116-52711696.82798.881.2296.8398.881.22
2539727-53972799.14499.14
3546303-546303100.352100.35
4542022-54202299.56699.57
5535599-53559998.38698.39
6539071-53907199.02499.02
30min1528279-52827997.04198.771.0397.0498.771.03
2538945-53894599.00099.00
3544012-54401299.93199.93
4540628-54062899.31099.31
5534770-53477098.23398.23
6539459-53945999.09599.09
45min1526620-52662096.73698.621.1496.7498.621.14
2538546-53854698.92798.93
3545117-545117100.134100.13
4539253-53925399.05799.06
5534879-53487998.25498.25
6536913-53691398.62798.63
极限1526427-52642796.70198.681.1996.7098.681.19
2539020-53902099.01499.01
3544666-544666100.051100.05
4540026-54002699.19999.20
5533494-53349497.99998.00
6539467-53946799.09699.10
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