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%
114.164933244928774926634924064925444927630.08
214.074892844894234893540.03
单位质量响应值RSD%判断
34799.6534779.960.05数据可信
供试品溶液-2024041121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1296317-29631753.90965.4413.5853.9165.4413.58
2324239-32423958.98958.99
3330640-33064060.15460.15
4395647-39564771.98071.98
5394115-39411571.70271.70
6417389-41738975.93675.94
5min1504528-50452891.78998.194.7891.7998.184.78
2516560-51656093.97893.98
3537203-53720397.73497.73
4552411-552411100.500100.50
5552924-552924100.594100.59
6574483-574483104.516104.52
10min1556863-556863101.310102.051.09101.31102.051.09
2558821-558821101.667101.67
3561735-561735102.197102.20
4557071-557071101.348101.35
5558290-558290101.570101.57
6572819-572819104.213104.21
15min1558252-558252101.563102.171.04101.56102.161.05
2560158-560158101.910101.91
3562101-562101102.263102.26
4556754-556754101.291101.29
5559216-559216101.738101.74
6572889-572889104.226104.23
20min1557296-557296101.389102.091.03101.39102.101.03
2559090-559090101.716101.72
3563387-563387102.497102.50
4557389-557389101.406101.41
5557888-557888101.497101.50
6571942-571942104.054104.05
30min1556746-556746101.289102.101.09101.29102.101.08
2559786-559786101.842101.84
3562513-562513102.338102.34
4557290-557290101.388101.39
5558036-558036101.524101.52
6572817-572817104.213104.21
45min1557229-557229101.377102.030.98101.38102.030.98
2559604-559604101.809101.81
3563098-563098102.445102.44
4556364-556364101.220101.22
5557703-557703101.463101.46
6570799-570799103.846103.85
极限1555954-555954101.145101.941.07101.14101.941.07
2558656-558656101.637101.64
3562008-562008102.246102.25
4555269-555269101.020101.02
5558563-558563101.620101.62
6571461-571461103.966103.97
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%
114.164922824911314912704906374905844911810.14
214.074930004934764932380.07
单位质量响应值RSD%判断
34687.9235056.010.75数据可信
供试品溶液-2024041121批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1297887-29788754.06965.2115.7154.0765.2115.71
2415553-41555375.42675.43
3368085-36808566.81066.81
4316194-31619457.39157.39
5322853-32285358.60058.60
6434928-43492878.94278.94
5min1515295-51529593.53096.403.8693.5396.403.86
2546620-54662099.21599.22
3549727-54972799.77999.78
4518796-51879694.16594.17
5504810-50481091.62691.63
6551421-551421100.087100.09
10min1555184-555184100.770100.140.87100.77100.140.87
2552856-552856100.347100.35
3554718-554718100.685100.69
4546360-54636099.16899.17
5545148-54514898.94898.95
6556061-556061100.929100.93
15min1554466-554466100.639100.491.27100.64100.491.26
2553057-553057100.384100.38
3554757-554757100.692100.69
4546885-54688599.26399.26
5546916-54691699.26999.27
6565896-565896102.714102.71
20min1557181-557181101.132100.440.62101.13100.440.62
2552404-552404100.265100.27
3554854-554854100.710100.71
4552846-552846100.345100.35
5547380-54738099.35399.35
6555495-555495100.826100.83
30min1555123-555123100.759100.190.65100.76100.190.65
2551802-551802100.156100.16
3554550-554550100.655100.65
4548057-54805799.47699.48
5547241-54724199.32899.33
6555031-555031100.742100.74
45min1555677-555677100.859100.230.73100.86100.230.73
2553097-553097100.391100.39
3554076-554076100.569100.57
4547146-54714699.31199.31
5547302-54730299.33999.34
6555841-555841100.889100.89
极限1559175-559175101.494100.370.79101.49100.370.79
2553022-553022100.377100.38
3553177-553177100.405100.41
4546550-54655099.20399.20
5550331-55033199.88999.89
6555627-555627100.850100.85
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%
114.164907624909004905064902664905754906020.05
214.074897144897134897140.01
单位质量响应值RSD%判断
34647.0334805.540.33数据可信
供试品溶液-2024041321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1309545-30954556.41971.5012.6756.4271.5012.67
2436741-43674179.60279.60
3395762-39576272.13372.13
4445786-44578681.25181.25
5367556-36755666.99266.99
6398255-39825572.58872.59
5min1517218-51721894.27095.722.2494.2795.722.24
2538867-53886798.21698.22
3530569-53056996.70496.70
4531806-53180696.92996.93
5506098-50609892.24492.24
6526539-52653995.96995.97
10min1536185-53618597.72798.080.4097.7398.080.39
2539718-53971898.37198.37
3540099-54009998.44198.44
4538521-53852198.15398.15
5539372-53937298.30898.31
6534942-53494297.50197.50
15min1537516-53751697.97098.490.4997.9798.490.49
2542348-54234898.85198.85
3542603-54260398.89798.90
4538991-53899198.23998.24
5543173-54317399.00199.00
6537548-53754897.97697.98
20min1537890-53789098.03898.560.5098.0498.560.50
2541961-54196198.78098.78
3543657-54365799.08999.09
4540822-54082298.57298.57
5542905-54290598.95298.95
6537204-53720497.91397.91
30min1541331-54133198.66598.930.3898.6798.930.38
2543983-54398399.14999.15
3541025-54102598.60998.61
4543720-54372099.10199.10
5545797-54579799.47999.48
6540856-54085698.57998.58
45min1541197-54119798.64199.160.3998.6499.160.39
2545261-54526199.38299.38
3546496-54649699.60799.61
4543168-54316899.00099.00
5545671-54567199.45699.46
6542450-54245098.86998.87
极限1544759-54475999.29099.510.4699.2999.510.46
2549579-549579100.169100.17
3543832-54383299.12199.12
4547406-54740699.77399.77
5547287-54728799.75199.75
6543047-54304798.97898.98
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%
114.164887404889294892374891444894224890940.06
214.074898954896404897680.04
单位质量响应值RSD%判断
34540.5434809.380.55数据可信
供试品溶液-2024041321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1375412-37541268.52672.135.6568.5372.135.65
2421117-42111776.86976.87
3368354-36835467.23867.24
4385763-38576370.41670.42
5401015-40101573.20073.20
6419272-41927276.53276.53
5min1536838-53683897.99295.941.3397.9995.941.33
2527184-52718496.23096.23
3529360-52936096.62796.63
4520206-52020694.95694.96
5522146-52214695.31095.31
6517889-51788994.53394.53
10min1548002-548002100.03098.710.90100.0398.700.90
2533860-53386097.44997.45
3543971-54397199.29499.29
4541065-54106598.76498.76
5538700-53870098.33298.33
6538877-53887798.36498.36
15min1549340-549340100.27498.691.09100.2798.691.09
2535965-53596597.83397.83
3544739-54473999.43499.43
4533119-53311997.31397.31
5541054-54105498.76298.76
6539820-53982098.53698.54
20min1547978-547978100.02698.830.80100.0398.830.81
2535906-53590697.82297.82
3544668-54466899.42199.42
4538913-53891398.37198.37
5539553-53955398.48898.49
6541574-54157498.85798.86
30min1550329-550329100.45599.361.16100.4599.351.16
2537006-53700698.02398.02
3545315-54531599.53999.54
4539068-53906898.39998.40
5552734-552734100.894100.89
6541398-54139898.82598.82
45min1550438-550438100.47599.031.00100.4799.031.00
2538345-53834598.26798.27
3545917-54591799.64999.65
4535237-53523797.70097.70
5541896-54189698.91598.92
6543247-54324799.16299.16
极限1553491-553491101.03299.560.93101.0399.560.93
2539302-53930298.44298.44
3548335-548335100.091100.09
4541805-54180598.89998.90
5545573-54557399.58799.59
6544067-54406799.31299.31
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