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%
114.164863604857614857394860674850954858040.10
214.074857694858614858150.02
单位质量响应值RSD%判断
34308.1934528.430.46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%
2min1530362-53036297.53198.121.4197.5398.121.42
2530641-53064197.58397.58
3527588-52758897.02197.02
4526740-52674096.86596.87
5543053-54305399.86599.87
6543122-54312299.87899.88
5min1539214-53921499.15998.280.6399.1698.280.63
2538173-53817398.96898.97
3533068-53306898.02998.03
4532010-53201097.83597.83
5532249-53224997.87897.88
6531918-53191897.81897.82
10min1554918-554918102.047100.571.23102.05100.571.23
2554031-554031101.884101.88
3546827-546827100.559100.56
4546578-546578100.514100.51
5539204-53920499.15799.16
6539791-53979199.26599.27
15min1536057-53605798.57999.860.9998.5899.860.99
2536371-53637198.63698.64
3545765-545765100.364100.36
4545318-545318100.282100.28
5547322-547322100.650100.65
6547370-547370100.659100.66
20min1543327-54332799.916101.141.4499.92101.141.44
2542401-54240199.74599.75
3547275-547275100.642100.64
4547070-547070100.604100.60
5559818-559818102.948102.95
6559880-559880102.960102.96
30min1557496-557496102.521102.570.56102.52102.570.55
2558029-558029102.619102.62
3554052-554052101.888101.89
4554652-554652101.998102.00
5560913-560913103.150103.15
6561470-561470103.252103.25
45min1549947-549947101.13399.860.99101.1399.860.99
2549698-549698101.087101.09
3540960-54096099.48099.48
4539635-53963599.23799.24
5539250-53925099.16699.17
6538583-53858399.04399.04
极限1548588-548588100.88399.021.47100.8899.021.46
2548460-548460100.860100.86
3535157-53515798.41398.41
4532525-53252597.92997.93
5533110-53311098.03798.04
6532822-53282297.98497.98
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%
114.164859994854224855104856224859684857040.06
214.074859054851924855480.11
单位质量响应值RSD%判断
34301.1334509.450.43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%
2min1530074-53007497.51597.110.3997.5297.110.39
2529648-52964897.43797.44
3526122-52612296.78896.79
4524950-52495096.57396.57
5528745-52874597.27197.27
6527769-52776997.09197.09
5min1536323-53632398.66598.820.8798.6698.820.88
2537566-53756698.89498.89
3542086-54208699.72599.73
4542799-54279999.85699.86
5532168-53216897.90197.90
6531941-53194197.85997.86
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
114.164865134852484867734859394855554860060.14
214.074863394857894860640.09
单位质量响应值RSD%判断
34322.4634546.130.46数据可信
供试品溶液-2024041321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%
2min1324138-32413859.58058.067.5259.5858.067.52
2276304-27630450.78850.79
3299914-29991455.12755.13
4322516-32251659.28259.28
5330672-33067260.78160.78
6341669-34166962.80262.80
5min1499099-49909991.74092.123.8291.7492.123.82
2475087-47508787.32687.33
3487148-48714889.54389.54
4505362-50536292.89192.89
5509874-50987493.72093.72
6530403-53040397.49497.49
10min1533583-53358398.07897.341.5798.0897.341.57
2535612-53561298.45198.45
3516663-51666394.96894.97
4525293-52529396.55496.55
5526801-52680196.83296.83
6539559-53955999.17799.18
15min1534284-53428498.20798.041.6598.2198.041.65
2539184-53918499.10899.11
3532796-53279697.93497.93
4525320-52532096.55996.56
5522517-52251796.04496.04
6546274-546274100.411100.41
20min1532422-53242297.86598.381.5997.8698.381.59
2540624-54062499.37299.37
3531611-53161197.71697.72
4524280-52428096.36896.37
5533679-53367998.09698.10
6548853-548853100.885100.89
30min1535618-53561898.45298.521.9398.4598.521.93
2540713-54071399.38999.39
3532745-53274597.92497.92
4525319-52531996.55996.56
5527700-52770096.99797.00
6553802-553802101.795101.79
45min1536774-53677498.66598.501.0298.6698.501.02
2540136-54013699.28399.28
3531896-53189697.76897.77
4528032-52803297.05897.06
5535300-53530098.39498.39
6543004-54300499.81099.81
极限1529729-52972997.37098.580.8897.3798.580.88
2538861-53886199.04899.05
3535662-53566298.46098.46
4532029-53202997.79397.79
5541396-54139699.51499.51
6540151-54015199.28699.29
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%
114.164845054844714841404838214845994843070.07
214.074871704868734870220.05
单位质量响应值RSD%判断
34202.4734614.210.85数据可信
供试品溶液-2024041321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%
2min1396652-39665272.96659.6014.4972.9759.6014.50
2327554-32755460.25560.25
3358958-35895866.03266.03
4273310-27331050.27650.28
5286341-28634152.67452.67
6301216-30121655.41055.41
5min1526760-52676096.90093.832.6296.9093.842.62
2519965-51996595.65095.65
3513438-51343894.44994.45
4497169-49716991.45691.46
5491761-49176190.46190.46
6511482-51148294.08994.09
10min1537325-53732598.84398.071.3898.8498.071.38
2539103-53910399.17099.17
3523638-52363896.32596.33
4525650-52565096.69596.70
5531699-53169997.80897.81
6541323-54132399.57999.58
15min1539455-53945599.23598.721.4899.2398.721.48
2540122-54012299.35899.36
3524263-52426396.44096.44
4531610-53161097.79297.79
5537154-53715498.81298.81
6547266-547266100.672100.67
20min1537773-53777398.92598.901.1198.9398.891.11
2542661-54266199.82599.82
3527740-52774097.08097.08
4535039-53503998.42398.42
5537980-53798098.96498.96
6544455-544455100.155100.15
30min1541175-54117599.55199.121.2799.5599.121.27
2543751-543751100.025100.03
3528257-52825797.17597.17
4533970-53397098.22698.23
5538805-53880599.11599.12
6547116-547116100.644100.64
45min1540147-54014799.36298.811.3499.3698.811.34
2543037-54303799.89499.89
3525721-52572196.70896.71
4533325-53332598.10798.11
5535361-53536198.48298.48
6545206-545206100.293100.29
极限1541802-54180299.66799.031.2699.6799.031.26
2542901-54290199.86999.87
3527742-52774297.08097.08
4533560-53356098.15098.15
5537887-53788798.94698.95
6546162-546162100.469100.47
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%
114.164859354867344861184863874858334862010.08
214.074856604858334857460.03
单位质量响应值RSD%判断
34336.2334523.530.39数据可信
供试品溶液批-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%
2min1352007-35200764.71164.086.1864.7164.086.18
2388293-38829371.38171.38
3336711-33671161.89961.90
4327558-32755860.21660.22
5336563-33656361.87261.87
6350320-35032064.40164.40
5min1521688-52168895.90494.341.5195.9094.341.50
2521824-52182495.92995.93
3511713-51171394.07094.07
4514495-51449594.58294.58
5503823-50382392.62092.62
6505548-50554892.93792.94
10min1537023-53702398.72397.651.7298.7297.651.72
2541518-54151899.54999.55
3532364-53236497.86697.87
4536172-53617298.56698.57
5519906-51990695.57695.58
6520225-52022595.63595.63
15min1540216-54021699.31098.291.1499.3198.291.14
2542046-54204699.64699.65
3533146-53314698.01098.01
4536819-53681998.68598.69
5527624-52762496.99597.00
6528065-52806597.07697.08
20min1539422-53942299.16498.401.2499.1698.401.23
2543035-54303599.82899.83
3536511-53651198.62998.63
4538109-53810998.92398.92
5526446-52644696.77996.78
6528070-52807097.07797.08
30min1539281-53928199.13898.661.2099.1498.661.20
2544177-544177100.038100.04
3538691-53869199.03099.03
4540348-54034899.33499.33
5530079-53007997.44697.45
6527586-52758696.98896.99
45min1538012-53801298.90598.380.7598.9098.380.75
2534147-53414798.19498.19
3536500-53650098.62798.63
4540521-54052199.36699.37
5532143-53214397.82697.83
6529546-52954697.34897.35
极限1540184-54018499.30498.561.0299.3098.561.01
2542302-54230299.69399.69
3537454-53745498.80298.80
4537647-53764798.83898.84
5528185-52818597.09897.10
6531109-53110997.63697.64
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%
114.164850304842374849954843064848414846820.08
214.074839494836014837750.06
单位质量响应值RSD%判断
34228.9534383.440.32数据可信
供试品溶液批-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%
2min1350924-35092464.74462.3513.7364.7462.3613.73
2324171-32417159.80859.81
3419725-41972577.43877.44
4282199-28219952.06552.06
5313429-31342957.82657.83
6337389-33738962.24762.25
5min1512387-51238794.53393.273.0194.5393.273.01
2498246-49824691.92491.92
3522313-52231396.36596.36
4485790-48579089.62689.63
5493452-49345291.04091.04
6520961-52096196.11596.12
10min1535057-53505798.71698.460.6198.7298.460.61
2527662-52766297.35297.35
3535759-53575998.84598.85
4536144-53614498.91698.92
5532500-53250098.24498.24
6534948-53494898.69698.70
15min1539879-53987999.60699.340.8699.6199.340.85
2529797-52979797.74597.75
3538936-53893699.43299.43
4543649-543649100.301100.30
5539131-53913199.46899.47
6539095-53909599.46199.46
20min1538619-53861999.37399.520.7799.3799.510.77
2532222-53222298.19398.19
3540070-54007099.64199.64
4543598-543598100.292100.29
5538696-53869699.38799.39
6543126-543126100.205100.20
30min1538536-53853699.35899.430.5999.3699.430.59
2533881-53388198.49998.50
3539222-53922299.48499.48
4543225-543225100.223100.22
5537719-53771999.20799.21
6540953-54095399.80499.80
45min1537313-53731399.13299.230.9399.1399.240.93
2528130-52813097.43897.44
3539445-53944599.52599.53
4540589-54058999.73799.74
5541557-54155799.91599.92
6540172-54017299.66099.66
极限1536049-53604998.89999.270.4898.9099.270.48
2533857-53385798.49598.49
3538764-53876499.40099.40
4540303-54030399.68499.68
5539575-53957599.54999.55
6539755-53975599.58399.58
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