盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973768173768583767823769263767783768320.02
211.823742153743353742750.03
单位质量响应值RSD%判断
31481.3731664.550.42数据可信
影响因素30天包装高温-供试品溶液-2023120221批-0.1mol/L盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1311059-31105974.67780.784.0874.6880.784.07
2337128-33712880.93580.94
3337659-33765981.06381.06
4352188-35218884.55184.55
5337859-33785981.11181.11
6342936-34293682.33082.33
5min1381257-38125791.52995.052.4091.5395.052.40
2393456-39345694.45894.46
3392957-39295794.33894.34
4396785-39678595.25795.26
5409754-40975498.37198.37
6401215-40121596.32196.32
10min1387755-38775593.08996.332.3593.0996.332.35
2398517-39851795.67395.67
3399416-39941695.88995.89
4399263-39926395.85295.85
5416029-41602999.87799.88
6406503-40650397.59097.59
15min1391033-39103393.87696.712.2993.8896.712.29
2402029-40202996.51696.52
3402429-40242996.61296.61
4399882-39988296.00196.00
5419403-419403100.687100.69
6402279-40227996.57696.58
20min1392979-39297994.34397.552.6894.3497.552.68
2403823-40382396.94796.95
3403810-40381096.94496.94
4400861-40086196.23696.24
5424755-424755101.972101.97
6411836-41183698.87198.87
30min1394736-39473694.76597.702.2894.7797.702.27
2405792-40579297.42097.42
3405829-40582997.42897.43
4401706-40170696.43996.44
5421993-421993101.309101.31
6411601-41160198.81498.81
45min1396505-39650595.19097.922.2595.1997.922.25
2406918-40691897.69097.69
3407600-40760097.85497.85
4401656-40165696.42796.43
5423296-423296101.622101.62
6411190-41119098.71598.72
极限1397349-39734995.39398.162.2795.3998.162.27
2409626-40962698.34098.34
3407947-40794797.93797.94
4402870-40287096.71896.72
5424827-424827101.989101.99
6410688-41068898.59598.59
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973761853763133762583761863762383762360.02
211.823752723754093753400.03
单位质量响应值RSD%判断
31431.5831754.650.73数据可信
影响因素30天包装高湿-供试品溶液-2023120221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1370701-37070188.94087.524.4888.9487.524.48
2362656-36265687.01087.01
3358030-35803085.90085.90
4392725-39272594.22494.22
5343450-34345082.40282.40
6361182-36118286.65686.66
5min1412248-41224898.90897.691.5498.9197.691.54
2408406-40840697.98697.99
3403127-40312796.72096.72
4416310-41631099.88399.88
5400336-40033696.05096.05
6402517-40251796.57396.57
10min1411526-41152698.73598.151.2098.7398.151.20
2409220-40922098.18298.18
3405114-40511497.19697.20
4416821-416821100.005100.01
5402865-40286596.65796.66
6409063-40906398.14498.14
15min1411696-41169698.77698.021.1698.7898.021.16
2409252-40925298.18998.19
3404302-40430297.00297.00
4415522-41552299.69499.69
5402729-40272996.62496.62
6407780-40778097.83697.84
20min1410698-41069898.53697.961.2398.5497.961.23
2409479-40947998.24498.24
3405249-40524997.22997.23
4416499-41649999.92899.93
5402554-40255496.58296.58
6405397-40539797.26497.26
30min1413070-41307099.10598.391.0799.1198.381.08
2410349-41034998.45298.45
3406467-40646797.52197.52
4416795-41679599.999100.00
5404835-40483597.12997.13
6408899-40889998.10598.10
45min1412477-41247798.96398.301.1798.9698.301.17
2409715-40971598.30098.30
3406185-40618597.45397.45
4417042-417042100.058100.06
5403391-40339196.78396.78
6409458-40945898.23998.24
极限1411359-41135998.69598.331.1598.6998.331.14
2408613-40861398.03698.04
3405317-40531797.24597.25
4418108-418108100.314100.31
5405734-40573497.34597.35
6409949-40994998.35698.36
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973799983804213823223804463807073807790.24
211.823781333786333783830.10
单位质量响应值RSD%判断
31811.1132012.100.45数据可信
影响因素30天包装光照-供试品溶液-2023120221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1349783-34978383.08276.4911.6883.0876.4911.68
2363259-36325986.28386.28
3321860-32186076.45076.45
4255981-25598160.80260.80
5331504-33150478.74178.74
6309837-30983773.59473.59
5min1417152-41715299.08496.621.6899.0896.621.68
2413049-41304998.11098.11
3401994-40199495.48495.48
4402968-40296895.71595.72
5405573-40557396.33496.33
6399894-39989494.98594.98
10min1418773-41877399.46998.211.1299.4798.211.12
2414276-41427698.40198.40
3414144-41414498.37098.37
4407729-40772996.84696.85
5408272-40827296.97596.97
6417658-41765899.20499.20
15min1421183-421183100.04298.331.16100.0498.341.16
2415178-41517898.61598.62
3416802-41680299.00199.00
4407915-40791596.89096.89
5410124-41012497.41597.41
6412782-41278298.04698.05
20min1420128-42012899.79198.591.4899.7998.591.48
2422942-422942100.459100.46
3417556-41755699.18099.18
4407067-40706796.68996.69
5412698-41269898.02698.03
6410072-41007297.40297.40
30min1418174-41817499.32798.500.8899.3398.500.88
2416036-41603698.81998.82
3419138-41913899.55699.56
4410193-41019397.43197.43
5413196-41319698.14498.14
6411518-41151897.74697.75
45min1420651-42065199.91598.721.1899.9298.721.19
2418524-41852499.41099.41
3420047-42004799.77299.77
4410109-41010997.41197.41
5414657-41465798.49298.49
6409656-40965697.30497.30
极限1418148-41814899.32198.530.9799.3298.530.97
2415817-41581798.76798.77
3420464-42046499.87199.87
4410083-41008397.40597.41
5412134-41213497.89297.89
6412238-41223897.91797.92
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973831413805543805063801583794913807700.37
211.823781693779513780600.05
单位质量响应值RSD%判断
31810.3631984.770.39数据可信
加速1月-供试品溶液-2023120221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1401284-40128495.35791.673.7095.3691.673.70
2385003-38500391.48891.49
3382826-38282690.97190.97
4401182-40118295.33395.33
5363281-36328186.32686.33
6381030-38103090.54490.54
5min1428633-428633101.85699.412.31101.8699.412.32
2400514-40051495.17495.17
3421640-421640100.194100.19
4423794-423794100.706100.71
5416978-41697899.08699.09
6418439-41843999.43399.43
10min1426652-426652101.38599.712.32101.3899.712.32
2400232-40023295.10795.11
3421376-421376100.131100.13
4424790-424790100.943100.94
5421385-421385100.133100.13
6423181-423181100.560100.56
15min1425969-425969101.22399.442.43101.2299.442.43
2398150-39815094.61294.61
3423482-423482100.632100.63
4420651-42065199.95999.96
5421595-421595100.183100.18
6420903-420903100.019100.02
20min1427032-427032101.47599.742.35101.4899.742.35
2400577-40057795.18995.19
3422859-422859100.484100.48
4426804-426804101.421101.42
5419126-41912699.59799.60
6421877-421877100.250100.25
30min1427593-427593101.60999.502.50101.6199.502.50
2398340-39834094.65794.66
3422921-422921100.498100.50
4424479-424479100.869100.87
5418736-41873699.50499.50
6420275-42027599.87099.87
45min1426431-426431101.33299.452.30101.3399.462.30
2399825-39982595.01095.01
3423425-423425100.618100.62
4423190-423190100.562100.56
5418166-41816699.36899.37
6420145-42014599.83999.84
极限1426061-426061101.24599.582.26101.2499.582.26
2400395-40039595.14695.15
3423372-423372100.606100.61
4424376-424376100.844100.84
5420447-42044799.91099.91
6419778-41977899.75299.75
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973794693800723824723809243811183808110.30
211.823811083781453796260.56
单位质量响应值RSD%判断
31813.7832117.260.68数据可信
加速1月-供试品溶液-2023120521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1368399-36839987.35887.142.7787.3687.142.77
2361807-36180785.79485.79
3385936-38593691.51691.52
4361326-36132685.68085.68
5357541-35754184.78384.78
6369765-36976587.68187.68
5min1421596-42159699.97297.781.5299.9797.781.52
2404045-40404595.81095.81
3410365-41036597.30997.31
4411388-41138897.55197.55
5409334-40933497.06497.06
6417474-41747498.99598.99
10min1419469-41946999.46897.861.4999.4797.861.49
2402760-40276095.50695.51
3410635-41063597.37397.37
4413027-41302797.94097.94
5411488-41148897.57597.58
6418823-41882399.31499.31
15min1420857-42085799.79798.081.3699.8098.081.36
2405468-40546896.14896.15
3414096-41409698.19498.19
4412129-41212997.72797.73
5410573-41057397.35897.36
6418672-41867299.27999.28
20min1420853-42085399.79698.021.5299.8098.021.52
2404274-40427495.86595.86
3411489-41148997.57597.58
4412808-41280897.88897.89
5410688-41068897.38597.39
6420097-42009799.61799.62
30min1425183-425183100.82398.231.88100.8298.231.88
2403183-40318395.60695.61
3413894-41389498.14698.15
4413029-41302997.94197.94
5409766-40976697.16797.17
6420459-42045999.70299.70
45min1424442-424442100.64798.141.69100.6598.141.69
2404690-40469095.96395.96
3411435-41143597.56397.56
4414083-41408398.19198.19
5409768-40976897.16797.17
6418725-41872599.29199.29
极限1421653-42165399.98698.311.5399.9998.311.53
2406770-40677096.45696.46
3409376-40937697.07497.07
4414381-41438198.26198.26
5412977-41297797.92897.93
6422323-422323100.144100.14
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973825173830803821283821863816633823150.14
211.823778543793653786100.29
单位质量响应值RSD%判断
31939.4332031.300.21数据可信
加速1月-供试品溶液-2023120621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1357948-35794884.82585.681.5284.8285.671.52
2369740-36974087.61987.62
3355281-35528184.19384.19
4366003-36600386.73486.73
5358270-35827084.90184.90
6361974-36197485.77985.78
5min1401765-40176595.20997.601.8795.2197.601.87
2415621-41562198.49298.49
3402474-40247495.37795.38
4416155-41615598.61998.62
5415406-41540698.44198.44
6419603-41960399.43699.44
10min1409495-40949597.04098.011.3597.0498.021.35
2416028-41602898.58898.59
3404124-40412495.76895.77
4416398-41639898.67698.68
5418047-41804799.06799.07
6417504-41750498.93898.94
15min1410070-41007097.17798.331.4997.1898.331.49
2418292-41829299.12599.13
3404766-40476695.92095.92
4416833-41683398.77998.78
5420025-42002599.53699.54
6419615-41961599.43999.44
20min1411997-41199797.63398.351.3597.6398.351.35
2415442-41544298.45098.45
3405652-40565296.13096.13
4417239-41723998.87598.88
5421754-42175499.94599.95
6417986-41798699.05299.05
30min1415823-41582398.54098.551.0598.5498.551.05
2417742-41774298.99598.99
3407369-40736996.53796.54
4416540-41654098.71098.71
5419304-41930499.36599.36
6418430-41843099.15899.16
45min1415299-41529998.41698.450.8498.4298.450.84
2416375-41637598.67198.67
3409192-40919296.96996.97
4415919-41591998.56398.56
5419942-41994299.51699.52
6415846-41584698.54598.55
极限1419275-41927599.35898.391.3199.3698.391.31
2416092-41609298.60498.60
3406075-40607596.23096.23
4416951-41695198.80798.81
5420840-42084099.72999.73
6411958-41195897.62497.62
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