枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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250
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%
117.254769344771104770094763314768194768410.07
217.214775964773334774640.04
单位质量响应值RSD%判断
27642.9627743.400.26数据可信
供试品溶液-2022051601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%
5min1518979-51897994.89196.011.6194.8996.011.62
2523000-52300095.62695.63
3539735-53973598.68698.69
4529016-52901696.72696.73
5524025-52402595.81495.81
6515933-51593394.33494.33
10min1519360-51936094.96196.241.4695.1296.401.46
2526767-52676796.31596.47
3539240-53924098.59698.76
4527387-52738796.42996.59
5527712-52771296.48896.65
6517663-51766394.65194.81
15min1516605-51660594.45795.781.5794.7796.101.57
2519708-51970895.02495.34
3538652-53865298.48898.82
4524826-52482695.96096.28
5525743-52574396.12896.45
6517380-51738094.59994.91
20min1516012-51601294.34995.641.5494.8296.121.54
2519065-51906594.90795.39
3536482-53648298.09198.58
4525837-52583796.14596.63
5525736-52573696.12796.61
6515256-51525694.21094.68
30min1515299-51529994.21895.601.5194.8596.241.51
2521244-52124495.30595.94
3535898-53589897.98598.64
4526652-52665296.29496.94
5523346-52334695.69096.33
6514774-51477494.12294.75
45min1515094-51509494.18195.511.4094.9796.301.39
2521978-52197895.44096.23
3533383-53338397.52598.34
4525548-52554896.09296.89
5524353-52435395.87496.67
6513682-51368293.92394.71
极限1513057-51305793.80895.301.4494.7596.261.44
2521566-52156695.36496.32
3533614-53361497.56798.55
4522618-52261895.55796.52
5522735-52273595.57896.54
6513732-51373293.93294.87
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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250
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%
117.254777014774484782834766784777704775760.13
217.214783364780014781680.05
单位质量响应值RSD%判断
27685.5727784.310.26数据可信
供试品溶液-2022051602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%
5min1509547-50954793.02694.641.1793.0394.641.17
2515375-51537594.09094.09
3526338-52633896.09296.09
4518884-51888494.73194.73
5523648-52364895.60195.60
6516562-51656294.30794.31
10min1513297-51329793.71195.661.3493.8795.821.34
2521512-52151295.21195.37
3532685-53268597.25197.41
4524651-52465195.78495.94
5530342-53034296.82396.98
6521263-52126395.16595.32
15min1514637-51463793.95695.491.2294.2795.801.22
2518885-51888594.73195.05
3531198-53119896.97997.30
4524500-52450095.75696.07
5529082-52908296.59396.91
6519904-51990494.91795.23
20min1518436-51843694.64995.510.9795.1295.980.97
2518702-51870294.69895.17
3529865-52986596.73697.22
4523542-52354295.58196.06
5528582-52858296.50196.98
6519715-51971594.88395.36
30min1513496-51349693.74795.451.2794.3796.081.27
2518722-51872294.70195.33
3531535-53153597.04197.69
4524061-52406195.67696.31
5528537-52853796.49397.14
6520445-52044595.01695.65
45min1512948-51294893.64795.331.2394.4396.121.23
2518232-51823294.61295.40
3530065-53006596.77297.58
4523294-52329495.53696.33
5528213-52821396.43497.24
6520200-52020094.97195.76
极限1512426-51242693.55295.171.2094.4996.131.20
2517764-51776494.52695.47
3528994-52899496.57797.54
4522665-52266595.42196.38
5527204-52720496.25097.21
6518833-51883394.72295.67
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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250
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%
117.254788144785144775644779264775414780720.12
217.214781214786244783720.08
单位质量响应值RSD%判断
27714.3227796.170.21数据可信
供试品溶液-2022051701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%
5min1526252-52625296.00695.381.4896.0195.381.48
2521137-52113795.07395.07
3522018-52201895.23395.23
4508868-50886892.83492.83
5530061-53006196.70196.70
6528684-52868496.44996.45
10min1532955-53295597.22996.681.9297.3996.841.92
2523411-52341195.48795.65
3530224-53022496.73096.89
4513645-51364593.70693.86
5538141-53814198.17598.34
6541462-54146298.78198.94
15min1531277-53127796.92296.521.7797.2496.841.77
2522743-52274395.36695.68
3529087-52908796.52396.84
4514505-51450593.86394.17
5536803-53680397.93198.26
6539983-53998398.51198.84
20min1531639-53163996.98896.351.8197.4796.831.81
2520927-52092795.03495.51
3528556-52855696.42696.91
4513198-51319893.62494.09
5536803-53680397.93198.42
6537609-53760998.07898.57
30min1531299-53129996.92696.171.7297.5796.811.72
2520235-52023594.90895.54
3526804-52680496.10696.75
4513298-51329893.64294.27
5533635-53363597.35398.00
6537627-53762798.08198.73
45min1528859-52885996.48195.951.8397.2996.751.83
2517411-51741194.39395.19
3526681-52668196.08496.89
4511903-51190393.38894.17
5533726-53372697.36998.18
6537030-53703097.97298.79
极限1528354-52835496.38996.571.2897.3697.541.27
2518779-51877994.64295.59
3525493-52549395.86796.83
4536278-53627897.83598.77
5531022-53102296.87697.85
6536247-53624797.82998.81
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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250
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%
117.254771144779264780024779004781734778230.09
217.214773554769344771440.07
单位质量响应值RSD%判断
27699.8827724.810.07数据可信
供试品溶液-ER3500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%
5min1510007-51000793.18697.582.6393.1997.582.63
2536508-53650898.02898.03
3539066-53906698.49598.50
4537238-53723898.16198.16
5552447-552447100.940100.94
6529123-52912396.67996.68
10min1515088-51508894.11498.352.7294.2798.512.72
2537822-53782298.26898.43
3540672-54067298.78998.95
4540545-54054598.76698.93
5560827-560827102.472102.64
6534597-53459797.67997.84
15min1514166-51416693.94698.272.6694.2698.592.66
2539816-53981698.63298.96
3541676-54167698.97299.30
4540023-54002398.67099.00
5558221-558221101.995102.33
6533017-53301797.39097.71
20min1513865-51386593.89198.112.5694.3698.602.56
2537762-53776298.25798.75
3541129-54112998.87299.37
4540204-54020498.70399.20
5556037-556037101.596102.11
6532835-53283597.35797.84
30min1513271-51327193.78298.112.7794.4198.762.77
2538888-53888898.46399.12
3542060-54206099.04299.70
4540059-54005998.67799.33
5558060-558060101.966102.64
6529386-52938696.72797.38
45min1511844-51184493.52297.942.7094.3098.762.70
2538383-53838398.37199.19
3540292-54029298.71999.54
4537158-53715898.14798.97
5556405-556405101.664102.51
6532207-53220797.24298.05
极限1504125-50412592.11197.593.0893.0598.573.07
2538192-53819298.33699.32
3539372-53937298.55199.54
4538376-53837698.36999.35
5553487-553487101.130102.15
6531181-53118197.05598.03
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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250
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%
117.254781554787254780234784814781234783010.07
217.214778004771144774570.11
单位质量响应值RSD%判断
27727.5927743.000.04数据可信
供试品溶液-FA2516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%
5min1536244-53624497.89996.952.0197.9096.952.01
2537759-53775998.17598.18
3522500-52250095.39095.39
4521515-52151595.21095.21
5521517-52151795.21095.21
6546626-54662699.79499.79
10min1540220-54022098.62597.821.9498.7997.981.94
2541109-54110998.78798.95
3527637-52763796.32796.49
4526784-52678496.17296.33
5527109-52710996.23196.39
6552061-552061100.786100.95
15min1539980-53998098.58197.661.8598.9197.981.85
2538916-53891698.38798.71
3527178-52717896.24496.56
4526079-52607996.04396.36
5526979-52697996.20796.53
6550480-550480100.498100.83
20min1538902-53890298.38497.551.7698.8898.041.76
2539323-53932398.46198.95
3527042-52704296.21996.70
4525534-52553495.94396.42
5526584-52658496.13596.61
6548597-548597100.154100.66
30min1536768-53676897.99497.421.8898.6598.071.88
2538047-53804798.22898.88
3527156-52715696.24096.88
4523919-52391995.64996.29
5525798-52579895.99296.63
6550123-550123100.433101.10
45min1538979-53897998.39897.391.8199.2298.201.81
2538297-53829798.27499.09
3526232-52623296.07196.87
4523664-52366495.60296.40
5525773-52577395.98796.79
6547686-54768699.988100.82
极限1537104-53710498.05697.031.8699.0498.011.86
2536421-53642197.93198.91
3523726-52372695.61396.57
4522222-52222295.33996.30
5523260-52326095.52896.49
6546262-54626299.728100.73
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