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%
117.064624504625174625614629064625614625990.04
216.984623234621544622380.03
单位质量响应值RSD%判断
27116.0027222.500.28数据可信
供试品溶液-2024041511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%
5min1555849-555849103.592102.002.46103.59102.002.46
2562966-562966104.919104.92
3528298-52829898.45898.46
4540021-540021100.643100.64
5557572-557572103.914103.91
6539194-539194100.489100.49
10min1538339-538339100.329101.301.21100.50101.471.21
2545955-545955101.749101.92
3533908-53390899.50399.67
4545483-545483101.661101.83
5552763-552763103.017103.19
6544770-544770101.528101.70
15min1537602-537602100.192101.321.23100.53101.661.23
2545445-545445101.654102.00
3533876-53387699.49799.83
4544631-544631101.502101.84
5550684-550684102.630102.97
6549629-549629102.433102.77
20min1536273-53627399.944101.021.13100.45101.521.13
2543549-543549101.300101.81
3533744-53374499.47399.97
4544001-544001101.384101.89
5550664-550664102.626103.14
6543912-543912101.368101.88
30min1535141-53514199.733100.831.27100.41101.511.27
2543217-543217101.238101.92
3530904-53090498.94499.61
4542573-542573101.118101.79
5549909-549909102.485103.17
6544436-544436101.465102.14
45min1533550-53355099.437100.920.94100.28101.770.94
2541198-541198100.862101.71
3541458-541458100.910101.74
4541273-541273100.876101.72
5549610-549610102.430103.29
6542017-542017101.015101.86
极限1532938-53293899.323100.521.18100.33101.531.18
2541167-541167100.856101.88
3531482-53148299.051100.05
4539946-539946100.629101.64
5548796-548796102.278103.31
6541745-541745100.964101.98
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%
117.064608314613174604204609044611044609150.08
216.984623754623334623540.01
单位质量响应值RSD%判断
27017.2927229.330.56数据可信
供试品溶液-2024041511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%
5min1527672-52767298.50998.191.4898.5198.191.48
2523082-52308297.65297.65
3518329-51832996.76596.76
4536222-536222100.105100.11
5533065-53306599.51699.52
6517330-51733096.57896.58
10min1533064-53306499.51599.831.2999.6899.991.29
2531744-53174499.26999.43
3535178-53517899.910100.07
4543700-543700101.501101.67
5540527-540527100.909101.07
6524212-52421297.86398.02
15min1533157-53315799.53399.641.6099.8699.971.60
2531919-53191999.30299.63
3526538-52653898.29798.62
4546533-546533102.030102.37
5540335-540335100.873101.21
6523833-52383397.79298.12
20min1531346-53134699.19599.531.6399.69100.031.63
2530336-53033699.00699.50
3526340-52634098.26098.75
4547618-547618102.233102.74
5538949-538949100.614101.12
6524382-52438297.89598.38
30min1531794-53179499.27899.811.4299.94100.481.42
2532178-53217899.350100.01
3534396-53439699.764100.42
4546712-546712102.063102.74
5538708-538708100.569101.24
6524181-52418197.85798.51
45min1531157-53115799.15999.531.4999.99100.361.49
2531622-53162299.246100.07
3525787-52578798.15798.98
4545900-545900101.912102.76
5538711-538711100.570101.41
6525533-52553398.11098.92
极限1539027-539027100.62999.551.62101.62100.541.62
2529714-52971498.89099.88
3525265-52526598.06099.04
4545262-545262101.793102.81
5537021-537021100.254101.26
6523097-52309797.65598.63
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%
117.064621504627414631054629924623134626600.10
216.984630444625744628090.08
单位质量响应值RSD%判断
27119.5827256.120.36数据可信
供试品溶液-2024051711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%
5min1518521-51852196.57096.490.8596.5796.490.85
2512005-51200595.35695.36
3522559-52255997.32297.32
4523477-52347797.49397.49
5515296-51529695.96995.97
6516687-51668796.22896.23
10min1525205-52520597.81598.551.2097.9898.711.20
2523574-52357497.51197.67
3536328-53632899.886100.05
4537149-537149100.039100.20
5523110-52311097.42597.58
6529542-52954298.62298.78
15min1526488-52648898.05498.631.1698.3898.961.16
2523841-52384197.56197.88
3536078-53607899.840100.17
4537349-537349100.076100.41
5523274-52327497.45597.78
6530390-53039098.78099.11
20min1527450-52745098.23398.761.3398.7299.251.33
2525372-52537297.84698.33
3536070-53607099.838100.33
4541659-541659100.879101.38
5523796-52379697.55298.04
6527210-52721098.18898.68
30min1528492-52849298.42799.301.0399.0899.951.03
2531658-53165899.01799.66
3535869-53586999.801100.46
4537871-537871100.174100.84
5525667-52566797.90198.55
6539500-539500100.477101.13
45min1527986-52798698.33398.910.9399.1599.730.93
2533754-53375499.407100.22
3534674-53467499.578100.41
4537000-537000100.011100.84
5523717-52371797.53898.35
6529410-52941098.59899.42
极限1527042-52704298.15798.921.0999.1499.901.08
2538975-538975100.379101.36
3533448-53344899.350100.34
4535288-53528899.693100.69
5523662-52366297.52798.50
6528317-52831798.39499.38
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%
117.064633744635814636674631534627534633060.08
216.984637544633584635560.07
单位质量响应值RSD%判断
27157.4427300.120.38数据可信
供试品溶液-2024051711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%
5min1526518-52651897.91297.310.8297.9197.310.82
2525105-52510597.64997.65
3522395-52239597.14597.15
4523420-52342097.33697.34
5515293-51529395.82495.82
6526872-52687297.97897.98
10min1534391-53439199.37699.951.0199.54100.111.01
2544645-544645101.283101.45
3537041-53704199.869100.03
4540060-540060100.430100.59
5528990-52899098.37298.53
6539771-539771100.376100.54
15min1535009-53500999.491100.061.0899.82100.391.07
2547111-547111101.741102.07
3538129-538129100.071100.40
4534715-53471599.43699.77
5531264-53126498.79499.12
6542309-542309100.848101.18
20min1537001-53700199.861100.341.31100.36100.831.31
2551644-551644102.584103.09
3538444-538444100.130100.62
4534615-53461599.41899.91
5532165-53216598.96299.45
6543447-543447101.060101.56
30min1537946-537946100.037100.140.99100.70100.800.98
2545741-545741101.487102.16
3537756-537756100.002100.66
4535090-53509099.506100.17
5531214-53121498.78599.44
6543108-543108100.997101.66
45min1536574-53657499.782100.161.19100.61100.991.18
2548661-548661102.030102.87
3536898-53689899.842100.67
4535738-53573899.626100.45
5530595-53059598.67099.49
6543271-543271101.027101.86
极限1535602-53560299.60199.710.98100.60100.710.98
2542882-542882100.955101.97
3535229-53522999.532100.53
4533636-53363699.236100.23
5528462-52846298.27399.26
6541199-541199100.642101.65
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