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125
标示量(mg)100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%
117.279458369459469465289434299436469450770.16
217.239451039431779441400.15
单位质量响应值RSD%判断
54723.6254796.290.10数据可信
供试品溶液-2024051911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%
5min11005885-100588593.01193.141.8093.0193.141.80
21032635-103263595.48495.48
31001348-100134892.59192.59
4992264-99226491.75191.75
51024669-102466994.74894.75
6986575-98657591.22591.23
10min11058029-105802997.83298.150.9497.9998.310.94
21067316-106731698.69198.85
31056516-105651697.69297.85
41066954-106695498.65898.81
51074004-107400499.30999.47
61046069-104606996.72696.88
15min11067922-106792298.74799.690.9399.07100.010.93
21082747-1082747100.118100.44
31082063-1082063100.055100.37
41082662-1082662100.110100.43
51089596-1089596100.751101.07
61063920-106392098.37798.69
20min11077091-107709199.595100.190.75100.08100.680.75
21084381-1084381100.269100.76
31084670-1084670100.296100.78
41088555-1088555100.655101.14
51094772-1094772101.230101.72
61071933-107193399.11899.60
30min11081920-1081920100.041100.600.47100.69101.250.47
21089532-1089532100.745101.40
31088346-1088346100.636101.29
41091391-1091391100.917101.57
51094364-1094364101.192101.85
61082110-1082110100.059100.70
45min11083628-1083628100.199100.490.30101.01101.310.30
21088192-1088192100.621101.45
31085622-1085622100.384101.20
41086834-1086834100.496101.32
51092267-1092267100.998101.83
61084191-1084191100.251101.06
极限11084073-1084073100.240100.310.27101.22101.300.28
21086765-1086765100.489101.48
31082587-1082587100.103101.09
41084998-1084998100.326101.31
51089441-1089441100.737101.73
61081392-108139299.993100.97
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125
标示量(mg)100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%
117.279423589424839416269418919420009420720.04
217.239398929415569407240.13
单位质量响应值RSD%判断
54549.6254598.030.07数据可信
供试品溶液-2024051911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%
5min1955226-95522688.62891.803.4088.6391.803.40
2995136-99513692.33192.33
3943002-94300287.49387.49
41002882-100288293.04993.05
51030385-103038595.60195.60
61009790-100979093.69093.69
10min11063005-106300598.62898.391.1298.7898.551.12
21045164-104516496.97297.13
31052046-105204697.61197.76
41075677-107567799.80399.96
51071826-107182699.44699.61
61054937-105493797.87998.04
15min11075243-107524399.76399.321.06100.0899.641.06
21052552-105255297.65897.97
31065828-106582898.89099.20
41076997-107699799.926100.25
51085140-1085140100.681101.01
61067103-106710399.00899.33
20min11081687-1081687100.36199.741.11100.84100.231.11
21054803-105480397.86798.34
31071812-107181299.44599.92
41082837-1082837100.468100.96
51087995-1087995100.946101.44
61071056-107105699.37599.86
30min11080483-1080483100.249100.011.09100.89100.661.08
21060712-106071298.41599.06
31071940-107194099.457100.10
41086720-1086720100.828101.48
51093654-1093654101.471102.13
61073906-107390699.639100.29
45min11080717-1080717100.27199.740.94101.08100.560.95
21060381-106038198.38499.19
31070153-107015399.291100.10
41081069-1081069100.304101.13
51088212-1088212100.966101.80
61069674-106967499.246100.06
极限11079384-1079384100.14799.611.08101.13100.591.08
21063494-106349498.67399.64
31061191-106119198.45999.43
41081283-1081283100.323101.31
51089822-1089822101.116102.11
61066385-106638598.94199.92
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125
标示量(mg)100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%
117.279488559487879469359462119488019479180.14
217.239432769435709434230.03
单位质量响应值RSD%判断
54888.1354754.670.18数据可信
供试品溶液-2024052011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%
5min11007960-100796093.09892.211.5393.1092.211.54
2981378-98137890.64390.64
3997327-99732792.11692.12
4983659-98365990.85490.85
51022133-102213394.40794.41
6997511-99751192.13392.13
10min11058588-105858897.77497.721.1597.9397.871.15
21044992-104499296.51996.67
31058699-105869997.78597.94
41043381-104338196.37096.52
51071172-107117298.93799.09
61071146-107114698.93499.09
15min11077286-107728699.50198.941.9199.8299.251.91
21064560-106456098.32698.64
31077312-107731299.50499.82
41033224-103322495.43295.74
51085963-1085963100.303100.63
61088635-1088635100.550100.87
20min11089670-1089670100.645100.331.52101.13100.811.52
21068056-106805698.64999.12
31106508-1106508102.200102.68
41064617-106461798.33198.80
51094348-1094348101.077101.57
61094153-1094153101.059101.55
30min11098616-1098616101.471100.441.00102.12101.091.00
21074885-107488599.28099.92
31094784-1094784101.118101.77
41072834-107283499.09099.73
51091608-1091608100.824101.48
61092257-1092257100.884101.54
45min11095843-1095843101.215100.311.03102.04101.131.03
21075038-107503899.294100.10
31089345-1089345100.615101.44
41069430-106943098.77699.58
51091411-1091411100.806101.63
61095365-1095365101.171101.99
极限11096753-1096753101.299100.051.12102.29101.041.12
21072281-107228199.039100.01
31086081-1086081100.314101.30
41064893-106489398.35799.32
51089140-1089140100.596101.59
61090315-1090315100.705101.70
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125
标示量(mg)100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%
117.279469569446789445749432919439659446930.15
217.239460489458639459560.02
单位质量响应值RSD%判断
54701.3954901.680.26数据可信
供试品溶液-2024052011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%
5min1939997-93999786.85386.6611.5586.8586.6611.54
2751962-75196269.47969.48
3876517-87651780.98780.99
41022669-102266994.49194.49
51027975-102797594.98194.98
61008178-100817893.15293.15
10min11068961-106896198.76897.851.1798.9198.001.19
21041279-104127996.21196.33
31045911-104591196.63996.77
41066911-106691198.57998.74
51069636-106963698.83198.99
61061409-106140998.07198.23
15min11088275-1088275100.55399.550.97100.8699.860.98
21063260-106326098.24298.52
31065988-106598898.49498.79
41078941-107894199.691100.01
51085441-1085441100.291100.61
61082589-1082589100.028100.35
20min11094476-1094476101.126100.230.93101.60100.700.94
21069885-106988598.85499.29
31075508-107550899.37399.83
41088500-1088500100.574101.06
51093773-1093773101.061101.55
61086749-1086749100.412100.90
30min11091328-1091328100.835100.460.89101.48101.100.91
21071775-107177599.02899.63
31078623-107862399.661100.29
41092894-1092894100.980101.64
51094750-1094750101.151101.81
61093990-1093990101.081101.73
45min11091101-1091101100.814100.120.82101.63100.930.83
21072168-107216899.06599.83
31072935-107293599.13699.93
41085491-1085491100.296101.12
51090552-1090552100.763101.59
61089356-1089356100.653101.47
极限11089932-1089932100.706100.210.68101.69101.180.70
21073148-107314899.155100.09
31078087-107808799.612100.57
41085519-1085519100.298101.29
51090834-1090834100.789101.78
61089735-1089735100.688101.68
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