枸橼酸西地那非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号20230107对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.219949039842069846219853569852939868760.46
210.219838259836349837300.02
单位质量响应值RSD%判断
96657.7996349.660.23数据可信
供试品溶液-2022052001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%
5min11070258-1070258110.904111.561.42110.90111.561.42
21060276-1060276109.869109.87
31067739-1067739110.643110.64
41087785-1087785112.720112.72
51101637-1101637114.155114.16
61071870-1071870111.071111.07
10min11079772-1079772111.889113.591.03112.11113.821.03
21093117-1093117113.272113.49
31089826-1089826112.931113.15
41102729-1102729114.268114.49
51112041-1112041115.233115.46
61099900-1099900113.975114.20
15min11079293-1079293111.840114.051.08112.29114.501.08
21095938-1095938113.565114.01
31109507-1109507114.971115.42
41105158-1105158114.520114.97
51111733-1111733115.201115.66
61101849-1101849114.177114.63
20min11087530-1087530112.693113.590.75113.36114.270.75
21094639-1094639113.430114.10
31087731-1087731112.714113.39
41101907-1101907114.183114.87
51108294-1108294114.845115.53
61097234-1097234113.699114.38
30min11075052-1075052111.400113.281.02112.29114.181.02
21092679-1092679113.227114.13
31087881-1087881112.730113.63
41100317-1100317114.018114.93
51107600-1107600114.773115.69
61095503-1095503113.520114.43
45min11072414-1072414111.127113.020.98112.24114.150.98
21090426-1090426112.993114.12
31087174-1087174112.656113.78
41098319-1098319113.811114.95
51103232-1103232114.320115.47
61092467-1092467113.205114.34
极限11071814-1071814111.065112.831.09112.40114.191.09
21088571-1088571112.801114.15
31081360-1081360112.054113.41
41093021-1093021113.262114.63
51106984-1106984114.709116.09
61091612-1091612113.116114.48
枸橼酸西地那非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号20230107对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.219834619830009836049833609824899831830.05
210.219882399866099874240.12
单位质量响应值RSD%判断
96296.0896711.460.31数据可信
供试品溶液-2022052001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%
5min11070850-1070850110.965110.741.73110.97110.741.73
21088048-1088048112.747112.75
31035325-1035325107.284107.28
41074125-1074125111.304111.30
51062797-1062797110.131110.13
61080646-1080646111.980111.98
10min11080231-1080231111.937112.230.97112.16112.450.97
21096894-1096894113.664113.89
31074282-1074282111.321111.54
41084890-1084890112.420112.64
51069612-1069612110.837111.06
61092461-1092461113.204113.43
15min11082685-1082685112.191112.411.00112.64112.861.00
21096832-1096832113.657114.11
31078246-1078246111.731112.17
41087165-1087165112.656113.10
51068340-1068340110.705111.15
61095731-1095731113.543113.99
20min11081624-1081624112.082112.761.36112.75113.431.36
21098173-1098173113.796114.48
31109159-1109159114.935115.60
41084295-1084295112.358113.03
51066016-1066016110.464111.13
61089660-1089660112.914113.59
30min11083926-1083926112.320112.170.96113.21113.070.95
21093518-1093518113.314114.22
31074911-1074911111.386112.28
41084582-1084582112.388113.29
51066398-1066398110.504111.39
61091701-1091701113.126114.03
45min11074696-1074696111.364111.851.00112.48112.971.00
21092395-1092395113.198114.33
31072514-1072514111.138112.25
41080626-1080626111.978113.10
51064997-1064997110.359111.46
61090970-1090970113.050114.18
极限11075342-1075342111.431111.830.72112.77113.180.72
21090009-1090009112.950114.31
31068854-1068854110.758112.09
41077586-1077586111.663113.01
51077169-1077169111.620112.95
61086419-1086419112.578113.93
枸橼酸西地那非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号20230107对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.219814809811629823999835209806689818460.12
210.219833629835319834460.02
单位质量响应值RSD%判断
96165.1396321.840.12数据可信
供试品溶液-EW4378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%
5min11064894-1064894110.646104.767.54110.65104.767.54
2860123-86012389.37089.37
31040205-1040205108.081108.08
41036636-1036636107.710107.71
51049989-1049989109.097109.10
6997630-997630103.657103.66
10min11077999-1077999112.008112.361.39112.23112.561.38
21104946-1104946114.807114.99
31089358-1089358113.188113.40
41076152-1076152111.816112.03
51059866-1059866110.123110.34
61079740-1079740112.188112.40
15min11078594-1078594112.069112.571.39112.51113.001.38
21102035-1102035114.505114.91
31096533-1096533113.933114.38
41082672-1082672112.493112.93
51059319-1059319110.067110.51
61081228-1081228112.343112.77
20min11076466-1076466111.848112.641.54112.52113.301.52
21103616-1103616114.669115.31
31103799-1103799114.688115.36
41078442-1078442112.054112.72
51061652-1061652110.309110.97
61080427-1080427112.260112.92
30min11076263-1076263111.827112.421.93112.72113.301.91
21109386-1109386115.269116.14
31101459-1101459114.445115.34
41076181-1076181111.819112.71
51051344-1051344109.238110.12
61077072-1077072111.911112.79
45min11071261-1071261111.307112.001.47112.42113.111.46
21096447-1096447113.924115.02
31095331-1095331113.808114.94
41075525-1075525111.750112.86
51054559-1054559109.572110.67
61074541-1074541111.648112.75
极限11069093-1069093111.082111.691.30112.42113.021.29
21093022-1093022113.568114.89
31090219-1090219113.277114.63
41069147-1069147111.088112.42
51056631-1056631109.787111.10
61071776-1071776111.361112.69
枸橼酸西地那非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号20230107对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.219816899855259823129814049820169825890.18
210.219808949824119816520.11
单位质量响应值RSD%判断
96237.9096146.130.07数据可信
供试品溶液-EW4378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%
5min11034412-1034412107.536106.393.81107.54106.393.81
21034232-1034232107.517107.52
3955022-95502299.28399.28
41069982-1069982111.234111.23
51038944-1038944108.007108.01
61007513-1007513104.740104.74
10min11055514-1055514109.730111.382.02109.94111.592.02
21052627-1052627109.430109.64
31086491-1086491112.950113.15
41087545-1087545113.060113.28
51097827-1097827114.129114.34
61048089-1048089108.958109.17
15min11055653-1055653109.744111.522.03110.18111.962.03
21049668-1049668109.122109.56
31091032-1091032113.422113.85
41086169-1086169112.917113.37
51099147-1099147114.266114.71
61054761-1054761109.652110.08
20min11049938-1049938109.150111.372.15109.80112.022.15
21051339-1051339109.296109.95
31090274-1090274113.344113.99
41087920-1087920113.099113.77
51097905-1097905114.137114.81
61050253-1050253109.183109.83
30min11052399-1052399109.406111.421.99110.28112.301.99
21053617-1053617109.533110.40
31087434-1087434113.048113.93
41087072-1087072113.011113.91
51097909-1097909114.137115.04
61051926-1051926109.357110.22
45min11052007-1052007109.365111.342.04110.46112.442.04
21054464-1054464109.621110.71
31090407-1090407113.357114.46
41084239-1084239112.716113.84
51096792-1096792114.021115.15
61048053-1048053108.954110.04
极限11050885-1050885109.249110.901.99110.56112.231.99
21048607-1048607109.012110.32
31080129-1080129112.289113.62
41079082-1079082112.180113.53
51096434-1096434113.984115.34
61045454-1045454108.684109.99
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