军原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500
标示量(mg)25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%
117.312334642347562342282340682344682341970.21
217.322327692339382333540.36
单位质量响应值RSD%判断
13529.5813473.090.30数据可信
影响因素30天-供试品溶液-2024051611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%
5min1268891-268891100.84499.840.94100.8499.840.94
2265518-26551899.57999.58
3264308-26430899.12599.12
4263369-26336998.77398.77
5269538-269538101.086101.09
6265699-26569999.64799.65
10min1270762-270762101.545100.960.89101.71101.130.89
2269319-269319101.004101.17
3266804-266804100.061100.23
4266619-26661999.992100.16
5272850-272850102.328102.50
6268889-268889100.843101.01
15min1269593-269593101.107101.000.50101.44101.330.50
2269393-269393101.032101.37
3268073-268073100.537100.87
4267436-267436100.298100.63
5270661-270661101.508101.85
6270660-270660101.507101.84
20min1272330-272330102.133100.910.84102.64101.420.84
2269052-269052100.904101.41
3266020-26602099.767100.27
4267339-267339100.262100.76
5270670-270670101.511102.02
6268997-268997100.883101.39
30min1268052-268052100.529101.421.66101.21102.091.65
2268338-268338100.636101.31
3279205-279205104.712105.38
4266797-266797100.058100.72
5270091-270091101.294101.97
6270022-270022101.268101.94
45min1267470-267470100.311100.591.10101.15101.431.09
2267583-267583100.353101.19
3266021-26602199.767100.61
4265296-26529699.495100.33
5269428-269428101.045101.89
6273461-273461102.558103.40
极限1268752-268752100.792100.350.44101.80101.360.44
2267574-267574100.350101.36
3266411-26641199.914100.92
4266004-26600499.761100.76
5267937-267937100.486101.50
6268787-268787100.805101.82
军原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500
标示量(mg)25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%
117.312324652341602339922340132338642336990.30
217.322381882383362382620.05
单位质量响应值RSD%判断
13500.8113756.471.33数据可信
影响因素30天-供试品溶液-2024051611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%
5min1261334-26133497.10297.821.5097.1097.821.50
2259643-25964396.47496.47
3264632-26463298.32898.33
4260593-26059396.82796.83
5262861-26286197.67097.67
6270453-270453100.490100.49
10min1271289-271289100.80199.631.69100.9699.791.69
2261040-26104096.99397.15
3269682-269682100.204100.37
4264098-26409898.12998.29
5270370-270370100.460100.62
6272356-272356101.198101.37
15min1264235-26423598.18098.961.6698.5199.281.66
2260446-26044696.77297.09
3269404-269404100.101100.43
4262806-26280697.64997.97
5269861-269861100.271100.60
6271224-271224100.777101.11
20min1263950-26395098.07498.921.7798.5799.421.77
2259674-25967496.48596.97
3268335-26833599.704100.20
4263308-26330897.83698.32
5269833-269833100.260100.76
6272275-272275101.167101.67
30min1263093-26309397.75699.282.0498.4199.942.04
2259068-25906896.26096.90
3268412-26841299.732100.40
4268761-26876199.862100.51
5268997-26899799.949100.61
6274841-274841102.121102.79
45min1260712-26071296.87198.401.9597.6999.221.95
2258139-25813995.91596.72
3267491-26749199.390100.22
4262529-26252997.54698.36
5268653-26865399.822100.65
6271461-271461100.865101.71
极限1263140-26314097.77399.523.2998.75100.503.28
2258663-25866396.11097.07
3283460-283460105.323106.32
4262390-26239097.49598.47
5268830-26883099.887100.88
6270531-270531100.519101.53
军原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500
标示量(mg)25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%
117.312356842350932348862347332341082349010.25
217.322327452337232332340.30
单位质量响应值RSD%判断
13570.2513466.170.55数据可信
影响因素30天-供试品溶液-2024051611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%
5min1267576-267576100.22699.901.10100.2399.901.10
2268399-268399100.535100.53
3260795-26079597.68697.69
4268233-268233100.472100.47
5267169-267169100.074100.07
6268010-268010100.389100.39
10min1269002-269002100.760100.561.09100.93100.721.09
2269781-269781101.052101.22
3263277-26327798.61698.78
4267007-267007100.013100.18
5270855-270855101.455101.62
6270822-270822101.442101.61
15min1270204-270204101.211100.681.14101.55101.021.14
2271387-271387101.654101.99
3263028-26302898.52398.85
4267764-267764100.297100.63
5270278-270278101.238101.57
6270080-270080101.164101.50
20min1269633-269633100.997100.620.90101.50101.120.90
2269819-269819101.067101.57
3263997-26399798.88699.38
4268071-268071100.412100.91
5270269-270269101.235101.74
6269947-269947101.114101.62
30min1269348-269348100.890100.491.18101.56101.161.18
2271654-271654101.754102.43
3262606-26260698.36599.02
4267059-267059100.033100.70
5269862-269862101.083101.76
6269157-269157100.819101.49
45min1273611-273611102.487100.211.57103.33101.051.56
2268179-268179100.452101.30
3260765-26076597.67598.50
4266456-26645699.807100.64
5267066-267066100.035100.88
6269185-269185100.829101.67
极限1266692-26669299.89599.840.96100.91100.840.96
2267279-267279100.115101.13
3261684-26168498.01999.00
4266483-26648399.817100.82
5268481-268481100.565101.57
6268579-268579100.602101.61
军原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500
标示量(mg)25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%
117.314666714688204687744686524686564683150.20
217.324662624683954673280.33
单位质量响应值RSD%判断
27054.5926981.990.20数据可信
影响因素30天-供试品溶液-2024051711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%
5min1542302-542302101.63298.831.61101.6398.831.61
2525874-52587498.55498.55
3530452-53045299.41199.41
4517297-51729796.94696.95
5524167-52416798.23498.23
6523926-52392698.18898.19
10min1547083-547083102.528100.221.38102.70100.391.38
2534423-534423100.156100.32
3537016-537016100.642100.81
4524452-52445298.28798.45
5533204-53320499.927100.09
6532462-53246299.78899.95
15min1543266-543266101.813100.141.18102.15100.471.18
2535211-535211100.303100.63
3536333-536333100.514100.85
4524194-52419498.23998.56
5535446-535446100.347100.68
6531438-53143899.59699.93
20min1541505-541505101.48399.901.23101.99100.401.23
2534474-534474100.165100.66
3535731-535731100.401100.90
4522268-52226897.87898.37
5534779-534779100.222100.72
6529487-52948799.23199.73
30min1543256-543256101.81199.981.35102.49100.651.35
2533699-533699100.020100.69
3536601-536601100.564101.23
4521679-52167997.76798.42
5535373-535373100.334101.00
6530462-53046299.413100.07
45min1545494-545494102.23099.961.43103.08100.801.43
2532742-53274299.841100.67
3534572-534572100.184101.02
4522316-52231697.88798.70
5535416-535416100.342101.17
6529855-52985599.300100.13
极限1536500-536500100.545100.160.44101.56101.160.43
2531731-53173199.651100.65
3535223-535223100.306101.31
4535715-535715100.398101.38
5536154-536154100.480101.48
6531314-53131499.573100.57
军原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500
标示量(mg)25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%
117.314717974712054713324716354716344715210.06
217.324662284698524680400.55
单位质量响应值RSD%判断
27239.8027023.090.57数据可信
影响因素30天-供试品溶液-2024051711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%
5min1514603-51460396.04097.021.1496.0497.021.14
2528573-52857398.64898.65
3518022-51802296.67896.68
4514549-51454996.03096.03
5525738-52573898.11898.12
6517648-51764896.60996.61
10min1512296-51229695.61098.682.0595.7798.842.05
2544434-544434101.608101.77
3527301-52730198.41098.57
4528188-52818898.57698.74
5535723-53572399.982100.15
6524552-52455297.89798.06
15min1520591-52059197.15898.240.9997.4898.570.99
2533439-53343999.55699.89
3523465-52346597.69498.02
4530694-53069499.04399.37
5528228-52822898.58398.91
6521939-52193997.40997.73
20min1519434-51943496.94298.471.3897.4298.961.38
2538712-538712100.540101.04
3523709-52370997.74098.23
4530005-53000598.91599.40
5532101-53210199.30699.80
6521900-52190097.40297.89
30min1517361-51736196.55598.621.4297.2099.271.42
2536504-536504100.128100.79
3527113-52711398.37599.03
4532382-53238299.358100.01
5534703-53470399.792100.45
6522421-52242197.49998.15
45min1518841-51884196.83198.551.2197.6499.371.21
2534039-53403999.668100.50
3523928-52392897.78198.60
4531505-53150599.195100.01
5534747-53474799.800100.63
6525142-52514298.00798.82
极限1518282-51828296.72798.821.4597.6999.811.45
2538861-538861100.568101.57
3524829-52482997.94998.93
4529939-52993998.90299.89
5536869-536869100.196101.19
6528291-52829198.59599.57
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