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%
117.279560449553759552149554539550469554260.04
217.239528039534589531300.05
单位质量响应值RSD%判断
55322.8755318.050.01数据可信
供试品溶液-2024051911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%
5min11070500-107050097.98298.341.3197.9898.341.31
21056707-105670796.72096.72
31087289-108728999.51999.52
41070571-107057197.98997.99
51066599-106659997.62597.63
61094590-1094590100.187100.19
10min11104355-1104355101.081101.031.37101.24101.191.37
21125092-1125092102.979103.14
31104334-1104334101.079101.25
41089412-108941299.71399.88
51084748-108474899.28799.45
61114538-1114538102.013102.18
15min11104156-1104156101.063100.971.39101.39101.301.39
21125777-1125777103.042103.37
31103621-1103621101.014101.35
41089315-108931599.705100.03
51083560-108356099.17899.51
61112226-1112226101.802102.14
20min11101805-1101805100.848100.811.41101.35101.311.40
21123218-1123218102.808103.31
31100651-1100651100.742101.24
41088641-108864199.643100.14
51080886-108088698.93399.43
61112905-1112905101.864102.37
30min11098043-1098043100.503100.641.45101.17101.311.45
21123300-1123300102.815103.49
31098980-1098980100.589101.26
41086272-108627299.426100.09
51079716-107971698.82699.48
61110962-1110962101.686102.36
45min11095797-1095797100.298100.401.41101.13101.241.41
21119457-1119457102.463103.31
31096264-1096264100.341101.18
41083496-108349699.172100.00
51077767-107776798.64899.47
61108667-1108667101.476102.32
极限11094800-1094800100.20799.393.19101.21100.393.17
21115953-1115953102.143103.16
31094945-1094945100.220101.23
41081437-108143798.98499.98
51019745-101974593.33794.32
61108350-1108350101.447102.46
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%
117.279527429517139521269520719519889521280.04
217.239503089501169502120.02
单位质量响应值RSD%判断
55131.9155148.690.03数据可信
供试品溶液-2024051911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%
5min11075297-107529798.74399.071.6598.7499.071.65
21092447-1092447100.318100.32
31054289-105428996.81496.81
41062992-106299297.61397.61
51099250-1099250100.943100.94
61088807-108880799.98499.98
10min11090167-1090167100.109100.701.59100.27100.871.59
21104951-1104951101.466101.63
31073533-107353398.58198.74
41082513-108251399.40699.57
51118971-1118971102.754102.92
61109829-1109829101.914102.08
15min11087856-108785699.896100.661.71100.23100.991.71
21103331-1103331101.317101.65
31072288-107228898.46798.79
41081813-108181399.34199.67
51122282-1122282103.058103.40
61109384-1109384101.873102.21
20min11088625-108862599.967100.521.58100.46101.021.58
21102413-1102413101.233101.74
31071721-107172198.41598.90
41080316-108031699.20499.70
51116869-1116869102.561103.07
61107661-1107661101.715102.22
30min11086589-108658999.780100.371.54100.44101.031.54
21099215-1099215100.939101.61
31071325-107132598.37899.03
41079334-107933499.11499.77
51115447-1115447102.430103.11
61105887-1105887101.552102.23
45min11084230-108423099.563100.041.77100.39100.881.77
21097636-1097636100.794101.64
31060498-106049897.38498.20
41077663-107766398.96099.78
51113647-1113647102.265103.12
61103048-1103048101.291102.14
极限11082097-108209799.36899.911.54100.36100.911.54
21094356-1094356100.493101.50
31065416-106541697.83698.82
41074995-107499598.71599.70
51109789-1109789101.910102.93
61101145-1101145101.117102.13
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%
117.279499699502339499529503689499559500950.03
217.239483149485299484220.02
单位质量响应值RSD%判断
55014.1955044.810.04数据可信
供试品溶液-2024052011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%
5min11062222-106222297.73998.931.9997.7498.931.99
21096729-1096729100.914100.91
31091510-1091510100.434100.43
41081090-108109099.47599.47
51038994-103899495.60295.60
61080748-108074899.44399.44
10min11083535-108353599.700100.581.8999.86100.751.89
21108649-1108649102.011102.18
31117996-1117996102.871103.04
41104894-1104894101.665101.83
51079695-107969599.34799.51
61063928-106392897.89698.06
15min11083311-108331199.679101.211.24100.01101.541.24
21111073-1111073102.234102.57
31117922-1117922102.864103.20
41104173-1104173101.599101.93
51086997-1086997100.018100.34
61095998-1095998100.847101.18
20min11080821-108082199.450101.131.2599.95101.641.25
21105990-1105990101.766102.27
31117070-1117070102.786103.30
41102241-1102241101.421101.93
51084837-108483799.820100.31
61103813-1103813101.566102.06
30min11078199-107819999.209100.831.2799.87101.501.27
21105687-1105687101.738102.42
31114711-1114711102.569103.25
41100082-1100082101.222101.90
51082646-108264699.618100.28
61093827-1093827100.647101.31
45min11074682-107468298.885100.641.2699.71101.471.26
21103189-1103189101.508102.36
31111844-1111844102.305103.16
41098752-1098752101.100101.94
51082668-108266899.620100.44
61091082-1091082100.394101.23
极限11073535-107353598.780100.361.2799.77101.361.27
21098790-1098790101.104102.12
31110268-1110268102.160103.18
41095339-1095339100.786101.80
51077247-107724799.121100.11
61088882-1088882100.192101.19
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%
117.279511799514439503659513529514899511660.05
217.239522729522939522820.01
单位质量响应值RSD%判断
55076.2055268.830.25数据可信
供试品溶液-2024052011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%
5min11082502-108250299.34790.627.2699.3590.627.26
21063761-106376197.62797.63
3959283-95928388.03988.04
4932459-93245985.57785.58
5982053-98205390.12890.13
6904109-90410982.97582.97
10min11093504-1093504100.357100.081.43100.52100.231.43
21090418-1090418100.073100.24
31062589-106258997.51997.67
41094524-1094524100.450100.59
51110602-1110602101.926102.08
61091074-1091074100.134100.27
15min11094266-1094266100.427100.571.33100.76100.891.33
21090156-1090156100.049100.38
31073845-107384598.55298.86
41099651-1099651100.921101.23
51118485-1118485102.649102.97
61098845-1098845100.847101.15
20min11091598-1091598100.182100.431.26100.68100.921.26
21089966-1089966100.032100.53
31074032-107403298.57099.04
41097396-1097396100.714101.19
51116463-1116463102.464102.95
61096612-1096612100.642101.12
30min11090356-1090356100.068100.601.03100.73101.261.03
21096550-1096550100.636101.30
31081026-108102699.21299.85
41096580-1096580100.639101.29
51115283-1115283102.355103.02
61097386-1097386100.713101.35
45min11088996-108899699.943100.251.53100.78101.071.52
21085259-108525999.600100.43
31066745-106674597.90198.70
41092506-1092506100.265101.08
51113942-1113942102.232103.06
61106388-1106388101.539102.35
极限11086496-108649699.71499.791.40100.71100.781.39
21080616-108061699.174100.17
31064908-106490897.73298.70
41089082-108908299.951100.93
51111328-1111328101.992103.00
61091488-1091488100.172101.15
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