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%
117.579507419498289511689510919500789505810.07
217.529526869541049533950.11
单位质量响应值RSD%判断
54102.5054417.520.42数据可信
加速6月-供试品溶液-2024051911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%
5min1962914-96291489.85890.261.6989.8690.261.69
2959592-95959289.54889.55
3972681-97268190.77090.77
4990081-99008192.39492.39
5975684-97568491.05091.05
6942269-94226987.93287.93
10min11034866-103486696.57395.411.9096.7295.561.90
21008209-100820994.08594.23
31016047-101604794.81794.97
41042552-104255297.29097.44
51038923-103892396.95297.10
6994128-99412892.77192.92
15min11051882-105188298.16197.621.5398.4797.921.52
21030027-103002796.12196.43
31040810-104081097.12897.44
41061474-106147499.05699.37
51064843-106484399.37099.68
61027181-102718195.85696.16
20min11058168-105816898.74799.171.1699.2299.651.16
21043348-104334897.36497.83
31067452-106745299.614100.08
41074955-1074955100.314100.80
51075177-1075177100.335100.81
61057396-105739698.67599.14
30min11070153-107015399.866100.581.33100.50101.211.33
21055906-105590698.53699.16
31086053-1086053101.350101.99
41078998-1078998100.691101.34
51098262-1098262102.489103.14
61077207-1077207100.524101.15
45min11081159-1081159100.893100.920.84101.70101.730.84
21068213-106821399.685100.48
31082749-1082749101.041101.85
41080288-1080288100.812101.63
51096575-1096575102.332103.15
61079671-1079671100.754101.55
极限11083201-1083201101.083100.890.74102.06101.860.74
21069360-106936099.792100.75
31083301-1083301101.093102.07
41078838-1078838100.676101.66
51093625-1093625102.056103.04
61078265-1078265100.623101.58
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%
117.579530389516779524489519599496419517530.14
217.529522989525529524250.02
单位质量响应值RSD%判断
54169.2154362.160.26数据可信
加速6月-供试品溶液-2024052011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%
5min1984096-98409691.82589.111.8191.8389.111.81
2935673-93567387.30787.31
3954909-95490989.10289.10
4942285-94228587.92487.92
5963561-96356189.90989.91
6949496-94949688.59788.60
10min11040464-104046497.08596.170.7697.2496.320.75
21034910-103491096.56696.71
31017794-101779494.96995.12
41032736-103273696.36496.51
51026887-102688795.81895.97
61031448-103144896.24396.39
15min11052360-105236098.19598.280.7098.5198.590.70
21056633-105663398.59398.90
31040749-104074997.11197.42
41060060-106006098.91399.22
51050065-105006597.98198.29
61060088-106008898.91699.22
20min11061303-106130399.02999.240.7999.5199.710.78
21068052-106805299.659100.13
31051980-105198098.15998.63
41073848-1073848100.200100.67
51056777-105677798.60799.08
61069465-106946599.791100.26
30min11083019-1083019101.055100.521.05101.70101.161.04
21084866-1084866101.228101.86
31072471-1072471100.071100.70
41092120-1092120101.905102.54
51062054-106205499.09999.74
61069399-106939999.785100.42
45min11086327-1086327101.364100.981.31102.18101.791.30
21097539-1097539102.410103.22
31085521-1085521101.289102.09
41094045-1094045102.084102.89
51064837-106483799.359100.16
61065271-106527199.399100.20
极限11086490-1086490101.379100.841.27102.36101.821.26
21091696-1091696101.865102.84
31082176-1082176100.977101.94
41095736-1095736102.242103.22
51062955-106295599.183100.15
61065349-106534999.407100.38
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%
117.579497469490819491889479769495699491120.08
217.529498499504639501560.05
单位质量响应值RSD%判断
54018.9054232.650.28数据可信
加速6月-供试品溶液-2024052111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%
5min1922870-92287086.33589.263.0586.3389.263.05
2958672-95867289.68489.68
3928820-92882086.89186.89
41003130-100313093.84393.84
5965334-96533490.30790.31
6946017-94601788.50088.50
10min1979419-97941991.62594.982.6891.7795.132.68
21018366-101836695.26895.42
3988488-98848892.47392.62
41053069-105306998.51598.67
51024406-102440695.83395.98
61028253-102825396.19396.34
15min1997899-99789993.35496.822.3593.6597.132.35
21040347-104034797.32597.63
31018174-101817495.25095.55
41068358-106835899.945100.27
51038945-103894597.19497.50
61046117-104611797.86598.17
20min11021260-102126095.53998.481.7895.9998.951.78
21054606-105460698.65999.13
31041325-104132597.41697.87
41072304-1072304100.314100.80
51061241-106124199.27999.75
61065508-106550899.679100.15
30min11044049-104404997.67199.631.4198.28100.261.42
21071811-1071811100.268100.90
31052317-105231798.44599.06
41086074-1086074101.603102.26
51064683-106468399.601100.24
61070731-1070731100.167100.80
45min11060579-106057999.217100.371.2599.99101.171.26
21080285-1080285101.061101.86
31058706-105870699.04299.83
41093423-1093423102.290103.11
51066452-106645299.767100.57
61077837-1077837100.832101.64
极限11064927-106492799.624100.481.23100.56101.451.24
21086329-1086329101.626102.60
31060376-106037699.198100.15
41092268-1092268102.182103.18
51063563-106356399.497100.47
61077071-1077071100.760101.73
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