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%
117.901964241964921963381962551962481963510.06
217.711961941959451960700.09
单位质量响应值RSD%判断
10969.3311071.150.66数据可信
供试品溶液-2022072301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%
5min1215570-21557099.05098.630.9599.0598.630.95
2216213-21621399.34599.35
3212912-21291297.82997.83
4215535-21553599.03499.03
5216323-21632399.39699.40
6211360-21136097.11597.12
10min1218310-218310100.30999.561.09100.4799.721.09
2218053-218053100.191100.36
3215157-21515798.86099.02
4217044-21704499.72799.89
5218822-218822100.544100.71
6212659-21265997.71297.87
15min1217585-21758599.97699.221.14100.3199.551.14
2217904-217904100.122100.45
3213799-21379998.23698.56
4215667-21566799.09499.43
5218359-218359100.331100.66
6212369-21236997.57997.90
20min1216962-21696299.68999.660.77100.19100.160.76
2217315-21731599.852100.35
3213974-21397498.31798.81
4216335-21633599.40199.90
5218496-218496100.394100.89
6218322-218322100.314100.80
30min1216260-21626099.36799.632.10100.03100.292.09
2216997-21699799.706100.37
3213289-21328998.00298.66
4224939-224939103.355104.02
5217494-21749499.934100.60
6211955-21195597.38998.04
45min1215878-21587899.19198.850.95100.0299.680.95
2216723-21672399.580100.41
3214042-21404298.34899.17
4215422-21542298.98299.82
5217107-21710799.756100.59
6211599-21159997.22598.04
极限1216233-21623399.35598.681.08100.3599.671.08
2216462-21646299.460100.46
3212588-21258897.68098.66
4215036-21503698.80599.80
5216968-21696899.692100.69
6211325-21132597.09998.08
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%
117.901963491965421962801962151962071963190.07
217.711961461960471960960.04
单位质量响应值RSD%判断
10967.5411072.610.68数据可信
供试品溶液-2022072301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%
5min1211534-21153497.19797.331.2497.2097.321.23
2212943-21294397.84497.84
3212476-21247697.63097.63
4215617-21561799.07399.07
5210499-21049996.72196.72
6207814-20781495.48895.49
10min1213577-21357798.13699.583.2498.3099.743.24
2214811-21481198.70398.87
3229579-229579105.488105.65
4219386-219386100.805100.97
5213014-21301497.87798.04
6209919-20991996.45596.61
15min1213642-21364298.16698.361.3498.4998.691.34
2214830-21483098.71199.04
3214342-21434298.48798.83
4218763-218763100.519100.85
5212872-21287297.81298.14
6209992-20999296.48896.81
20min1212853-21285397.80398.111.4898.2998.601.48
2215050-21505098.81399.30
3213587-21358798.14098.64
4218344-218344100.326100.83
5212566-21256697.67198.16
6208760-20876095.92296.40
30min1212461-21246197.62397.871.3798.2898.531.37
2213656-21365698.17298.83
3213301-21330198.00998.68
4217762-217762100.059100.73
5212011-21201197.41698.07
6208795-20879595.93896.58
45min1212477-21247797.63097.971.3998.4598.791.40
2213485-21348598.09398.91
3214081-21408198.36799.20
4218071-218071100.201101.04
5212255-21225597.52898.34
6208979-20897996.02396.82
极限1211408-21140897.13997.501.3998.1298.481.39
2213066-21306697.90198.88
3212522-21252297.65198.64
4216956-21695699.688100.69
5211286-21128697.08398.06
6207952-20795295.55196.51
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%
117.901965131962951959871956601958001960510.18
217.711962221958521960370.14
单位质量响应值RSD%判断
10952.5711069.280.75数据可信
供试品溶液-2022072401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%
5min1214586-21458698.68299.171.0198.6899.171.01
2216067-21606799.36399.36
3214173-21417398.49298.49
4218407-218407100.439100.44
5217782-217782100.152100.15
6212866-21286697.89197.89
10min1216462-21646299.545100.541.1899.71100.711.18
2218840-218840100.638100.80
3217528-217528100.035100.20
4221359-221359101.797101.96
5221922-221922102.055102.22
6215688-21568899.18999.35
15min1216716-21671699.661100.301.0299.99100.631.02
2218727-218727100.586100.92
3216590-21659099.60399.93
4220377-220377101.345101.68
5220812-220812101.545101.88
6215407-21540799.05999.39
20min1216046-21604699.353100.141.1999.85100.641.19
2218565-218565100.512101.01
3215826-21582699.25299.75
4220576-220576101.436101.94
5220754-220754101.518102.02
6214776-21477698.76999.26
30min1215431-21543199.07099.871.0899.73100.541.08
2217571-217571100.055100.72
3215843-21584399.26099.92
4219902-219902101.126101.80
5219870-219870101.112101.79
6214415-21441598.60399.26
45min1215199-21519998.964100.402.4799.79101.242.46
2217573-217573100.055100.89
3215299-21529999.01099.84
4228590-228590105.122105.97
5219389-219389100.891101.73
6213937-21393798.38399.21
极限1214345-21434598.57199.391.0499.56100.391.05
2217006-21700699.795100.80
3214783-21478398.77299.77
4218510-218510100.486101.51
5218673-218673100.561101.57
6213418-21341898.14599.13
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%
117.901957971958361957001955521955121956790.08
217.711956461957861957160.06
单位质量响应值RSD%判断
10931.7911051.160.77数据可信
供试品溶液-2022072401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%
5min1223803-223803103.103100.252.38103.10100.252.38
2214904-21490499.00399.00
3224602-224602103.471103.47
4215535-21553599.29499.29
5213524-21352498.36798.37
6213328-21332898.27798.28
10min1218699-218699100.751100.932.01100.92101.102.01
2217156-217156100.041100.21
3227771-227771104.931105.10
4218605-218605100.708100.87
5216285-21628599.63999.80
6216008-21600899.51299.68
15min1218767-218767100.783100.701.95101.12101.041.94
2216468-21646899.724100.06
3226867-226867104.514104.86
4218095-218095100.473100.81
5215561-21556199.30699.64
6215826-21582699.42899.76
20min1218947-218947100.866100.622.01101.37101.122.01
2216106-21610699.557100.05
3226887-226887104.524105.05
4217618-217618100.253100.75
5214985-21498599.04099.54
6215941-21594199.48199.98
30min1217719-217719100.300100.923.04100.98101.593.04
2215692-21569299.366100.03
3232479-232479107.100107.80
4217585-217585100.238100.91
5215367-21536799.21699.88
6215508-21550899.28199.94
45min1217415-217415100.160100.231.90101.00101.061.90
2215397-21539799.230100.06
3225670-225670103.963104.84
4217115-217115100.022100.86
5214786-21478698.94999.77
6214971-21497199.03499.86
极限1216487-21648799.73299.851.93100.74100.861.93
2214594-21459498.86099.86
3225045-225045103.675104.72
4215882-21588299.454100.46
5214149-21414998.65599.65
6214280-21428098.71699.71
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