盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.963886343887563887023882283879813884600.09
212.003891533887383889460.08
单位质量响应值RSD%判断
32479.9332412.170.15数据可信
供试品溶液-6021401批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1424864-42486498.83699.122.9798.8499.122.97
2442587-442587102.959102.96
3427999-42799999.56599.57
4434738-434738101.133101.13
5405759-40575994.39294.39
6420550-42055097.83297.83
10min1428700-42870099.728100.052.6199.89100.212.61
2443639-443639103.204103.38
3431130-431130100.294100.46
4440264-440264102.419102.59
5412875-41287596.04796.20
6423777-42377798.58398.75
15min1427513-42751399.452100.162.6899.78100.492.68
2445761-445761103.697104.04
3431237-431237100.319100.65
4440594-440594102.495102.83
5413685-41368596.23596.55
6424475-42447598.74699.07
20min1427982-42798299.561100.172.58100.06100.672.59
2445311-445311103.593104.11
3430681-430681100.189100.69
4440734-440734102.528103.04
5414932-41493296.52697.00
6423902-42390298.61299.10
30min1426762-42676299.27899.952.4699.94100.612.46
2443891-443891103.262103.95
3429624-42962499.943100.61
4439273-439273102.188102.87
5415139-41513996.57497.21
6423129-42312998.43299.09
45min1425928-42592899.08499.832.4299.91100.662.42
2443525-443525103.177104.04
3429019-42901999.803100.64
4438604-438604102.032102.88
5415690-41569096.70297.50
6422139-42213998.20299.02
60min1425419-42541998.96599.702.4699.96100.702.46
2442977-442977103.050104.08
3428515-42851599.685100.69
4438342-438342101.971102.99
5414718-41471896.47697.44
6421525-42152598.05999.04
极限1423893-42389398.61099.502.4399.77100.672.43
2441703-441703102.753103.96
3427264-42726499.394100.56
4438196-438196101.937103.13
5414929-41492996.52597.65
6420356-42035697.78798.93
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.963876693886293889933883063889163885030.14
212.003896573889963893260.13
单位质量响应值RSD%判断
32483.5332443.830.09数据可信
供试品溶液-6021401批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1429054-42905499.75699.152.9999.7699.152.99
2434928-434928101.122101.12
3432148-432148100.476100.48
4421772-42177298.06398.06
5437742-437742101.776101.78
6403044-40304493.70993.71
10min1431938-431938100.427100.671.77100.59100.841.78
2439321-439321102.144102.31
3438397-438397101.929102.10
4424287-42428798.64898.81
5440535-440535102.426102.60
6423494-42349498.46498.62
15min1431338-431338100.288100.751.75100.62101.081.75
2440115-440115102.328102.67
3438084-438084101.856102.19
4423520-42352098.47098.80
5441133-441133102.565102.91
6425786-42578698.99799.32
20min1432061-432061100.456100.831.55100.96101.341.56
2438917-438917102.050102.56
3438554-438554101.965102.47
4424640-42464098.73099.22
5440663-440663102.456102.97
6427285-42728599.34599.83
30min1430727-430727100.145100.611.60100.81101.281.60
2437754-437754101.779102.46
3437487-437487101.717102.39
4423305-42330598.42099.08
5440394-440394102.393103.08
6426601-42660199.18699.84
45min1429106-42910699.769100.421.56100.60101.261.56
2437402-437402101.697102.55
3437026-437026101.610102.46
4422741-42274198.28999.11
5438798-438798102.022102.87
6426384-42638499.13699.95
60min1428662-42866299.665100.231.61100.67101.241.62
2436180-436180101.413102.43
3436509-436509101.490102.51
4420926-42092697.86798.85
5438273-438273101.900102.92
6426108-42610899.072100.05
极限1427918-42791899.49299.991.52100.66101.171.52
2434491-434491101.021102.21
3435091-435091101.160102.35
4420765-42076597.82998.98
5437194-437194101.649102.84
6425005-42500598.81599.96
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.963898763894143892123898303895963895860.08
212.003901403898053899720.07
单位质量响应值RSD%判断
32574.0832497.670.17数据可信
供试品溶液-6021401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%
5min1385083-38508389.33592.114.3689.3392.114.36
2402201-40220193.30693.31
3370670-37067085.99185.99
4421082-42108297.68697.69
5404051-40405193.73593.73
6399154-39915492.59992.60
10min1413061-41306195.82595.872.2995.9796.022.29
2420286-42028697.50197.66
3398962-39896292.55492.70
4425915-42591598.80798.97
5413609-41360995.95296.11
6407617-40761794.56294.72
15min1415087-41508796.29596.571.7696.6096.881.76
2421499-42149997.78398.10
3406722-40672294.35494.65
4427677-42767799.21699.54
5413362-41336295.89596.21
6413344-41334495.89196.20
20min1415042-41504296.28595.143.6496.7595.613.63
2423126-42312698.16098.64
3407435-40743594.52094.97
4421206-42120697.71598.21
5411662-41166295.50195.98
6382080-38208088.63889.11
30min1418925-41892597.18596.062.7597.8196.692.74
2426205-42620598.87499.52
3409161-40916194.92095.53
4424769-42476998.54199.20
5396587-39658792.00392.64
6408688-40868894.81195.43
45min1416232-41623296.56196.211.7097.3597.011.70
2419664-41966497.35798.17
3403335-40333593.56994.34
4423334-42333498.20899.03
5415025-41502596.28197.07
6410837-41083795.30996.09
60min1419599-41959997.34296.651.5898.2997.601.58
2424739-42473998.53499.51
3413380-41338095.89996.83
4422489-42248998.01299.00
5410230-41023095.16896.12
6409228-40922894.93695.87
极限1419160-41916097.24096.112.5198.3597.222.50
2427361-42736199.142100.28
3406639-40663994.33595.42
4423705-42370598.29499.44
5403728-40372893.66094.77
6405106-40510693.98095.07
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.963884693883143890993884873888453886430.09
212.003880563884593882580.08
单位质量响应值RSD%判断
32495.2332354.830.31数据可信
供试品溶液-6021401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%
5min1415627-41562796.75095.086.4796.7595.086.47
2431546-431546100.456100.46
3416305-41630596.90896.91
4416576-41657696.97196.97
5356108-35610882.89582.90
6414651-41465196.52396.52
10min1419265-41926597.59798.971.8097.7699.131.80
2436914-436914101.705101.87
3424328-42432898.77698.94
4430576-430576100.230100.39
5415907-41590796.81596.95
6423954-42395498.68998.85
15min1419670-41967097.69198.641.6398.0298.971.63
2436420-436420101.590101.93
3425180-42518098.97499.30
4423550-42355098.59598.92
5416685-41668596.99797.30
6421025-42102598.00798.33
20min1420223-42022397.82098.961.7498.3199.451.74
2434942-434942101.246101.75
3424906-42490698.91099.40
4433322-433322100.869101.36
5417717-41771797.23797.70
6419674-41967497.69298.18
30min1416295-41629596.90698.101.2997.5698.761.29
2429948-429948100.084100.76
3425502-42550299.04999.70
4417900-41790097.27997.94
5417229-41722997.12397.75
6421707-42170798.16698.82
45min1417595-41759597.20898.861.3898.0299.681.38
2433181-433181100.836101.68
3424681-42468198.85899.68
4429720-429720100.031100.85
5420368-42036897.85498.64
6422667-42266798.38999.20
60min1421581-42158198.13699.151.4599.11100.141.46
2435376-435376101.347102.36
3425635-42563599.080100.07
4431388-431388100.419101.41
5420389-42038997.85998.81
6421323-42132398.07699.06
极限1412111-41211195.93297.921.5697.0799.071.56
2430772-430772100.276101.45
3414919-41491996.58597.74
4422520-42252098.35599.51
5421296-42129698.07099.18
6422347-42234798.31599.46
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