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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.033690043695963696593700523698673696360.11
212.02 3697013684723690860.24
单位质量响应值RSD%判断
30726.1830705.990.05数据可信
供试品溶液-1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%
5min1388558-38855895.88495.511.6695.8895.511.66
2396671-39667197.88697.89
3381439-38143994.12794.13
4391394-39139496.58396.58
5379639-37963993.68393.68
6384636-38463694.91694.92
10min1400927-40092798.93698.441.3799.1098.601.37
2407127-407127100.466100.63
3394556-39455697.36497.52
4398596-39859698.36198.52
5400691-40069198.87899.03
6391588-39158896.63196.79
15min1401106-40110698.98098.391.2599.3098.721.25
2405753-405753100.127100.46
3394755-39475597.41397.73
4399010-39901098.46398.79
5400123-40012398.73799.06
6391581-39158196.63096.95
20min1400692-40069298.87898.361.3199.3798.851.30
2405832-405832100.146100.64
3395085-39508597.49497.98
4399318-39931898.53999.03
5399936-39993698.69199.18
6390663-39066396.40396.88
30min1400165-40016598.74898.241.3099.4098.891.30
2405259-405259100.005100.67
3394794-39479497.42298.07
4399130-39913098.49299.15
5399186-39918698.50699.16
6390031-39003196.24796.89
45min1399315-39931598.53898.151.2099.3698.961.20
2404292-40429299.766100.60
3395138-39513897.50798.31
4398805-39880598.41299.23
5398787-39878798.40899.22
6390084-39008496.26097.06
60min1397987-39798798.21097.911.1099.1998.891.10
2403400-40340099.546100.54
3394638-39463897.38498.35
4396629-39662997.87598.86
5397804-39780498.16599.14
6390237-39023796.29897.26
90min1397026-39702697.97397.731.2299.1298.871.22
2403091-40309199.470100.63
3393813-39381397.18098.31
4396498-39649897.84398.99
5397409-39740998.06899.21
6388416-38841695.84996.97
120min1-0.0000.00-1.311.301.35
2-0.0001.33
3-0.0001.29
4-0.0001.31
5-0.0001.31
6-0.0001.28
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1-0.0000.00-1.311.301.35
2-0.0001.33
3-0.0001.29
4-0.0001.31
5-0.0001.31
6-0.0001.28
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.033703763698333705833707883704133703990.10
212.02 3712793711813712300.02
单位质量响应值RSD%判断
30789.6130884.360.22数据可信
供试品溶液-1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%
5min1392002-39200296.35493.302.5496.3593.302.54
2387160-38716095.16495.16
3385037-38503794.64294.64
4369492-36949290.82190.82
5370713-37071391.12291.12
6373069-37306991.70191.70
10min1405535-40553599.68196.112.6999.8496.262.69
2400239-40023998.37998.54
3393166-39316696.64196.80
4384127-38412794.41994.57
5378325-37832592.99393.14
6384535-38453594.51994.67
15min1402536-40253698.94495.392.7599.2795.712.75
2396267-39626797.40397.73
3392088-39208896.37696.69
4384387-38438794.48394.79
5377427-37742792.77293.08
6375825-37582592.37892.69
20min1402287-40228798.88295.632.5599.3796.102.55
2396962-39696297.57498.06
3393587-39358796.74497.22
4382759-38275994.08294.55
5380315-38031593.48293.94
6378330-37833092.99493.46
30min1404837-40483799.50995.382.93100.1796.022.93
2395891-39589197.31097.96
3390575-39057596.00496.64
4384623-38462394.54195.16
5377061-37706192.68293.30
6375287-37528792.24692.87
45min1401464-40146498.68095.112.5599.5095.902.55
2396872-39687297.55198.36
3379023-37902393.16493.96
4385201-38520194.68395.46
5378921-37892193.13993.91
6380258-38025893.46894.24
60min1401715-40171598.74295.382.4999.7396.332.50
2396234-39623497.39598.37
3389935-38993595.84696.80
4382731-38273194.07695.01
5376785-37678592.61493.54
6380707-38070793.57894.51
90min1396585-39658597.48195.242.1498.6396.352.15
2394385-39438596.94098.07
3393354-39335496.68797.80
4383473-38347394.25895.35
5378071-37807192.93094.01
6378895-37889593.13394.22
120min1-0.0000.00-1.311.272.44
2-0.0001.30
3-0.0001.28
4-0.0001.25
5-0.0001.24
6-0.0001.24
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1-0.0000.00-1.311.272.44
2-0.0001.30
3-0.0001.28
4-0.0001.25
5-0.0001.24
6-0.0001.24
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.033695033694843692833695043694203694390.03
212.02 3702653705223703940.05
单位质量响应值RSD%判断
30709.8130814.810.25数据可信
供试品溶液-1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1207744-20774451.18847.918.5251.1947.918.52
2168379-16837941.48841.49
3208050-20805051.26351.26
4200093-20009349.30249.30
5202932-20293250.00250.00
6179414-17941444.20744.21
10min1245511-24551160.49357.466.8560.5857.546.85
2207719-20771951.18151.25
3248531-24853161.23761.32
4235709-23570958.07858.16
5241412-24141259.48359.57
6220341-22034154.29154.37
15min1272080-27208067.04064.126.2167.2364.306.22
2231164-23116456.95857.11
3272369-27236967.11167.30
4266364-26636465.63165.81
5267925-26792566.01666.20
6251518-25151861.97362.14
20min1292040-29204071.95869.435.5972.2669.725.60
2252669-25266962.25762.51
3293863-29386372.40772.71
4287193-28719370.76471.05
5289960-28996071.44571.74
6275050-27505067.77268.04
30min1320989-32098979.09177.434.6379.5177.824.64
2286203-28620370.52070.87
3324711-32471180.00880.43
4318315-31831578.43278.84
5323665-32366579.75080.16
6311540-31154076.76377.14
45min1343963-34396384.75283.604.1885.3084.134.19
2311311-31131176.70677.18
3348653-34865385.90786.46
4342933-34293384.49885.03
5349208-34920886.04486.59
6339711-33971183.70484.21
60min1358928-35892888.43987.613.8989.1388.283.90
2328259-32825980.88281.48
3363311-36331189.51990.22
4358076-35807688.22988.91
5366749-36674990.36691.05
6358091-35809188.23388.88
90min1370885-37088591.38590.933.5292.2291.753.53
2343645-34364584.67385.41
3373843-37384392.11492.96
4373848-37384892.11592.94
5380955-38095593.86694.70
6371162-37116291.45392.25
120min1381304-38130493.95292.993.4894.9493.963.49
2351769-35176986.67587.55
3386929-38692995.33896.34
4379174-37917493.42894.41
5387060-38706095.37196.37
6378269-37826993.20594.15
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1379120-37912093.41493.234.0894.5694.354.09
2347676-34767685.66786.69
3385500-38550094.98696.14
4382437-38243794.23295.37
5389262-38926295.91397.07
6386312-38631295.18696.29
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