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%
1 12.103846643838533831963841633854513842650.23
2 12.133837853836563837200.03
单位质量响应值RSD%判断
31757.4431633.970.28数据可信
供试品溶液-6031101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%
5min1220837-22083752.59048.6916.8052.5948.6916.80
2177178-17717842.19342.19
3152560-15256036.33036.33
4211402-21140250.34350.34
5249421-24942159.39759.40
6215368-21536851.28751.29
10min1255328-25532860.80357.1713.5060.8957.2513.50
2213987-21398750.95851.03
3190431-19043145.34945.41
4247125-24712558.85058.93
5280792-28079266.86766.97
6252713-25271360.18060.27
15min1277290-27729066.03364.2910.4166.2264.4710.42
2250546-25054659.66459.82
3227684-22768454.22054.36
4274806-27480665.44265.62
5310187-31018773.86774.08
6279347-27934766.52366.71
20min1302710-30271072.08769.968.4672.3970.258.48
2273612-27361265.15765.41
3258559-25855961.57361.80
4300178-30017871.48471.77
5329873-32987378.55578.89
6297863-29786370.93271.23
30min1330962-33096278.81577.676.0379.2378.076.06
2314744-31474474.95275.32
3297850-29785070.92971.26
4329826-32982678.54478.95
5357166-35716685.05585.52
6326438-32643877.73778.15
45min1353452-35345284.17084.274.1284.7284.804.15
2349287-34928783.17883.67
3332323-33232379.13979.59
4357439-35743985.12085.66
5377587-37758789.91890.52
6353163-35316384.10184.65
60min1367188-36718887.44188.363.7288.1389.023.76
2365589-36558987.06087.69
3353649-35364984.21784.80
4370410-37041088.20988.89
5395464-39546494.17594.93
6373856-37385689.02989.71
90min1378057-37805790.03091.813.3690.8792.633.39
2386702-38670292.08892.86
3369406-36940687.96988.69
4384029-38402991.45292.28
5408188-40818897.20598.12
6386817-38681792.11692.95
120min1381518-38151890.85492.742.9891.8493.713.01
2389928-38992892.85793.78
3376082-37608289.55990.43
4386325-38632591.99992.98
5409592-40959297.53998.61
6393123-39312393.61794.60
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1386953-38695392.14894.192.5893.2995.322.60
2400160-40016095.29396.37
3383567-38356791.34292.36
4394075-39407593.84494.98
5412150-41215098.14899.39
6396301-39630194.37495.52
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%
1 12.103827003850223838403848913827043838310.30
2 12.133856963849493853220.14
单位质量响应值RSD%判断
31721.5731766.030.10数据可信
供试品溶液-6031102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%
5min1160635-16063538.19541.3917.4538.2041.3917.45
2205212-20521248.79448.79
3119795-11979528.48428.48
4179650-17965042.71642.72
5190630-19063045.32745.33
6188526-18852644.82744.83
10min1223000-22300053.02453.628.7953.0953.708.80
2247616-24761658.87758.96
3189155-18915544.97745.02
4225612-22561253.64553.72
5235407-23540755.97456.05
6232374-23237455.25355.33
15min1261180-26118062.10262.216.4662.2562.376.48
2282575-28257567.19067.37
3231133-23113354.95855.08
4261717-26171762.23062.39
5268655-26865563.88064.05
6264598-26459862.91563.08
20min1289947-28994768.94268.215.5469.2068.475.56
2304798-30479872.47472.77
3257381-25738161.19961.41
4287564-28756468.37668.64
5294554-29455470.03870.31
6286842-28684268.20468.48
30min1326082-32608277.53475.803.6077.9076.183.62
2329812-32981278.42178.83
3298693-29869371.02271.34
4321323-32132376.40376.78
5324444-32444477.14577.54
6312497-31249774.30474.69
45min1351608-35160883.60482.002.9484.1082.502.96
2354733-35473384.34784.89
3327857-32785777.95778.39
4348085-34808582.76683.27
5349220-34922083.03683.56
6337672-33767280.29080.80
60min1361949-36194986.06384.802.1386.7085.442.15
2361374-36137485.92686.61
3344100-34410081.81982.38
4358033-35803385.13285.78
5363353-36335386.39787.06
6350990-35099083.45784.10
90min1378575-37857590.01687.972.2590.8088.752.28
2377462-37746289.75190.58
3357156-35715684.92385.62
4369231-36923187.79488.58
5373557-37355788.82389.63
6363769-36376986.49687.28
120min1379097-37909790.14089.192.2591.0790.122.28
2383970-38397091.29992.28
3361565-36156585.97186.81
4378011-37801189.88290.81
5379750-37975090.29591.25
6368162-36816287.54088.47
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1390272-39027292.79792.001.8693.8893.081.88
2393759-39375993.62694.75
3377582-37758289.78090.77
4388545-38854592.38793.47
5392954-39295493.43594.54
6378376-37837689.96991.04
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%
1 12.103846893849793820823844513855473843500.35
2 12.133850173827153838660.43
单位质量响应值RSD%判断
31764.4631646.000.27数据可信
供试品溶液-6031103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%
5min1154451-15445136.77042.2111.1536.7742.2111.15
2168276-16827640.06140.06
3203043-20304348.33848.34
4200285-20028547.68147.68
5165967-16596739.51139.51
6171816-17181640.90440.90
10min1201503-20150347.97153.387.9748.0353.457.98
2221154-22115452.64952.72
3247548-24754858.93359.01
4242920-24292057.83157.91
5211402-21140250.32850.39
6220736-22073652.55052.62
15min1241500-24150057.49361.616.1057.6361.766.11
2256716-25671661.11561.27
3278367-27836766.27066.45
4277456-27745666.05366.23
5245549-24554958.45758.61
6253053-25305360.24360.40
20min1270079-27007964.29767.574.3864.5367.834.39
2282597-28259767.27767.53
3295896-29589670.44370.73
4301000-30100071.65871.94
5272321-27232164.83065.08
6280985-28098566.89367.15
30min1305367-30536772.69775.152.8573.0475.522.87
2312564-31256474.41174.78
3326514-32651477.73278.14
4327062-32706277.86278.27
5310781-31078173.98674.34
6311640-31164074.19174.56
45min1329758-32975878.50480.902.3878.9781.402.40
2341344-34134481.26281.75
3345828-34582882.33082.87
4351429-35142983.66384.20
5337536-33753680.35680.83
6333094-33309479.29879.79
60min1344377-34437781.98483.472.0682.5884.102.07
2356234-35623484.80785.44
3350732-35073283.49784.17
4360896-36089685.91786.59
5350017-35001783.32783.94
6341440-34144081.28581.91
90min1355213-35521384.56486.651.6885.3087.431.70
2364826-36482686.85387.62
3368813-36881387.80288.61
4372218-37221888.61289.43
5362931-36293186.40287.15
6359932-35993285.68886.45
120min1367704-36770487.53888.411.3488.4189.321.36
2372310-37231088.63489.55
3376128-37612889.54390.50
4377691-37769189.91590.88
5369325-36932587.92488.82
6364964-36496486.88687.79
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1379362-37936290.31391.411.3791.3392.481.39
2385805-38580591.84792.91
3391253-39125393.14494.25
4388118-38811892.39893.51
5378102-37810290.01391.06
6381271-38127190.76891.81
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