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 12.103879463879253876203878983874623877700.06
2 12.013877543864043870790.25
单位质量响应值RSD%判断
32047.1132229.730.41数据可信
供试品溶液-6021201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%
5min1187121-18712143.94748.986.8743.9548.986.87
2213444-21344450.12950.13
3226785-22678553.26253.26
4199239-19923946.79346.79
5219216-21921651.48551.48
6205444-20544448.25048.25
10min1251591-25159159.08861.913.1259.1662.003.13
2267688-26768862.86962.95
3275196-27519664.63264.72
4257537-25753760.48560.56
5265875-26587562.44362.53
6263860-26386061.97062.05
15min1287140-28714067.43769.482.6467.6169.672.64
2296430-29643069.61969.81
3309155-30915572.60872.80
4288965-28896567.86668.04
5297658-29765869.90770.10
6295768-29576869.46469.65
20min1306426-30642671.96774.242.6272.2574.542.63
2316633-31663374.36474.67
3331194-33119477.78478.10
4311881-31188173.24873.54
5316003-31600374.21674.52
6314503-31450373.86474.16
30min1339864-33986479.82080.741.9980.2281.162.00
2347244-34724481.55381.98
3355692-35569283.53783.98
4336708-33670879.07979.49
5340169-34016979.89180.32
6342936-34293680.54180.96
45min1361009-36100984.78685.621.5285.3286.181.52
2369111-36911186.68987.25
3371761-37176187.31187.90
4364995-36499585.72286.27
5356393-35639383.70284.27
6364122-36412285.51786.07
60min1370642-37064287.04888.392.4287.7389.102.41
2392662-39266292.22092.93
3379700-37970089.17689.91
4366655-36665586.11286.80
5374082-37408287.85688.56
6374464-37446487.94688.65
90min1391847-39184792.02890.231.5992.8591.081.58
2386636-38663690.80591.67
3389264-38926491.42292.30
4379210-37921089.06189.89
5376121-37612188.33589.18
6382156-38215689.75290.60
120min1385711-38571190.58790.811.4691.5691.811.46
2392546-39254692.19393.21
3391597-39159791.97093.00
4386849-38684990.85591.84
5376736-37673688.48089.48
6386579-38657990.79191.79
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1404439-40443994.98692.811.7196.1193.961.69
2400164-40016493.98295.15
3397170-39717093.27994.46
4387553-38755391.02092.15
5387952-38795291.11492.26
6393778-39377892.48293.63
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 12.103874723869953868693873883866403870730.10
2 12.013869293871153870220.04
单位质量响应值RSD%判断
31989.5032224.980.52数据可信
供试品溶液-6021201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%
5min1191811-19181145.09247.0711.8045.0947.0711.80
2210376-21037649.45749.46
3184508-18450843.37643.38
4197783-19778346.49646.50
5241767-24176756.83656.84
6175030-17503041.14741.15
10min1259005-25900560.88960.666.8060.9660.746.81
2266182-26618262.57662.66
3243472-24347257.23757.31
4255145-25514559.98160.06
5286857-28685767.43767.53
6237531-23753155.84155.91
15min1288506-28850667.82468.405.6968.0068.585.70
2297055-29705569.83470.02
3280433-28043365.92666.09
4285383-28538367.09067.27
5320694-32069475.39175.60
6273716-27371664.34764.51
20min1313164-31316473.62173.824.6273.9174.124.63
2317268-31726874.58674.89
3305516-30551671.82372.10
4306476-30647672.04972.34
5341027-34102780.17180.50
6300667-30066770.68370.95
30min1341873-34187380.37080.113.9680.7880.533.97
2339045-33904579.70580.13
3337422-33742279.32479.72
4331183-33118377.85778.27
5366370-36637086.12986.60
6328749-32874977.28577.67
45min1369258-36925886.80885.634.9787.3586.184.97
2354992-35499283.45484.01
3372198-37219887.49988.03
4347643-34764381.72782.27
5394221-39422192.67693.29
6347242-34724281.63282.15
60min1378412-37841288.96087.003.1489.6587.693.14
2364069-36406985.58886.29
3372472-37247287.56488.24
4358554-35855484.29284.97
5387641-38764191.13091.89
6359179-35917984.43985.09
90min1386365-38636590.83089.313.2291.6790.153.23
2371932-37193287.43788.28
3383358-38335890.12390.94
4365832-36583286.00386.82
5399371-39937193.88794.80
6372644-37264487.60488.40
120min1391408-39140892.01589.993.6493.0190.983.64
2374833-37483388.11989.11
3384091-38409190.29591.27
4369425-36942586.84787.81
5405547-40554795.33996.41
6371387-37138787.30888.25
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1394650-39465092.77790.852.7493.9291.982.74
2379248-37924889.15690.29
3396813-39681393.28694.41
4375491-37549188.27389.38
5396544-39654493.22394.45
6375908-37590888.37189.46
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 12.103871823863573858883865883866453865320.13
2 12.013867543867193867360.01
单位质量响应值RSD%判断
31944.7932201.170.57数据可信
供试品溶液-6021301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%
5min1204856-20485648.21150.454.5548.2150.454.54
2228580-22858053.79453.79
3217835-21783551.26551.27
4201947-20194747.52647.53
5214807-21480750.55350.55
6218212-21821251.35451.35
10min1255217-25521760.06361.665.0460.1461.745.03
2285817-28581767.26467.35
3263199-26319961.94162.03
4246968-24696858.12158.20
5256987-25698760.47960.56
6263738-26373862.06862.15
15min1283793-28379366.78867.092.4466.9767.272.44
2289450-28945068.11968.32
3289071-28907168.03068.22
4272216-27221664.06364.24
5284537-28453766.96367.15
6291294-29129468.55368.74
20min1302308-30230871.14572.652.1871.4472.952.18
2312235-31223573.48173.80
3315222-31522274.18474.49
4298364-29836470.21770.50
5311580-31158073.32773.62
6312445-31244573.53173.83
30min1327147-32714776.99178.601.8677.4079.021.86
2337024-33702479.31579.75
3337656-33765679.46479.89
4330433-33043377.76478.16
5328674-32867477.35077.77
6342981-34298180.71781.14
45min1348925-34892582.11683.781.9282.6584.331.92
2354579-35457983.44684.02
3361299-36129985.02885.59
4352975-35297583.06983.60
5351220-35122082.65683.20
6366996-36699686.36986.93
60min1360090-36009084.74386.671.8085.4287.371.80
2366776-36677686.31787.03
3376713-37671388.65589.36
4366243-36624386.19186.86
5364179-36417985.70686.39
6375761-37576188.43189.14
90min1371800-37180087.49989.631.9188.3290.461.91
2379485-37948589.30890.16
3386061-38606190.85591.70
4379739-37973989.36790.18
5375904-37590488.46589.29
6392107-39210792.27893.13
120min1380134-38013489.46091.191.7190.4292.171.71
2384232-38423290.42591.43
3392601-39260192.39493.39
4386684-38668491.00291.96
5383310-38331090.20891.18
6397955-39795593.65494.66
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1380689-38068989.59191.651.9190.7092.791.91
2388492-38849291.42792.58
3397933-39793393.64994.80
4383861-38386190.33891.45
5386830-38683091.03692.16
6398855-39885593.86695.03
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 12.103869443872663877423870003876003873100.10
2 12.013882203882033882120.01
单位质量响应值RSD%判断
32009.0932324.060.70数据可信
供试品溶液-6021301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%
5min1214665-21466550.37349.982.5550.3749.982.55
2206961-20696148.56548.56
3207145-20714548.60848.61
4211300-21130049.58349.58
5218510-21851051.27551.27
6219350-21935051.47251.47
10min1255327-25532759.91460.883.9960.0060.973.99
2251397-25139758.99259.07
3252387-25238759.22459.31
4254295-25429559.67259.75
5265457-26545762.29162.38
6277898-27789865.21165.30
15min1286197-28619767.15867.862.2167.3468.042.21
2283111-28311166.43466.61
3281858-28185866.14066.32
4292451-29245168.62568.81
5293969-29396968.98269.17
6297550-29755069.82270.02
20min1312252-31225273.27272.752.1673.5773.042.16
2304151-30415171.37171.66
3303528-30352871.22571.51
4305262-30526271.63271.93
5315322-31532273.99274.30
6319534-31953474.98175.29
30min1346899-34689981.40283.009.6581.8283.429.60
2331312-33131277.74478.15
3335601-33560178.75179.16
4422166-42216699.06499.48
5339393-33939379.64180.07
6346857-34685781.39281.83
45min1373216-37321687.57885.482.4988.1386.032.49
2349301-34930181.96682.50
3357488-35748883.88784.43
4367444-36744486.22386.80
5367436-36743686.22186.78
6370648-37064886.97587.55
60min1384906-38490690.32189.453.2891.0290.153.27
2362438-36243885.04885.72
3370888-37088887.03187.71
4385610-38561090.48691.21
5397534-39753493.28493.99
6385779-38577990.52591.24
90min1396714-39671493.09192.113.1893.9492.963.18
2372048-37204887.30388.12
3383032-38303289.88190.71
4405233-40523395.09095.97
5398075-39807593.41194.27
6400185-40018593.90694.77
120min1408258-40825895.80093.363.2996.8194.373.28
2376596-37659688.37189.33
3387506-38750690.93191.91
4408256-40825695.80096.83
5400338-40033893.94294.96
6406317-40631795.34596.37
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1413282-41328296.97995.233.5798.1496.383.56
2384464-38446490.21791.33
3393941-39394192.44193.57
4410952-41095296.43297.63
5407263-40726395.56796.74
6424939-42493999.715100.90
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