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 11.963740413739853740983735663742243739830.07
2 12.003735943738413737180.05
单位质量响应值RSD%判断
31269.4831143.170.29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%
5min1219631-21963153.12357.497.5653.1257.497.55
2241157-24115758.32958.33
3247814-24781459.93959.94
4227607-22760755.05255.05
5223073-22307353.95553.96
6266930-26693064.56364.56
10min1261273-26127363.19566.095.1563.2866.195.15
2273872-27387266.24266.34
3287173-28717369.45969.56
4261891-26189163.34463.44
5262164-26216463.41063.50
6293194-29319470.91571.02
15min1292818-29281870.82573.064.2871.0273.264.28
2298381-29838172.17072.38
3318143-31814376.95077.17
4288165-28816569.69969.90
5296775-29677571.78271.98
6317996-31799676.91477.14
20min1318698-31869877.08477.744.8377.4078.074.83
2321453-32145377.75178.08
3340929-34092982.46182.81
4301091-30109172.82673.14
5309156-30915674.77675.09
6337185-33718581.55681.91
30min1344780-34478083.39384.153.2983.8384.603.30
2349998-34999884.65585.11
3365860-36586088.49188.97
4330944-33094480.04680.48
5344035-34403583.21283.65
6351851-35185185.10385.59
45min1369821-36982189.44989.562.9590.0390.162.96
2370666-37066689.65490.25
3386372-38637293.45394.08
4354936-35493685.84986.42
5362891-36289187.77388.35
6377010-37701091.18891.82
60min1379630-37963091.82291.812.8292.5592.562.83
2384183-38418392.92393.67
3395431-39543195.64496.43
4366613-36661388.67389.38
5368669-36866989.17189.90
6382942-38294292.62393.41
90min1389307-38930794.16394.271.6895.0495.171.70
2390843-39084394.53495.44
3398838-39883896.46897.41
4383860-38386092.84593.70
5381224-38122492.20793.08
6394522-39452295.42496.36
120min1394276-39427695.36495.711.8896.4096.771.89
2398179-39817996.30897.37
3406616-40661698.34999.45
4392015-39201594.81895.83
5384498-38449892.99994.03
6398635-39863596.41997.52
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1403932-40393297.70097.151.5398.9098.371.55
2398192-39819296.31297.53
3409917-40991799.148100.42
4397905-39790596.24297.41
5393574-39357495.19596.38
6406540-40654098.33199.59
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 11.963735573738943739393738213743613739140.08
2 12.003740653739983740320.02
单位质量响应值RSD%判断
31263.7131169.330.22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%
5min1241734-24173458.45055.6117.2558.4555.6217.24
2204915-20491549.54749.55
3162775-16277539.35839.36
4250778-25077860.63660.64
5273240-27324066.06766.07
6246585-24658559.62259.62
10min1275099-27509966.51765.5811.3366.6165.6711.34
2247525-24752559.85059.93
3222049-22204953.69053.76
4294095-29409571.11071.21
5302684-30268473.18773.30
6285804-28580469.10569.20
15min1310100-31010074.98072.399.0675.1972.609.07
2276405-27640566.83367.02
3256189-25618961.94562.10
4318639-31863977.04577.26
5325674-32567478.74678.98
6309437-30943774.82075.03
20min1331384-33138480.12677.607.1680.4677.927.18
2298286-29828672.12372.42
3286366-28636669.24169.50
4339031-33903181.97582.32
5341810-34181082.64783.01
6328637-32863779.46279.80
30min1352068-35206885.12783.904.6685.5984.354.69
2328304-32830479.38279.80
3326481-32648178.94179.31
4361442-36144287.39487.88
5364167-36416788.05388.55
6349507-34950784.50884.98
45min1375398-37539890.76989.403.9591.3889.993.97
2348229-34822984.19984.75
3359987-35998787.04287.55
4385857-38585793.29793.93
5383660-38366092.76693.41
6365186-36518688.29988.91
60min1396896-39689695.96792.554.1496.7393.294.15
2358484-35848486.67987.37
3377453-37745391.26591.92
4396019-39601995.75596.54
5395168-39516895.54996.35
6372606-37260690.09390.85
90min1398943-39894396.46294.803.5497.3895.703.55
2370203-37020389.51290.34
3392335-39233594.86495.67
4406857-40685798.37599.32
5402401-40240197.29898.26
6381683-38168392.28893.20
120min1410188-41018899.18095.263.94100.2696.313.95
2369801-36980189.41590.40
3389250-38925094.11895.08
4404091-40409197.70698.82
5405866-40586698.13599.26
6384626-38462693.00094.06
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1417291-417291100.89897.403.76102.1498.613.75
2383814-38381492.80393.93
3406847-40684798.37399.49
4414762-414762100.286101.56
5410285-41028599.204100.49
6383884-38388492.82094.04
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 11.963736423742523743093734513739803739270.11
2 12.003745513743803744660.04
单位质量响应值RSD%判断
31264.8031205.500.14数据可信
供试品溶液-6021401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%
5min1264920-26492064.01761.676.5164.0261.676.51
2270914-27091465.46665.47
3231505-23150555.94355.94
4238476-23847657.62757.63
5256249-25624961.92261.92
6269133-26913365.03665.04
10min1296567-29656771.66569.705.1771.7769.815.17
2298794-29879472.20372.31
3263242-26324263.61263.71
4277039-27703966.94667.04
5295665-29566571.44771.55
6299422-29942272.35572.46
15min1318717-31871777.01776.075.0477.2476.295.04
2327076-32707679.03779.27
3289106-28910669.86270.06
4301849-30184972.94173.15
5323689-32368978.21978.44
6328280-32828079.32879.56
20min1335448-33544881.06080.444.6181.4180.784.62
2344450-34445083.23683.60
3309631-30963174.82275.14
4318577-31857776.98477.31
5347543-34754383.98384.34
6341576-34157682.54182.90
30min1363583-36358387.85986.503.2788.3586.983.28
2362597-36259787.62188.12
3338427-33842781.78082.22
4349189-34918984.38184.84
5369333-36933389.24989.74
6364515-36451588.08488.58
45min1381546-38154692.20091.583.4192.8492.203.41
2374360-37436090.46391.11
3365229-36522988.25788.83
4368330-36833089.00689.60
5400890-40089096.87497.52
6383491-38349192.67093.32
60min1393857-39385795.17594.713.7395.9695.493.72
2389623-38962394.15294.95
3377319-37731991.17891.90
4380007-38000791.82892.57
5418368-418368101.098101.90
6392493-39249394.84595.65
90min1405368-40536897.95697.393.0498.9098.333.05
2401513-40151397.02597.98
3394329-39432995.28996.16
4390291-39029194.31395.21
5425429-425429102.804103.78
6401290-40129096.97197.93
120min1408381-40838198.68598.093.0799.8099.183.07
2402627-40262797.29498.41
3398997-39899796.41797.45
4392466-39246694.83995.90
5428826-428826103.625104.77
6404156-40415697.66498.78
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1415198-415198100.33299.002.85101.61100.262.85
2405088-40508897.88999.17
3402645-40264597.29898.49
4395067-39506795.46796.68
5428642-428642103.581104.90
6411558-41155899.452100.73
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