盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.213809913812883817533810273811673812450.09
212.133802453800443801440.04
单位质量响应值RSD%判断
31224.0031339.160.27数据可信
长期24月25℃-供试品溶液-2023120621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%
5min1233713-23371356.63055.922.5656.6355.922.56
2231151-23115156.01056.01
3232408-23240856.31456.31
4235848-23584857.14857.15
5232412-23241256.31556.32
6219219-21921953.11853.12
10min1265961-26596164.44462.644.5664.5762.764.56
2254475-25447561.66161.79
3264440-26444064.07664.20
4272151-27215165.94466.07
5255183-25518361.83361.96
6238753-23875357.85257.97
15min1285395-28539569.15367.063.4369.4267.323.42
2281939-28193968.31668.58
3279382-27938267.69667.96
4274897-27489766.61066.88
5280219-28021967.89968.16
6258724-25872462.69162.94
20min1289914-28991470.24869.992.3470.6770.402.34
2299574-29957472.58973.00
3290938-29093870.49670.91
4289300-28930070.10070.52
5282899-28289968.54968.96
6280347-28034767.93068.32
30min1299753-29975372.63272.442.4273.2173.002.40
2304931-30493173.88774.46
3297418-29741872.06772.64
4287104-28710469.56770.14
5307696-30769674.55775.12
6296838-29683871.92672.46
45min1316272-31627276.63577.141.0977.3877.861.08
2315628-31562876.47977.22
3314346-31434676.16876.90
4321494-32149477.90078.63
5322978-32297878.26078.99
6319318-31931877.37378.07
60min1334733-33473381.10880.772.2182.0281.672.19
2323702-32370278.43579.34
3339954-33995482.37383.28
4342405-34240582.96783.87
5332849-33284980.65281.56
6326377-32637779.08479.95
90min1351563-35156385.18684.661.3986.2885.741.37
2339874-33987482.35483.44
3351198-35119885.09886.19
4352981-35298185.53086.62
5349002-34900284.56685.65
6351730-35173085.22786.27
120min1348240-34824084.38186.692.1185.6687.962.08
2351390-35139085.14486.41
3358973-35897386.98288.26
4362238-36223887.77389.05
5369174-36917489.45490.73
6356707-35670786.43387.67
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1376016-37601691.11289.760.8492.5891.210.82
2368084-36808489.19090.64
3368335-36833589.25090.72
4370351-37035189.73991.21
5368128-36812889.20090.67
6371588-37158890.03991.46
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.213809683805433807253805833802813806200.07
212.133814963808933811940.12
单位质量响应值RSD%判断
31172.8131425.720.58数据可信
长期24月25℃-供试品溶液-2023120621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%
5min1252204-25220461.07759.462.1761.0859.462.17
2240595-24059558.26658.27
3237835-23783557.59757.60
4247133-24713359.84959.85
5248615-24861560.20860.21
6246704-24670459.74559.75
10min1264987-26498764.17365.431.4564.3165.561.44
2265673-26567364.33964.47
3271783-27178365.81965.95
4273471-27347166.22866.36
5271188-27118865.67565.81
6273954-27395466.34466.48
15min1281014-28101468.05468.931.1568.3369.211.15
2285296-28529669.09169.36
3282079-28207968.31268.59
4282811-28281168.48968.77
5287023-28702369.50969.79
6289540-28954070.11970.40
20min1290153-29015370.26771.302.3070.7071.732.29
2299282-29928272.47872.90
3301851-30185173.10073.53
4283384-28338468.62869.06
5294210-29421071.25071.68
6297540-29754072.05672.49
30min1309719-30971975.00675.751.2275.5976.341.20
2317363-31736376.85777.44
3314923-31492376.26676.85
4314796-31479676.23576.82
5312819-31281975.75776.35
6307052-30705274.36074.96
45min1319473-31947377.36879.571.5578.1280.321.54
2326264-32626479.01379.77
3330255-33025579.97980.74
4330281-33028179.98580.74
5333875-33387580.85681.62
6331182-33118280.20480.96
60min1340821-34082182.53882.372.0383.4683.312.01
2334480-33448081.00281.94
3346306-34630683.86684.80
4345530-34553083.67884.61
5329242-32924279.73480.67
6344489-34448983.42684.37
90min1346249-34624983.85284.961.4184.9686.081.40
2352204-35220485.29586.41
3351826-35182685.20386.33
4353196-35319685.53586.65
5357558-35755886.59187.71
6343958-34395883.29884.42
120min1349538-34953884.64984.371.3885.9485.681.35
2355745-35574586.15287.46
3343182-34318283.11084.42
4347499-34749984.15585.46
5350994-35099485.00286.31
6343453-34345383.17584.49
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1365606-36560688.54088.241.5090.0289.731.48
2370145-37014589.63991.13
3371316-37131689.92391.42
4360292-36029287.25388.75
5359096-35909686.96488.46
6359754-35975487.12388.62
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.213815013808683810153814603813433812370.08
212.133802733805663804200.06
单位质量响应值RSD%判断
31223.3431361.910.32数据可信
长期24月30℃-供试品溶液-2023120621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%
5min1237325-23732557.48557.682.4957.4957.692.49
2238810-23881057.84557.85
3241103-24110358.40158.40
4228293-22829355.29855.30
5237029-23702957.41457.41
6246325-24632559.66559.67
10min1262827-26282763.66364.591.9663.7964.721.95
2275536-27553666.74166.87
3265604-26560464.33564.47
4262620-26262063.61263.74
5263228-26322863.76063.89
6270226-27022665.45565.59
15min1278632-27863267.49168.361.8367.7668.641.83
2283595-28359568.69368.97
3290464-29046470.35770.63
4278361-27836167.42567.69
5277092-27709267.11867.39
6285237-28523769.09169.37
20min1288811-28881169.95671.351.4370.3871.771.43
2297211-29721171.99172.42
3298805-29880572.37772.81
4289834-28983470.20470.62
5295401-29540171.55371.97
6297292-29729272.01172.44
30min1306550-30655074.25375.270.9074.8375.850.90
2311163-31116375.37175.96
3311587-31158775.47376.06
4308813-30881374.80175.37
5311799-31179975.52576.10
6314625-31462576.20976.80
45min1314831-31483176.25978.791.7677.0079.541.75
2324891-32489178.69679.45
3324964-32496478.71479.47
4329022-32902279.69680.43
5326648-32664879.12179.87
6331436-33143680.28181.04
60min1325216-32521678.77581.692.0179.6882.622.00
2336029-33602981.39482.33
3337292-33729281.70082.63
4340464-34046482.46883.38
5339016-33901682.11783.04
6345605-34560583.71384.65
90min1336586-33658681.52984.551.9682.6185.661.95
2355128-35512886.02087.13
3347985-34798584.29085.40
4353568-35356885.64286.74
5347841-34784184.25585.36
6353242-35324285.56386.69
120min1342572-34257282.97987.322.8784.2488.622.84
2366099-36609988.67789.98
3373494-37349490.46991.77
4361910-36191087.66388.95
5357588-35758886.61687.91
6361329-36132987.52288.84
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1352143-35214385.29789.182.3586.7590.672.33
2376566-37656691.21392.71
3369113-36911389.40790.91
4366642-36664288.80990.29
5370418-37041889.72491.21
6374269-37426990.65692.17
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.213798843803543806123794593790843798790.17
212.133798903800663799780.04
单位质量响应值RSD%判断
31112.1231325.470.49数据可信
长期24月30℃-供试品溶液-2023120621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%
5min1240730-24073058.44858.040.6658.4558.040.66
2236608-23660857.44857.45
3237808-23780857.73957.74
4239176-23917658.07158.07
5239584-23958458.17058.17
6240357-24035758.35858.36
10min1265514-26551464.46665.041.3764.6065.161.37
2262172-26217263.65563.78
3269620-26962065.46365.59
4267794-26779465.02065.15
5269298-26929865.38565.51
6272777-27277766.22966.36
15min1280665-28066568.14568.331.1768.4268.601.17
2276011-27601167.01567.28
3280558-28055868.11968.39
4284316-28431669.03169.30
5285298-28529869.26969.54
6281811-28181168.42368.70
20min1288046-28804669.93771.301.3470.3671.731.34
2292020-29202070.90271.32
3293960-29396071.37371.80
4291917-29191770.87771.30
5297231-29723172.16772.60
6298869-29886972.56472.99
30min1308936-30893675.00975.620.5675.5976.200.56
2311981-31198175.74876.32
3310166-31016675.30775.89
4312941-31294175.98176.57
5311078-31107875.52976.12
6313589-31358976.13876.73
45min1329950-32995080.11179.900.7580.8680.650.74
2327657-32765779.55480.30
3326422-32642279.25480.01
4327041-32704179.40580.16
5330668-33066880.28581.04
6332753-33275380.79181.55
60min1338501-33850182.18783.401.5083.1184.331.49
2337323-33732381.90182.82
3341456-34145682.90483.83
4349608-34960884.88485.81
5348060-34806084.50885.44
6346130-34613084.03984.98
90min1344018-34401883.52685.101.5684.6386.211.55
2347109-34710984.27785.38
3349258-34925884.79985.91
4349250-34925084.79785.92
5353652-35365285.86686.99
6359585-35958587.30688.43
120min1359139-35913987.19887.531.5188.4988.831.50
2359115-35911587.19288.48
3352606-35260685.61286.91
4366900-36690089.08290.39
5366597-36659789.00990.32
6358591-35859187.06588.38
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1359549-35954987.29790.612.1388.7892.112.11
2371342-37134290.16191.64
3378784-37878491.96893.46
4370793-37079390.02791.53
5381899-38189992.72494.24
6376811-37681191.48993.00
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