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%
112.213858503860573859923858253851493857750.10
212.133857773852423855100.10
单位质量响应值RSD%判断
31595.0031781.530.42数据可信
长期24月25℃-供试品溶液-2023120521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%
5min1250013-25001359.80359.893.0159.8059.893.01
2242472-24247257.99958.00
3255474-25547461.10961.11
4240444-24044457.51457.51
5259079-25907961.97161.97
6254888-25488860.96960.97
10min1273016-27301665.30566.112.9065.4466.242.90
2272752-27275265.24265.37
3277408-27740866.35666.49
4264777-26477763.33463.46
5286593-28659368.55368.69
6283810-28381067.88768.02
15min1290428-29042869.47068.983.0769.7569.263.06
2278622-27862266.64666.92
3289429-28942969.23169.51
4277550-27755066.39066.66
5300100-30010071.78472.07
6294261-29426170.38770.67
20min1300740-30074071.93772.143.0972.3772.583.09
2296242-29624270.86171.28
3306025-30602573.20173.64
4286591-28659168.55268.97
5313044-31304474.88075.33
6306911-30691173.41373.86
30min1315438-31543875.45275.453.0976.0476.043.09
2310190-31019074.19774.78
3317612-31761275.97276.57
4299384-29938471.61272.18
5323911-32391177.47978.10
6326061-32606177.99378.60
45min1335983-33598380.36779.433.7181.1380.193.70
2323664-32366477.42078.16
3335816-33581680.32781.10
4311408-31140874.48875.22
5342111-34211181.83382.62
6343408-34340882.14382.92
60min1345150-34515082.56081.664.4583.5082.604.44
2330634-33063479.08780.00
3349309-34930983.55484.50
4315808-31580875.54176.43
5352575-35257584.33685.31
6354863-35486384.88385.84
90min1373269-37326989.28684.874.6490.4185.994.56
2361020-36102086.35687.45
3327335-32733578.29879.43
4367786-36778687.97489.04
5349264-34926483.54484.70
6350175-35017583.76284.91
120min1378942-37894290.64386.634.8191.9687.944.72
2375278-37527889.76691.05
3331997-33199779.41380.72
4371827-37182788.94190.20
5354956-35495684.90586.25
6360078-36007886.13087.47
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1389081-38908193.06889.234.0094.5990.733.94
2381018-38101891.13992.62
3347101-34710183.02684.51
4382182-38218291.41892.87
5371429-37142988.84590.38
6367416-36741687.88689.41
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%
112.213850863853593848873850283840633848850.13
212.133854333851823853080.05
单位质量响应值RSD%判断
31522.1131764.880.55数据可信
长期24月25℃-供试品溶液-2023120521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%
5min1230760-23076055.27658.724.1755.2858.724.17
2238798-23879857.20157.20
3240786-24078657.67857.68
4258160-25816061.83961.84
5248685-24868559.57059.57
6253754-25375460.78460.78
10min1282247-28224767.60965.823.0167.7365.953.01
2263212-26321263.05063.18
3270801-27080164.86765.00
4285846-28584668.47168.61
5271174-27117464.95765.09
6275367-27536765.96166.10
15min1292667-29266770.10568.613.4370.3868.893.42
2276655-27665566.27066.54
3273441-27344165.50065.77
4299457-29945771.73272.02
5289059-28905969.24169.52
6287381-28738168.83969.12
20min1306589-30658973.44071.743.4273.8772.173.42
2284206-28420668.07868.49
3292348-29234870.02970.45
4312691-31269174.90275.35
5298130-29813071.41471.84
6302954-30295472.56973.00
30min1322757-32275777.31374.913.3077.9075.503.29
2307544-30754473.66974.23
3295421-29542170.76571.34
4315850-31585075.65876.27
5322487-32248777.24877.84
6312257-31225774.79875.39
45min1310109-31010974.28378.963.6675.0579.723.63
2320470-32047076.76577.49
3338866-33886681.17281.90
4332565-33256579.66280.45
5334063-33406380.02180.78
6341846-34184681.88582.65
60min1314438-31443875.32081.194.3376.2582.124.29
2327962-32796278.56079.46
3349826-34982683.79784.71
4343104-34310482.18783.15
5347137-34713783.15384.09
6351209-35120984.12885.07
90min1354362-35436284.88384.111.2885.9885.221.28
2342626-34262682.07283.15
3352825-35282584.51585.61
4350880-35088084.04985.19
5351003-35100384.07985.20
6354994-35499485.03586.17
120min1352800-35280084.50986.214.8885.7987.504.79
2372960-37296089.33890.60
3370334-37033488.70989.99
4357124-35712485.54586.88
5376589-37658990.20891.52
6329524-32952478.93480.25
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1369352-36935288.47489.004.0189.9590.493.94
2379628-37962890.93692.39
3381046-38104691.27592.76
4367231-36723187.96689.49
5386811-38681192.65694.17
6345145-34514582.67684.17
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%
112.213854313850763852343845063853923851280.10
212.133836913841833839370.10
单位质量响应值RSD%判断
31542.0131651.850.25数据可信
长期24月30℃-供试品溶液-2023120521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%
5min1238432-23843257.19756.680.8857.2056.680.87
2235148-23514856.40956.41
3237403-23740356.95056.95
4235841-23584156.57656.58
5232923-23292355.87655.88
6237864-23786457.06157.06
10min1260393-26039362.46563.532.0462.5963.652.04
2272215-27221565.30165.43
3270272-27027264.83564.96
4258613-25861362.03862.16
5264362-26436263.41863.54
6263052-26305263.10363.23
15min1273871-27387165.69966.992.3265.9667.262.31
2278791-27879166.87967.15
3289248-28924869.38769.66
4282735-28273567.82568.09
5279810-27981067.12367.39
6271071-27107165.02765.29
20min1289821-28982169.52570.401.6869.9470.811.67
2291477-29147769.92270.34
3294537-29453770.65671.08
4287668-28766869.00869.42
5295783-29578370.95571.37
6301431-30143172.31072.72
30min1314643-31464375.47974.352.7976.0574.922.76
2304146-30414672.96173.54
3300866-30086672.17472.76
4304836-30483673.12773.69
5324322-32432277.80178.37
6310863-31086374.57375.14
45min1330968-33096879.39679.522.0680.1380.262.04
2331874-33187479.61380.35
3327957-32795778.67379.42
4327983-32798378.68079.41
5344595-34459582.66583.41
6325595-32559578.10778.84
60min1340485-34048581.67981.372.0582.5982.282.03
2331727-33172779.57880.49
3342357-34235782.12883.04
4331933-33193379.62780.53
5350118-35011883.98984.92
6338466-33846681.19482.11
90min1350762-35076284.14484.201.6585.2485.291.65
2351482-35148284.31785.41
3347719-34771983.41484.51
4345083-34508382.78283.86
5361840-36184086.80187.92
6348969-34896983.71484.81
120min1350296-35029684.03284.591.8485.3185.871.83
2349015-34901583.72585.00
3348322-34832283.55984.84
4349241-34924183.77985.05
5365277-36527787.62688.93
6353588-35358884.82286.10
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1367792-36779288.22987.650.4989.7089.120.47
2364889-36488987.53389.00
3366213-36621387.85189.32
4366262-36626287.86289.31
5362688-36268887.00588.51
6364383-36438387.41288.88
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%
112.213846223843193840903843533844573843680.06
212.133844463853293848880.17
单位质量响应值RSD%判断
31479.7731730.260.57数据可信
长期24月30℃-供试品溶液-2023120521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%
5min1236837-23683756.80157.221.7956.8057.221.79
2239421-23942157.42157.42
3233074-23307455.89855.90
4235427-23542756.46356.46
5243341-24334158.36158.36
6243468-24346858.39158.39
10min1263210-26321063.12663.452.5763.2563.582.57
2256960-25696061.62761.75
3268877-26887764.48564.61
4260938-26093862.58162.71
5275967-27596766.18566.32
6261493-26149362.71462.84
15min1280423-28042367.25467.551.9267.5267.821.92
2280500-28050067.27367.54
3275908-27590866.17166.44
4277743-27774366.61166.88
5290907-29090769.76870.05
6284483-28448368.22868.50
20min1290734-29073469.72770.431.2470.1470.841.24
2289999-28999969.55169.96
3291587-29158769.93270.35
4295920-29592070.97171.38
5299529-29952971.83672.27
6294140-29414070.54470.96
30min1300784-30078472.13774.131.8372.7174.701.83
2303593-30359372.81173.38
3310506-31050674.46975.04
4311762-31176274.77075.34
5315448-31544875.65476.25
6312395-31239574.92275.50
45min1329603-32960379.04978.590.8579.7879.320.84
2327489-32748978.54279.27
3323990-32399077.70378.44
4331898-33189879.59980.34
5325873-32587378.15478.91
6327188-32718878.47079.21
60min1338216-33821681.11580.172.4382.0281.092.39
2331983-33198379.62080.52
3343147-34314782.29783.21
4340890-34089081.75682.67
5321278-32127877.05277.99
6330272-33027279.20980.13
90min1348682-34868283.62583.420.9884.7184.510.96
2353413-35341384.75985.84
3349510-34951083.82384.91
4344526-34452682.62883.72
5345355-34535582.82783.93
6345512-34551282.86483.96
120min1352181-35218184.46484.621.2685.7485.901.24
2346130-34613083.01384.28
3358992-35899286.09787.37
4351667-35166784.34185.62
5356242-35624285.43886.73
6351780-35178084.36885.65
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1369618-36961888.64688.081.0190.1189.550.99
2368407-36840788.35589.81
3363297-36329787.13088.60
4364144-36414487.33388.80
5365233-36523387.59489.07
6372868-37286889.42590.89
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