他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.581289681287751296731289741293291291440.28
212.581311341309231310280.12
单位质量响应值RSD%判断
10265.8210415.581.03数据可信
长期24月-供试品溶液-2022032501批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164223-6422349.65356.2913.9849.6556.2913.98
291548-9154870.78070.78
367418-6741852.12452.12
468422-6842252.90052.90
577342-7734259.79659.80
667907-6790752.50252.50
10min196623-9662374.70380.447.7574.8080.567.75
2106723-10672382.51282.65
398023-9802375.78675.89
4105015-10501581.19181.30
5118360-11836091.50991.63
699551-9955176.96777.07
15min1112634-11263487.08291.616.2987.3391.886.29
2116898-11689890.37990.69
3111073-11107385.87586.13
4117703-11770391.00191.27
5131902-131902101.979102.28
6120747-12074793.35493.61
20min1124948-12494896.60297.593.1197.0398.043.11
2123398-12339895.40495.89
3125703-12570397.18697.61
4125007-12500796.64897.10
5134058-134058103.646104.15
6124218-12421896.03896.48
30min1126912-12691298.12199.622.5298.74100.272.53
2128234-12823499.14399.82
3130166-130166100.637101.26
4128591-12859199.419100.06
5134353-134353103.874104.59
6124837-12483796.51797.15
45min1127127-12712798.287100.032.3899.10100.882.39
2130931-130931101.228102.10
3129835-129835100.381101.20
4130251-130251100.702101.54
5133469-133469103.190104.11
6124689-12468996.40297.23
极限1126395-12639597.72199.612.2298.73100.662.24
2130421-130421100.834101.91
3129714-129714100.287101.31
4129073-12907399.792100.84
5132693-132693102.590103.72
6124764-12476496.46097.48
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.581292651296091293151293011292251293430.12
212.581296511300331298420.21
单位质量响应值RSD%判断
10281.6410321.300.28数据可信
长期24月-供试品溶液-2022032501批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153862-5386241.79945.8512.8341.8045.8512.83
247880-4788037.15737.16
360329-6032946.81846.82
463029-6302948.91348.91
569904-6990454.24954.25
659451-5945146.13746.14
10min196242-9624274.68872.157.5574.7772.247.55
282548-8254864.06164.14
390478-9047870.21570.31
4103600-10360080.39980.50
594371-9437173.23673.34
690613-9061370.32070.41
15min1108182-10818283.95484.495.7384.1984.735.73
2101132-10113278.48378.69
3106291-10629182.48782.72
4119206-11920692.51092.77
5106058-10605882.30682.56
6112380-11238087.21287.45
20min1113471-11347188.05990.385.0188.4690.795.01
2110987-11098786.13186.49
3114942-11494289.20089.60
4124670-12467096.75097.19
5111896-11189686.83787.26
6122837-12283795.32795.73
30min1118090-11809091.64394.533.0592.2295.123.05
2121170-12117094.03494.57
3122909-12290995.38395.96
4127303-12730398.79399.43
5117468-11746891.16191.75
6123913-12391396.16296.76
45min1123945-12394596.18797.722.6496.9598.502.63
2126866-12686698.45499.17
3129432-129432100.445101.21
4129367-129367100.395101.23
5125063-12506397.05597.83
6120872-12087293.80294.59
极限1123662-12366295.96899.481.9796.92100.461.97
2126998-12699898.55699.47
3129137-129137100.216101.19
4129542-129542100.531101.57
5129165-129165100.238101.21
6130664-130664101.401102.38
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.581299781300991301651303981304751302230.16
212.581308611311191309900.14
单位质量响应值RSD%判断
10351.5910412.560.42数据可信
长期24月-供试品溶液-2022032501批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173402-7340256.52157.069.6756.5257.069.67
283827-8382764.54964.55
371965-7196555.41555.41
468600-6860052.82452.82
565488-6548850.42750.43
681338-8133862.63262.63
10min1104551-10455180.50784.306.3180.6284.416.32
2116372-11637289.60989.74
3112901-11290186.93787.05
4101584-10158478.22278.33
5104024-10402480.10180.20
6117410-11741090.40990.53
15min1120292-12029292.62895.495.7092.9095.785.70
2132647-132647102.142102.45
3128539-12853998.97899.26
4116052-11605289.36389.63
5117124-11712490.18990.45
6129434-12943499.66899.97
20min1126330-12633097.27799.734.2497.74100.204.24
2136656-136656105.229105.74
3135242-135242104.140104.62
4123085-12308594.77995.22
5125703-12570396.79597.24
6130056-130056100.147100.65
30min1128637-12863799.054101.272.8899.71101.952.89
2136953-136953105.457106.18
3135395-135395104.258104.95
4127620-12762098.27198.90
5130466-130466100.462101.10
6130043-130043100.137100.84
45min1128380-12838098.856101.663.0599.71102.543.05
2137531-137531105.902106.84
3136689-136689105.254106.15
4129124-12912499.429100.26
5130555-130555100.531101.37
6129850-12985099.988100.89
极限1128577-12857799.008101.252.87100.06102.332.88
2137058-137058105.538106.68
3135285-135285104.173105.28
4127913-12791398.49699.52
5130031-130031100.127101.16
6130066-130066100.154101.26
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.581321621323141321551322881324941322830.11
212.581320331323191321760.16
单位质量响应值RSD%判断
10515.3410506.840.06数据可信
长期24月-供试品溶液-2022032501批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173073-7307355.57749.0312.3755.5849.0312.37
260094-6009445.70645.71
372977-7297755.50455.50
462389-6238947.45147.45
565853-6585350.08650.09
652389-5238939.84539.85
10min1109694-10969483.43079.576.7483.5479.676.75
299731-9973175.85275.94
3110055-11005583.70483.82
495640-9564072.74172.84
5112738-11273885.74585.85
699862-9986275.95276.03
15min1125133-12513395.17290.964.5595.4591.224.55
2115742-11574288.03088.27
3121910-12191092.72193.00
4111783-11178385.01985.26
5125263-12526395.27195.54
6117721-11772189.53589.77
20min1127955-12795597.31995.523.0297.7995.963.03
2125679-12567995.58796.01
3127154-12715496.70997.17
4118900-11890090.43290.84
5129700-12970098.64699.11
6124150-12415094.42594.84
30min1133077-133077101.21498.202.33101.8898.832.34
2128224-12822497.52398.13
3128602-12860297.81198.47
4124954-12495495.03695.63
5132103-132103100.473101.13
6127701-12770197.12597.72
45min1134479-134479102.28098.832.34103.1599.662.36
2128197-12819797.50398.31
3129087-12908798.17999.03
4126276-12627696.04296.82
5132667-132667100.902101.76
6128950-12895098.07598.87
极限1134922-134922102.61799.562.09103.69100.582.11
2128954-12895498.07899.08
3130001-13000198.87599.92
4128322-12832297.59898.57
5133729-133729101.710102.77
6129483-12948398.48199.47
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