托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
116.457985257982217978417986117983247983040.04
216.528008308023248015770.14
单位质量响应值RSD%判断
48529.1248521.610.02数据可信
供试品溶液-4D88SDA1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147799-477995.8986.222.855.906.222.83
250416-504166.2216.22
351412-514126.3446.34
451452-514526.3496.35
551376-513766.3406.34
649739-497396.1386.14
10min1102492-10249212.64713.021.6312.6613.031.62
2106638-10663813.15913.17
3106408-10640813.13113.14
4105743-10574313.04913.06
5107158-10715813.22313.23
6104648-10464812.91312.92
15min1147641-14764118.21918.771.5818.2518.801.58
2154027-15402719.00719.04
3152782-15278218.85318.89
4152903-15290318.86818.90
5153936-15393618.99619.03
6151409-15140918.68418.72
20min1186345-18634522.99523.541.6323.0623.601.63
2193472-19347223.87423.94
3190888-19088823.55523.62
4192142-19214223.71023.77
5193858-19385823.92223.99
6187646-18764623.15523.22
30min1245946-24594630.35030.971.2230.4531.081.22
2254090-25409031.35531.46
3250611-25061130.92531.03
4250421-25042130.90231.01
5254270-25427031.37731.48
6250641-25064130.92931.03
45min1306705-30670537.84738.861.4538.0039.011.44
2318979-31897939.36239.52
3313580-31358038.69638.85
4314374-31437438.79438.95
5318045-31804539.24739.40
6317583-31758339.19039.34
60min1352808-35280843.53644.631.4043.7544.851.40
2366571-36657145.23545.46
3360340-36034044.46644.68
4360541-36054144.49144.71
5365551-36555145.10945.33
6364223-36422344.94545.16
90min1409894-40989450.58152.001.6250.8752.301.62
2429179-42917952.96053.26
3417221-41722151.48551.78
4423030-42303052.20252.50
5424560-42456052.39052.69
6424437-42443752.37552.67
120min1453585-45358555.97256.721.0556.3457.101.05
2467416-46741657.67958.06
3456540-45654056.33756.72
4458052-45805256.52356.90
5460161-46016156.78457.17
6461914-46191457.00057.38
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1469596-46959657.94858.620.9058.4159.100.89
2476314-47631458.77759.26
3471987-47198758.24358.72
4474667-47466758.57459.05
5475737-47573758.70659.18
6482006-48200659.47959.95
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
116.457999967998478000417986797997167996560.08
216.528044958041618043280.03
单位质量响应值RSD%判断
48611.3148688.140.12数据可信
供试品溶液-4D88SDA1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147769-477695.8806.215.145.886.205.17
249025-490256.0346.03
355210-552106.7956.80
449573-495736.1026.10
551143-511436.2956.29
649791-497916.1286.13
10min199424-9942412.23812.883.4012.2512.893.39
2103985-10398512.79912.81
3110516-11051613.60313.61
4104254-10425412.83212.84
5105469-10546912.98212.99
6104192-10419212.82412.83
15min1143168-14316817.62218.492.8017.6518.522.80
2150000-15000018.46318.49
3156320-15632019.24019.27
4150800-15080018.56118.59
5151214-15121418.61218.64
6149924-14992418.45318.48
20min1182329-18232922.44223.252.1722.5023.312.17
2188456-18845623.19623.26
3194535-19453523.94424.01
4187596-18759623.09023.15
5191461-19146123.56623.63
6189045-18904523.26823.33
30min1239308-23930829.45530.421.6929.5530.521.69
2247035-24703530.40630.51
3246678-24667830.36230.47
4249106-24910630.66130.76
5251032-25103230.89831.00
6249518-24951830.71230.81
45min1301691-30169137.13338.401.7137.2838.551.71
2311638-31163838.35838.51
3313366-31336638.57038.73
4313162-31316238.54538.70
5316557-31655738.96339.12
6315255-31525538.80338.96
60min1346948-34694842.70444.121.6542.9144.341.65
2358456-35845644.12044.34
3362400-36240044.60644.83
4360815-36081544.41144.63
5362840-36284044.66044.88
6359175-35917544.20944.43
90min1409044-40904450.34751.511.2750.6351.801.27
2418684-41868451.53351.82
3419834-41983451.67551.97
4416894-41689451.31351.60
5423832-42383252.16752.46
6422760-42276052.03552.33
120min1449360-44936055.30956.160.9555.6756.540.95
2456238-45623856.15656.53
3458976-45897656.49356.87
4453301-45330155.79456.17
5458716-45871656.46156.84
6461085-46108556.75257.13
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1464618-46461857.18758.170.9657.6458.640.97
2473032-47303258.22358.69
3477578-47757858.78259.26
4476012-47601258.58959.06
5471297-47129758.00958.48
6473072-47307258.22858.70
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
116.458019828019918009178017948017118016790.06
216.528082108072388077240.09
单位质量响应值RSD%判断
48734.2948893.700.24数据可信
供试品溶液-3G80SDA2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150440-504406.1876.404.266.196.404.22
256367-563676.9156.91
350937-509376.2486.25
452082-520826.3896.39
550637-506376.2126.21
652359-523596.4236.42
10min1104470-10447012.81513.222.4512.8313.232.45
2112485-11248513.79913.81
3107998-10799813.24813.26
4107671-10767113.20813.22
5107443-10744313.18013.19
6106552-10655213.07113.08
15min1153829-15382918.87019.041.6518.9019.071.64
2159290-15929019.54019.57
3157460-15746019.31619.35
4153863-15386318.87418.91
5152975-15297518.76518.80
6153701-15370118.85518.89
20min1192428-19242823.60523.771.4523.6723.841.46
2198103-19810324.30124.37
3196158-19615824.06324.13
4190580-19058023.37823.44
5193260-19326023.70723.77
6192176-19217623.57423.64
30min1251562-25156230.85931.131.2930.9631.241.29
2257946-25794631.64231.75
3257748-25774831.61831.72
4250920-25092030.78030.88
5253430-25343031.08831.19
6251111-25111130.80430.91
45min1312479-31247938.33239.061.4138.4939.221.42
2323021-32302139.62539.79
3324359-32435939.78939.95
4315808-31580838.74038.89
5317260-31726038.91839.07
6317509-31750938.94939.10
60min1362604-36260444.48144.700.9444.7044.920.94
2367608-36760845.09445.32
3369561-36956145.33445.56
4361263-36126344.31644.54
5361718-36171844.37244.59
6363768-36376844.62344.84
90min1421519-42151951.70852.051.1252.0052.341.13
2426648-42664852.33752.64
3432957-43295753.11153.41
4421078-42107851.65451.95
5421056-42105651.65151.94
6422353-42235351.81052.10
120min1459222-45922256.33356.531.1856.7156.911.18
2462625-46262556.75057.14
3469729-46972957.62258.01
4454017-45401755.69456.07
5462126-46212656.68957.07
6457205-45720556.08556.47
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1483538-48353859.31658.191.7959.7958.671.78
2474565-47456558.21558.70
3483837-48383759.35259.84
4471400-47140057.82758.30
5461395-46139556.59957.07
6471562-47156257.84758.32
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
116.458053148048938053588055228053138052800.03
216.528089708077058083380.12
单位质量响应值RSD%判断
48953.1948930.870.04数据可信
供试品溶液-3G80SDA2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151844-518446.3436.224.486.346.224.49
250297-502976.1546.15
354027-540276.6106.61
449913-499136.1076.11
551711-517116.3276.33
647264-472645.7835.78
10min1105376-10537612.89312.803.6812.9012.803.68
2103955-10395512.71912.73
3108318-10831813.25313.26
4105043-10504312.85212.86
5107400-10740013.14013.15
697447-9744711.92311.93
15min1149934-14993418.34418.342.5818.3818.372.58
2148048-14804818.11318.14
3154712-15471218.92918.96
4150264-15026418.38518.42
5152709-15270918.68418.72
6143591-14359117.56817.60
20min1186144-18614422.77522.902.6722.8422.962.67
2184127-18412722.52822.59
3193255-19325523.64523.71
4188302-18830223.03923.10
5191410-19141023.41923.48
6179578-17957821.97122.03
30min1242561-24256129.67729.942.3029.7830.042.30
2240739-24073929.45429.55
3251449-25144930.76430.87
4246081-24608130.10830.21
5250300-25030030.62430.73
6237076-23707629.00629.10
45min1302270-30227036.98237.512.1637.1337.662.17
2303475-30347537.13037.28
3311513-31151338.11338.27
4310042-31004237.93338.08
5314860-31486038.52338.68
6297321-29732136.37736.52
60min1346291-34629142.36843.122.3542.5843.342.35
2348199-34819942.60242.81
3362417-36241744.34144.56
4354682-35468243.39543.61
5361090-36109044.17944.40
6342073-34207341.85242.06
90min1405710-40571049.63850.101.6149.9250.391.62
2407632-40763249.87350.15
3415323-41532350.81451.11
4408719-40871950.00650.29
5418936-41893651.25651.55
6400829-40082949.04149.32
120min1440861-44086153.93954.722.3454.3055.092.33
2444131-44413154.33954.70
3460285-46028556.31556.69
4446723-44672354.65655.03
5458316-45831656.07456.45
6433105-43310552.99053.35
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1456564-45656455.86056.502.2856.3256.962.28
2454773-45477355.64156.10
3471596-47159657.69958.17
4464858-46485856.87557.34
5474988-47498858.11458.58
6447803-44780354.78855.23
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