利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.564675164671144667184657154664364667000.15
214.644652864658774655820.09
单位质量响应值RSD%判断
32053.5731802.050.56数据可信
长期3月-供试品溶液-2024122821批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1342979-34297964.19767.573.6764.2067.573.67
2377513-37751370.66170.66
3368095-36809568.89868.90
4347127-34712764.97464.97
5364826-36482668.28668.29
6365378-36537868.39068.39
10min1463116-46311686.68486.912.2286.7987.022.22
2481909-48190990.20190.32
3465603-46560387.14987.26
4452581-45258184.71284.82
5466829-46682987.37987.49
6455810-45581085.31685.43
15min1483239-48323990.45091.131.7990.7091.381.79
2502095-50209593.98094.25
3484605-48460590.70690.97
4483427-48342790.48690.73
5490783-49078391.86292.12
6476942-47694289.27289.53
20min1488287-48828791.39592.441.6391.8092.851.63
2508257-50825795.13395.56
3493436-49343692.35992.77
4492787-49278792.23792.64
5495384-49538492.72493.14
6484937-48493790.76891.17
30min1493952-49395292.45693.661.7093.0194.221.70
2514116-51411696.23096.81
3500969-50096993.76994.33
4502079-50207993.97794.53
5501933-50193393.94994.52
6489224-48922491.57192.13
45min1495559-49555992.75694.351.3093.4695.071.30
2514603-51460396.32197.06
3502674-50267494.08894.81
4506116-50611694.73295.44
5505986-50598694.70895.43
6499545-49954593.50294.21
60min1499432-49943293.48194.721.3594.3495.601.35
2518095-51809596.97597.88
3505440-50544094.60695.48
4508010-50801095.08795.96
5505551-50555194.62795.51
6499923-49992393.57394.44
极限1502558-50255894.06695.151.3395.0996.181.33
2517707-51770796.90297.97
3506117-50611794.73395.77
4515133-51513396.42097.45
5507516-50751694.99496.03
6500910-50091093.75894.78
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.564657624659334668214671734667994664980.14
214.644721294709704715500.18
单位质量响应值RSD%判断
32039.7032209.700.38数据可信
长期3月-供试品溶液-2024122921批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1362691-36269167.47067.654.2867.4767.654.28
2369064-36906468.65668.66
3362179-36217967.37567.37
4376832-37683270.10170.10
5334664-33466462.25662.26
6376454-37645470.03070.03
10min1468453-46845387.14587.320.7387.2687.430.73
2466154-46615486.71786.83
3472952-47295287.98288.09
4474086-47408688.19388.31
5468395-46839587.13487.24
6466206-46620686.72786.84
15min1477290-47729088.78990.601.1889.0590.861.18
2493047-49304791.72091.98
3486537-48653790.50990.77
4486892-48689290.57590.84
5492693-49269391.65491.90
6485708-48570890.35590.62
20min1485925-48592590.39591.761.1690.8092.171.16
2499333-49933392.88993.30
3491236-49123691.38391.79
4492967-49296791.70592.12
5500653-50065393.13593.54
6489560-48956091.07191.48
30min1493584-49358491.82092.721.3692.3893.291.35
2507959-50795994.49495.06
3491602-49160291.45192.01
4496880-49688092.43393.00
5505637-50563794.06294.62
6495000-49500092.08392.65
45min1497843-49784392.61293.401.2693.3294.111.25
2511633-51163395.17795.90
3499260-49926092.87693.59
4498254-49825492.68893.41
5508397-50839794.57595.29
6496934-49693492.44393.16
60min1499724-49972492.96293.701.1493.8394.571.14
2512891-51289195.41196.29
3501038-50103893.20694.08
4500851-50085193.17294.05
5508712-50871294.63495.51
6498812-49881292.79293.66
极限1509417-50941794.76595.201.1895.7896.231.18
2516142-51614296.01697.06
3503559-50355993.67594.70
4507362-50736294.38395.41
5519788-51978896.69497.72
6514290-51429095.67296.70
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.564666734683584664624662174662174667850.20
214.644686004692374689180.10
单位质量响应值RSD%判断
32059.4132029.920.07数据可信
长期3月-供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1389055-38905572.55567.914.9372.5567.924.92
2349921-34992165.25765.26
3363548-36354867.79867.80
4382451-38245171.32371.32
5354965-35496566.19766.20
6345099-34509964.35764.36
10min1480737-48073789.65386.712.5089.7786.822.50
2461098-46109885.99086.10
3468845-46884587.43587.55
4462867-46286786.32086.44
5470188-47018887.68587.80
6445863-44586383.14983.26
15min1495904-49590492.48190.771.3192.7591.021.31
2485470-48547090.53590.79
3488322-48832291.06791.33
4482501-48250189.98190.24
5490418-49041891.45891.71
6477716-47771689.08989.33
20min1499558-49955893.16292.190.8793.5992.590.88
2493752-49375292.08092.48
3497999-49799992.87293.28
4487537-48753790.92191.33
5494848-49484892.28492.69
6492231-49223191.79692.19
30min1503697-50369793.93493.530.9094.5194.090.89
2502274-50227493.66994.23
3503466-50346693.89194.46
4492493-49249391.84592.41
5504301-50430194.04794.61
6502926-50292693.79194.34
45min1508110-50811094.75794.141.0795.4994.861.06
2506744-50674494.50395.22
3508338-50833894.80095.52
4494128-49412892.15092.87
5505082-50508294.19394.91
6506509-50650994.45995.16
60min1508076-50807694.75194.661.0995.6595.541.08
2512402-51240295.55896.43
3509466-50946695.01095.89
4496794-49679492.64793.52
5509485-50948595.01495.89
6509397-50939794.99795.86
极限1514550-51455095.95895.461.1597.0196.501.13
2515193-51519396.07897.11
3509519-50951995.02096.06
4502607-50260793.73194.76
5510043-51004395.11896.15
6519496-51949696.88197.90
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