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%
114.894715694695254692244705344710054703710.21
214.944700404714804707600.22
单位质量响应值RSD%判断
31589.7231510.040.18数据可信
加速6月-供试品溶液-JPS7664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%
5min1386415-38641573.19372.612.8873.1972.612.88
2393026-39302674.44574.44
3374274-37427470.89370.89
4369958-36995870.07570.08
5398100-39810075.40675.41
6378163-37816371.63071.63
10min1452726-45272685.75386.022.6385.8786.142.63
2458984-45898486.93887.06
3464148-46414887.91688.03
4438876-43887683.13083.25
5468345-46834588.71188.84
6441801-44180183.68483.80
15min1477377-47737790.42290.752.2990.6991.012.29
2478790-47879090.69090.96
3486748-48674892.19792.46
4469278-46927888.88889.14
5495890-49589093.92994.20
6466517-46651788.36588.62
20min1488354-48835492.50192.622.2592.9293.042.25
2489937-48993792.80193.22
3499505-49950594.61495.03
4478882-47888290.70791.11
5502546-50254695.19095.62
6474741-47474189.92390.33
30min1492086-49208693.20894.502.6293.7895.072.62
2503239-50323995.32195.90
3507719-50771996.16996.75
4486868-48686892.22092.77
5518271-51827198.16898.76
6485183-48518391.90192.46
45min1498476-49847694.41995.542.0495.1496.262.05
2510763-51076396.74697.48
3511738-51173896.93197.67
4492946-49294693.37194.08
5517648-51764898.05098.80
6494754-49475493.71494.42
60min1496556-49655694.05595.542.2594.9496.432.25
2508527-50852796.32297.22
3508940-50894096.40197.30
4494523-49452393.67094.53
5523181-52318199.098100.01
6494690-49469093.70294.57
极限1501944-50194495.07695.851.7196.1196.891.71
2508584-50858496.33397.39
3513187-51318797.20598.26
4495835-49583593.91894.94
5517873-51787398.09399.17
6498756-49875694.47295.49
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%
114.894671884691174695744688454690514687550.20
214.944722994702184712580.32
单位质量响应值RSD%判断
31481.2031543.370.14数据可信
长期6月-供试品溶液-JPS7664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%
5min1399285-39928575.72173.561.9575.7273.561.94
2387439-38743973.47473.47
3383183-38318372.66772.67
4389321-38932173.83173.83
5377040-37704071.50271.50
6391233-39123374.19474.19
10min1476689-47668990.40087.771.8890.5387.891.88
2465208-46520888.22288.34
3455596-45559686.39986.52
4464646-46464688.11688.24
5451685-45168585.65885.78
6463002-46300287.80487.93
15min1500386-50038694.89392.072.3495.1792.342.33
2489499-48949992.82993.10
3476335-47633590.33290.60
4491305-49130593.17193.44
5468666-46866688.87889.14
6486721-48672192.30292.57
20min1508451-50845196.42393.791.9996.8694.221.99
2496987-49698794.24994.67
3487027-48702792.36092.78
4499005-49900594.63295.06
5480191-48019191.06491.47
6495860-49586094.03594.46
30min1518791-51879198.38495.542.3398.9896.122.33
2508164-50816496.36896.95
3496067-49606794.07494.64
4506601-50660196.07296.65
5484942-48494291.96592.53
6508188-50818896.37396.95
45min1519321-51932198.48496.162.1899.2496.902.18
2511945-51194597.08697.83
3497712-49771294.38695.11
4513483-51348397.37798.12
5489896-48989692.90493.62
6510097-51009796.73597.48
60min1525735-52573599.70196.372.67100.6297.272.66
2515098-51509897.68398.59
3493802-49380293.64594.53
4514595-51459597.58898.49
5490491-49049193.01793.89
6509296-50929696.58397.49
极限1529624-529624100.43896.572.82101.5397.632.81
2512906-51290697.26898.33
3499005-49900594.63295.67
4514601-51460197.58998.66
5487777-48777792.50293.53
6511360-51136096.97598.04
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%
114.894698534710074695494694284694514698580.15
214.944786654775734781190.17
单位质量响应值RSD%判断
31555.2732002.611.00数据可信
加速6月-供试品溶液-JPS7664批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1330288-33028862.11361.473.2162.1161.473.21
2341216-34121664.16964.17
3328893-32889361.85161.85
4319418-31941860.06960.07
5310851-31085158.45858.46
6330576-33057662.16862.17
10min1405358-40535876.23176.371.3576.3376.471.35
2415012-41501278.04678.15
3407784-40778476.68776.79
4403904-40390475.95876.06
5398283-39828374.90075.00
6406140-40614076.37876.48
15min1434091-43409181.63481.771.2081.8782.001.20
2441763-44176383.07783.31
3439050-43905082.56782.80
4433838-43383881.58781.81
5426843-42684380.27180.49
6433180-43318081.46381.69
20min1447429-44742984.14385.000.8384.5185.360.83
2457802-45780286.09486.47
3453819-45381985.34485.71
4452630-45263085.12185.48
5451362-45136284.88285.24
6448723-44872384.38684.75
30min1472235-47223588.80888.550.9489.3189.050.94
2476017-47601789.51990.04
3473315-47331589.01189.52
4468244-46824488.05788.56
5463501-46350187.16587.66
6471778-47177888.72289.23
45min1485900-48590091.37891.380.9692.0392.030.96
2494676-49467693.02893.70
3486137-48613791.42292.08
4484402-48440291.09691.75
5482452-48245290.72991.37
6481813-48181390.60991.26
60min1490998-49099892.33692.831.3693.1493.631.36
2503662-50366294.71895.54
3497911-49791193.63694.45
4490228-49022892.19192.99
5484354-48435491.08791.88
6494495-49449592.99493.80
极限1494896-49489693.06993.270.8394.0394.230.83
2502033-50203394.41295.39
3498584-49858493.76394.73
4493598-49359892.82593.78
5490194-49019492.18593.13
6496449-49644993.36194.32
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%
114.894713994705164694994706544700704704280.16
214.944706304676914691600.45
单位质量响应值RSD%判断
31593.5531402.950.43数据可信
长期6月-供试品溶液-JPS7664批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321677-32167761.03161.962.9961.0361.962.99
2324294-32429461.52761.53
3320136-32013660.73860.74
4319758-31975860.66760.67
5328175-32817562.26462.26
6345431-34543165.53765.54
10min1398648-39864875.63478.032.6375.7478.142.63
2404659-40465976.77576.88
3405036-40503676.84676.95
4411049-41104977.98778.09
5426207-42620780.86380.97
6422072-42207280.07880.19
15min1425358-42535880.70283.001.8880.9383.241.88
2433444-43344482.23682.47
3433773-43377382.29882.53
4443264-44326484.09984.33
5440835-44083583.63883.88
6448236-44823685.04285.28
20min1445665-44566584.55486.201.8784.9286.571.87
2446740-44674084.75885.13
3449004-44900485.18885.55
4459082-45908287.10087.47
5458639-45863987.01687.39
6466919-46691988.58788.97
30min1457715-45771586.84189.531.9387.3490.041.93
2469043-46904388.99089.50
3467308-46730888.66189.17
4477953-47795390.68091.20
5475881-47588190.28790.81
6483322-48332291.69992.23
45min1472590-47259089.66392.252.1490.3192.912.13
2480011-48001191.07191.73
3480595-48059591.18291.84
4499039-49903994.68195.35
5488171-48817192.61993.29
6496862-49686294.26894.95
60min1484879-48487991.99493.822.2392.7994.642.22
2486910-48691092.38093.19
3484988-48498892.01592.82
4509213-50921396.61197.44
5494426-49442693.80694.63
6506599-50659996.11596.96
极限1484783-48478391.97694.032.0392.9395.012.02
2486902-48690292.37893.34
3489571-48957192.88593.85
4506664-50666496.12897.11
5498144-49814494.51195.50
6507632-50763296.31197.31
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