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%
1 15.174904264902194905304900004903124902970.05
2 15.124904994904394904690.01
单位质量响应值RSD%判断
32320.1732438.430.26数据可信
供试品溶液-2024122821批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1319336-31933658.93858.482.2158.9458.482.21
2323712-32371259.74559.75
3321160-32116059.27459.27
4315879-31587958.30058.30
5317436-31743658.58758.59
6303769-30376956.06556.06
10min1450970-45097083.23281.112.2883.3381.212.28
2442648-44264881.69681.80
3431840-43184079.70279.80
4449442-44944282.95083.05
5425688-42568878.56678.66
6436367-43636780.53780.63
15min1480660-48066088.71287.481.9588.9587.721.95
2477428-47742888.11688.35
3463375-46337585.52285.75
4485775-48577589.65689.89
5463138-46313885.47885.71
6473693-47369387.42687.65
20min1492270-49227090.85589.981.8291.2490.361.82
2491374-49137490.68991.07
3475695-47569587.79688.17
4499041-49904192.10492.49
5478606-47860688.33388.70
6488100-48810090.08590.46
30min1503783-50378392.98092.411.6793.5292.931.66
2505356-50535693.27093.80
3489458-48945890.33690.86
4512217-51221794.53695.07
5493279-49327991.04191.56
6499945-49994592.27192.79
45min1511254-51125494.35994.041.7295.0594.731.72
2513414-51341494.75795.45
3497814-49781491.87892.55
4522087-52208796.35897.05
5501382-50138292.53793.21
6511318-51131894.37095.05
60min1515092-51509295.06794.631.7295.9295.471.72
2516796-51679695.38196.23
3501095-50109592.48493.31
4526026-52602697.08597.94
5505623-50562393.31994.14
6511647-51164794.43195.27
极限1520098-52009895.99196.241.4597.0097.231.45
2525254-52525496.94297.95
3509764-50976494.08495.06
4532740-53274098.32499.34
5520367-52036796.04097.02
6520331-52033196.03497.03
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%
1 15.174904324904244902304902094896454901880.07
2 15.124899834901024900420.02
单位质量响应值RSD%判断
32312.9932410.190.22数据可信
供试品溶液-2024122921批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1300894-30089455.56461.066.5055.5661.066.50
2311366-31136657.49857.50
3344416-34441663.60163.60
4351970-35197064.99665.00
5325351-32535160.08160.08
6350074-35007464.64664.65
10min1443837-44383781.96183.371.4682.0583.461.47
2450767-45076783.24083.34
3447929-44792982.71682.82
4459616-45961684.87484.98
5447205-44720582.58382.68
6459306-45930684.81784.92
15min1475036-47503687.72288.761.3187.9589.001.31
2485998-48599889.74689.98
3473991-47399187.52987.77
4482467-48246789.09489.34
5476954-47695488.07688.31
6489407-48940790.37690.62
20min1488126-48812690.13991.051.3090.5191.441.30
2499666-49966692.27092.65
3485589-48558989.67190.06
4491980-49198090.85191.25
5491238-49123890.71491.10
6501717-50171792.64993.05
30min1500303-50030392.38893.161.2992.9193.701.29
2511588-51158894.47295.01
3495519-49551991.50492.04
4502153-50215392.72993.28
5505527-50552793.35393.89
6511936-51193694.53695.09
45min1507660-50766093.74694.481.4094.4395.181.40
2518503-51850395.74996.44
3500554-50055492.43493.13
4509871-50987194.15594.86
5513669-51366994.85695.55
6519583-51958395.94896.66
60min1508227-50822793.85195.061.3094.6995.911.30
2521674-52167496.33497.19
3505590-50559093.36494.21
4515105-51510595.12195.98
5516578-51657895.39396.24
6521394-52139496.28397.15
极限1514101-51410194.93695.780.9195.9396.800.91
2522598-52259896.50597.52
3512178-51217894.58195.58
4520032-52003296.03197.05
5519132-51913295.86596.87
6524143-52414396.79097.82
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%
1 15.174910604910914907654906604907334908620.05
2 15.124885924887104886510.02
单位质量响应值RSD%判断
32357.4232318.190.09数据可信
供试品溶液-2024123021批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1350761-35076164.82061.155.0564.8261.155.05
2326915-32691560.41460.41
3343483-34348363.47563.48
4309155-30915557.13257.13
5340448-34044862.91562.91
6314761-31476158.16858.17
10min1461344-46134485.25683.061.4285.3683.161.42
2445712-44571282.36782.47
3451332-45133283.40683.51
4445811-44581182.38682.48
5448662-44866282.91283.02
6444005-44400582.05282.15
15min1485795-48579589.77588.960.8590.0289.190.86
2475521-47552187.87688.11
3483442-48344289.34089.58
4482692-48269289.20189.43
5483664-48366489.38189.62
6477095-47709588.16788.40
20min1497656-49765691.96691.490.6292.3791.880.62
2492061-49206190.93391.32
3497753-49775391.98492.38
4497333-49733391.90792.29
5494790-49479091.43791.83
6490815-49081590.70291.08
30min1509264-50926494.11294.000.5094.6694.540.50
2506718-50671893.64194.18
3510942-51094294.42294.97
4511562-51156294.53695.07
5508345-50834593.94294.49
6504980-50498093.32093.85
45min1518467-51846795.81295.940.4096.5296.640.40
2516098-51609895.37596.07
3521815-52181596.43197.14
4520735-52073596.23196.92
5519674-51967496.03596.74
6518207-51820795.76496.45
60min1520893-52089396.26196.290.5197.1397.140.51
2520274-52027496.14697.00
3522741-52274196.60297.47
4525087-52508797.03697.89
5519777-51977796.05496.92
6517389-51738995.61396.46
极限1523614-52361496.76397.100.8697.7998.120.85
2533240-53324098.54299.55
3525299-52529997.07598.10
4527421-52742197.46798.48
5522834-52283496.61997.64
6520257-52025796.14397.15
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