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%
114.894698724703534701744697784702384700830.06
214.944731364729574730460.03
单位质量响应值RSD%判断
31570.3831663.050.21数据可信
加速6月-供试品溶液-2024123021批-pH1.2(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%
5min1257002-25700248.57751.907.4948.5851.907.49
2276284-27628452.22252.22
3276621-27662152.28552.29
4246383-24638346.57046.57
5303288-30328857.32657.33
6287876-28787654.41354.41
10min1369910-36991069.91871.222.3070.0071.312.31
2370381-37038170.00770.09
3380411-38041171.90371.99
4367461-36746169.45569.53
5387623-38762373.26673.36
6385069-38506972.78472.87
15min1407798-40779877.08077.701.3577.2877.901.36
2405579-40557976.66076.86
3411365-41136577.75477.96
4406359-40635976.80877.00
5416212-41621278.67078.89
6419007-41900779.19879.41
20min1427606-42760680.82480.941.0881.1581.271.09
2421241-42124179.62179.95
3428183-42818380.93381.27
4425864-42586480.49480.82
5431860-43186081.62881.98
6434410-43441082.11082.45
30min1446187-44618784.33684.401.0884.8084.881.08
2439352-43935283.04483.51
3446977-44697784.48584.96
4444295-44429583.97884.43
5448592-44859284.79085.28
6453899-45389985.79386.27
45min1459178-45917886.79186.920.9887.3987.530.98
2452724-45272485.57186.17
3462371-46237187.39588.01
4458917-45891786.74287.34
5459620-45962086.87587.50
6466251-46625188.12888.75
60min1468818-46881888.61388.280.7889.3689.030.78
2460721-46072187.08387.83
3468925-46892588.63489.39
4466647-46664788.20388.94
5465952-46595288.07288.84
6471186-47118689.06189.83
极限1474681-47468189.72289.790.7590.6290.690.76
2469458-46945888.73489.62
3478569-47856990.45691.36
4474247-47424789.63990.53
5473947-47394789.58390.50
6479260-47926090.58791.51
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%
114.894685824694424699874704064700324696900.16
214.944717814716294717050.03
单位质量响应值RSD%判断
31543.9931573.290.07数据可信
加速6月-供试品溶液-2024123021批-pH1.2(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%
5min1267414-26741450.63846.626.3050.6446.626.30
2248296-24829647.01847.02
3244911-24491146.37746.38
4229095-22909543.38243.38
5228935-22893543.35243.35
6258554-25855448.96048.96
10min1369575-36957569.98368.091.8270.0768.171.83
2361494-36149468.45368.53
3354707-35470767.16867.25
4353889-35388967.01367.09
5353681-35368166.97467.05
6364005-36400568.92969.01
15min1401421-40142176.01474.831.0976.2175.021.09
2398794-39879475.51675.71
3392760-39276074.37474.56
4389713-38971373.79773.98
5393198-39319874.45774.64
6395056-39505674.80975.00
20min1417369-41736979.03478.130.8679.3678.450.87
2416383-41638378.84779.17
3411201-41120177.86678.18
4408195-40819577.29777.60
5411704-41170477.96178.27
6410791-41079177.78878.11
30min1436308-43630882.62081.900.9383.0882.340.94
2438196-43819682.97883.43
3431637-43163781.73682.18
4427550-42755080.96281.40
5431334-43133481.67882.12
6429875-42987581.40281.85
45min1449073-44907385.03785.051.0585.6385.631.05
2456276-45627686.40186.99
3451016-45101685.40585.98
4442169-44216983.73084.30
5446511-44651184.55285.13
6449814-44981485.17885.76
60min1455087-45508786.17686.210.9586.9186.930.95
2461767-46176787.44188.17
3458829-45882986.88587.61
4450322-45032285.27485.98
5453182-45318285.81586.53
6452417-45241785.67186.40
极限1462137-46213787.51187.641.1088.3988.511.10
2470778-47077889.14790.03
3466909-46690988.41589.28
4457513-45751386.63587.49
5458807-45880786.88187.74
6460740-46074087.24788.12
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%
114.894715164719354720774722774722354720080.07
214.944777264776554776900.02
单位质量响应值RSD%判断
31699.6631973.900.61数据可信
加速6月-供试品溶液-JPS7664批-pH1.2(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%
5min1281858-28185852.90853.203.5252.9153.203.52
2289009-28900954.25054.25
3276707-27670751.94151.94
4288177-28817754.09454.09
5296458-29645855.64855.65
6268434-26843450.38850.39
10min1358478-35847867.29069.313.5667.3869.403.56
2384403-38440372.15772.25
3359746-35974667.52867.61
4370111-37011169.47469.56
5385852-38585272.42972.52
6356969-35696967.00767.09
15min1387687-38768772.77374.993.4072.9775.193.40
2415557-41555778.00578.22
3390147-39014773.23573.43
4399776-39977675.04275.25
5416414-41641478.16578.38
6387335-38733572.70772.90
20min1404740-40474075.97478.033.2576.3078.363.25
2431272-43127280.95481.30
3405748-40574876.16376.48
4415006-41500677.90178.23
5433355-43335581.34581.69
6404071-40407175.84976.17
30min1420421-42042178.91881.493.4179.3781.943.41
2451677-45167784.78585.26
3425157-42515779.80780.25
4432968-43296881.27381.73
5452956-45295685.02585.50
6421483-42148379.11779.56
45min1434731-43473181.60484.293.2682.1884.893.27
2466948-46694887.65188.27
3440093-44009382.61083.19
4447970-44797084.08984.69
5467181-46718187.69588.32
6437480-43748082.12082.69
60min1440935-44093582.76885.403.5083.4886.133.50
2474961-47496189.15589.92
3445000-44500083.53184.25
4452443-45244384.92885.66
5474611-47461189.09089.86
6441687-44168782.90983.62
极限1441087-44108782.79785.933.8483.6586.813.84
2478578-47857889.83490.75
3446943-44694383.89684.75
4454593-45459385.33286.21
5480837-48083790.25891.17
6444713-44471383.47784.33
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%
114.894728954732974732604736904737064733700.08
214.944726274722514724390.06
单位质量响应值RSD%判断
31791.1331622.420.38数据可信
加速6月-供试品溶液-JPS7664批-pH1.2(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%
5min1275547-27554751.93552.352.9751.9352.352.97
2287880-28788054.25954.26
3288454-28845454.36754.37
4272128-27212851.29051.29
5271940-27194051.25551.25
6270616-27061651.00551.01
10min1355882-35588267.07668.712.6867.1668.802.68
2378900-37890071.41471.50
3373304-37330470.36070.45
4361260-36126068.09068.18
5363656-36365668.54168.63
6354242-35424266.76766.85
15min1386379-38637972.82474.202.6073.0274.402.60
2410238-41023877.32177.53
3401991-40199175.76775.97
4388539-38853973.23173.43
5390658-39065873.63173.83
6384197-38419772.41372.61
20min1399926-39992675.37777.242.7475.7077.572.74
2428104-42810480.68881.03
3417162-41716278.62678.96
4405446-40544676.41876.74
5409374-40937477.15877.48
6398838-39883875.17275.49
30min1415707-41570778.35280.602.9778.8081.052.97
2448229-44822984.48184.95
3436761-43676182.32082.79
4423815-42381579.88080.33
5425190-42519080.13980.59
6416008-41600878.40978.85
45min1429713-42971380.99283.392.9981.5783.972.99
2462957-46295787.25787.87
3452895-45289585.36185.96
4438413-43841382.63183.21
5440864-44086483.09383.68
6429639-42963980.97881.55
60min1435745-43574582.12984.373.0882.8485.103.07
2468890-46889088.37689.13
3459552-45955286.61687.36
4440593-44059383.04283.76
5446113-44611384.08384.81
6435064-43506482.00082.71
极限1438465-43846582.64184.823.1383.4985.693.13
2473600-47360089.26390.17
3459640-45964086.63287.52
4444512-44451283.78184.64
5446789-44678984.21085.07
6437127-43712782.38983.23
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