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430060-202303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)10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%
110.153173833168033165803168633164703168200.12
210.193148223143533145880.11
单位质量响应值RSD%判断
31213.7930872.230.78数据可信
加速6月-供试品溶液-2024122521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%
5min1236871-23687168.40169.054.0468.4069.054.04
2244663-24466370.65170.65
3254500-25450073.49273.49
4226677-22667765.45765.46
5232981-23298167.27867.28
6239018-23901869.02169.02
10min1293971-29397184.89087.892.8585.0088.012.85
2316758-31675891.47091.59
3302461-30246187.34187.46
4312208-31220890.15690.27
5297392-29739285.87885.99
6303445-30344587.62687.74
15min1308133-30813388.97991.382.2489.2391.642.24
2326238-32623894.20894.48
3314529-31452990.82691.09
4323934-32393493.54293.80
5312313-31231390.18690.44
6313597-31359790.55790.82
20min1309116-30911689.26392.412.5189.6792.822.51
2331858-33185895.83096.26
3316876-31687691.50491.92
4326577-32657794.30594.72
5317760-31776091.75992.16
6317804-31780491.77292.18
30min1311043-31104389.82093.332.3290.3793.902.32
2330911-33091195.55796.14
3321485-32148592.83593.41
4331302-33130295.67096.24
5323246-32324693.34493.90
6321207-32120792.75593.32
45min1315018-31501890.96893.912.4791.6794.632.46
2335249-33524996.81097.56
3321809-32180992.92993.66
4334004-33400496.45097.18
5325084-32508493.87494.59
6319988-31998892.40393.12
60min1313699-31369990.58794.542.5791.4495.422.57
2336397-33639797.14198.05
3323699-32369993.47494.36
4335548-33554896.89697.79
5328999-32899995.00595.88
6325924-32592494.11794.99
极限1328442-32844294.84496.491.5295.8597.521.51
2338371-33837197.71198.78
3329300-32930095.09296.13
4337987-33798797.60098.65
5339597-33959798.06599.09
6331115-33111595.61696.65
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430060-202303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)10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%
110.153172903156733161253163243150133160850.27
210.193165233148663156940.38
单位质量响应值RSD%判断
31141.3830980.770.37数据可信
加速6月-供试品溶液-2024122621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%
5min1237666-23766668.58972.204.3268.5972.204.31
2261870-26187075.57475.57
3248435-24843571.69771.70
4257082-25708274.19274.19
5237315-23731568.48868.49
6258708-25870874.66274.66
10min1309626-30962689.35691.611.4489.4791.731.44
2323381-32338193.32693.45
3316864-31686491.44591.56
4317405-31740591.60191.73
5320151-32015192.39492.51
6317250-31725091.55791.68
15min1325793-32579394.02295.231.1294.2995.501.12
2333975-33397596.38396.66
3334650-33465096.57896.85
4326828-32682894.32194.60
5330231-33023195.30395.57
6328421-32842194.78195.06
20min1328009-32800994.66296.121.4095.0896.551.39
2335287-33528796.76297.20
3340059-34005998.13998.57
4328661-32866194.85095.28
5335265-33526596.75697.18
6331085-33108595.54995.98
30min1331762-33176295.74596.961.6396.3297.551.62
2336258-33625897.04297.65
3345563-34556399.728100.32
4330667-33066795.42996.02
5338187-33818797.59998.19
6333425-33342596.22596.82
45min1334886-33488696.64697.501.6197.3898.251.60
2338951-33895197.81998.58
3346532-346532100.007100.77
4330360-33036095.34096.09
5339740-33974098.04798.80
6336530-33653097.12197.88
60min1332948-33294896.08797.861.8596.9998.771.84
2339730-33973098.04498.97
3349283-349283100.801101.73
4332526-33252695.96596.87
5337898-33789897.51698.43
6342116-34211698.73399.65
极限1337233-33723397.32499.031.4898.38100.111.48
2343371-34337199.095100.19
3351735-351735101.509102.61
4338883-33888397.80098.87
5343763-34376399.208100.29
6343890-34389099.245100.33
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430060-202303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)10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%
110.153174923160103164813148833157403161210.31
210.193180213152803166500.62
单位质量响应值RSD%判断
31144.9331074.580.16数据可信
加速6月-供试品溶液-2024122721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%
5min1244105-24410570.33768.982.3070.3468.982.30
2232618-23261867.02767.03
3245646-24564670.78170.78
4240226-24022669.21969.22
5233018-23301867.14267.14
6240735-24073569.36669.37
10min1311972-31197289.89289.040.8390.0189.160.83
2305580-30558088.05088.16
3311189-31118989.66689.78
4310449-31044989.45389.57
5307777-30777788.68388.80
6307205-30720588.51988.63
15min1322350-32235092.88292.280.9793.1592.550.97
2315320-31532090.85791.12
3323703-32370393.27293.54
4319723-31972392.12592.39
5318359-31835991.73291.99
6322186-32218692.83593.10
20min1328383-32838394.62193.741.1795.0494.151.17
2319212-31921291.97892.39
3327990-32799094.50894.93
4324943-32494393.63094.05
5322717-32271792.98893.40
6328625-32862594.69195.11
30min1329882-32988295.05394.371.0595.6394.941.05
2321642-32164292.67893.24
3329482-32948294.93795.52
4325304-32530493.73494.31
5328097-32809794.53895.11
6330650-33065095.27495.85
45min1331832-33183295.61594.990.8496.3595.720.84
2325019-32501993.65194.37
3330852-33085295.33296.07
4328045-32804594.52395.25
5329858-32985895.04695.77
6332467-33246795.79896.53
60min1333556-33355696.11195.420.9797.0196.310.97
2326233-32623394.00194.88
3333822-33382296.18897.09
4328871-32887194.76195.65
5330372-33037295.19496.08
6334010-33401096.24297.14
极限1339761-33976197.89996.410.9598.9697.460.95
2332620-33262095.84296.87
3334048-33404896.25397.31
4333181-33318196.00397.05
5331087-33108795.40096.44
6336842-33684297.05898.11
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430060-202303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)10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%
110.153147043150373144583149893159913150360.19
210.193180223164733172480.35
单位质量响应值RSD%判断
31038.0331133.270.22数据可信
加速6月-供试品溶液-2024122521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%
5min1238618-23861868.80964.745.4868.8164.745.48
2224091-22409164.62064.62
3237214-23721468.40468.40
4215275-21527562.07862.08
5206903-20690359.66459.66
6224842-22484264.83764.84
10min1304603-30460387.83784.772.4687.9584.882.46
2292858-29285884.45084.56
3299734-29973486.43386.55
4285202-28520282.24282.35
5288044-28804483.06283.16
6293302-29330284.57884.69
15min1318385-31838591.81188.982.1492.0789.232.14
2309376-30937689.21389.46
3312873-31287390.22290.48
4300888-30088886.76687.01
5302159-30215987.13287.37
6307732-30773288.73988.99
20min1321125-32112592.60190.471.9693.0290.871.97
2313090-31309090.28490.68
3321440-32144092.69293.10
4309020-30902089.11189.50
5307334-30733488.62489.01
6310421-31042189.51589.91
30min1326065-32606594.02692.331.7894.5992.881.79
2321572-32157292.73093.28
3325997-32599794.00694.57
4312325-31232590.06490.60
5314702-31470290.74991.28
6320525-32052592.42892.97
45min1332780-33278095.96294.011.7896.6994.711.79
2328352-32835294.68595.39
3330545-33054595.31896.04
4321621-32162192.74493.43
5317248-31724891.48392.17
6325435-32543593.84494.54
60min1332021-33202195.74394.281.6596.6395.141.65
2331353-33135395.55196.41
3329879-32987995.12696.00
4325139-32513993.75994.60
5317743-31774391.62692.46
6325472-32547293.85594.71
极限1336503-33650397.03695.331.3498.0896.341.35
2333911-33391196.28897.31
3332683-33268395.93496.97
4326855-32685594.25495.25
5325282-32528293.80094.79
6328267-32826794.66195.67
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430060-202303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)10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%
110.153171303152493148863159523145223155480.33
210.193159333151063155200.19
单位质量响应值RSD%判断
31088.4730963.690.29数据可信
加速6月-供试品溶液-2024122621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%
5min1193778-19377855.98660.587.9755.9960.587.97
2222927-22292764.40864.41
3202536-20253658.51758.52
4188956-18895654.59354.59
5221661-22166164.04264.04
6228208-22820865.93465.93
10min1275376-27537679.56183.662.8979.6583.762.90
2291915-29191584.34084.45
3294019-29401984.94885.05
4284974-28497482.33582.43
5291569-29156984.24084.35
6299446-29944686.51686.63
15min1288759-28875983.42888.192.9283.6588.432.92
2306104-30610488.43988.69
3310537-31053789.72089.96
4303393-30339387.65687.88
5308545-30854589.14589.39
6314171-31417190.77091.02
20min1297029-29702985.81789.942.5486.1890.332.54
2312868-31286890.39490.79
3318198-31819891.93492.32
4308638-30863889.17289.55
5312862-31286290.39290.79
6318233-31823391.94492.35
30min1304023-30402387.83892.132.6388.3592.672.64
2318105-31810591.90792.45
3325718-32571894.10694.65
4315642-31564291.19591.72
5325680-32568094.09594.64
6324059-32405993.62794.19
45min1304395-30439587.94693.112.9188.6093.802.91
2322383-32238393.14393.84
3327213-32721394.53895.24
4321609-32160992.91993.59
5330240-33024095.41396.12
6327818-32781894.71395.43
60min1308122-30812289.02294.073.0589.8294.923.05
2325009-32500993.90194.76
3335626-33562696.96997.83
4322547-32254793.19094.02
5328440-32844094.89395.75
6333801-33380196.44297.31
极限1313865-31386590.68295.162.8991.6396.162.89
2329876-32987695.30896.32
3340577-34057798.39999.42
4323451-32345193.45194.44
5332823-33282396.15997.18
6335622-33562296.96898.00
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430060-202303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)10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%
110.153192703181693175893175193181403181370.23
210.193178533157083167800.48
单位质量响应值RSD%判断
31343.5531087.340.59数据可信
加速6月-供试品溶液-2024122721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%
5min1209366-20936660.12460.885.3160.1260.885.31
2212949-21294961.15361.15
3195904-19590456.25856.26
4219237-21923762.95862.96
5205839-20583959.11159.11
6228618-22861865.65265.65
10min1298250-29825085.64985.322.4285.7585.422.43
2302460-30246086.85886.96
3288244-28824482.77582.87
4298922-29892285.84285.95
5288810-28881082.93883.04
6305903-30590387.84687.96
15min1312759-31275989.81590.321.9390.0690.561.93
2319233-31923391.67491.92
3310310-31031089.11289.34
4310593-31059389.19389.44
5309604-30960488.90989.15
6324529-32452993.19593.45
20min1321086-32108692.20692.342.0692.6092.742.06
2327050-32705093.91994.32
3319369-31936991.71392.09
4317232-31723291.10091.50
5313236-31323689.95290.34
6331326-33132695.14795.56
30min1326035-32603593.62894.251.6094.1794.791.61
2329565-32956594.64195.20
3324638-32463893.22693.76
4326827-32682793.85594.40
5323935-32393593.02593.56
6338126-33812697.10097.67
45min1336242-33624296.55995.701.3097.2696.401.30
2334246-33424695.98696.70
3330115-33011594.79995.49
4328191-32819194.24794.95
5330939-33093995.03695.73
6339721-33972197.55898.29
60min1331383-33138395.16395.830.9096.0396.700.91
2334263-33426395.99096.86
3332375-33237595.44896.29
4330451-33045194.89695.76
5335103-33510396.23297.08
6338689-33868997.26198.16
极限1336152-33615296.53397.121.3697.5598.141.36
2342003-34200398.21399.25
3330851-33085195.01196.02
4339492-33949297.49298.51
5337084-33708496.80197.81
6343585-34358598.66799.72
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