利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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%
110.203217893221553219433219573220703219830.05
210.353229403232803231100.08
单位质量响应值RSD%判断
31566.9631218.360.79数据可信
供试品溶液-2023072811批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107367-10736730.65930.195.0030.6630.195.00
2109243-10924331.19531.19
3111249-11124931.76831.77
497003-9700327.70027.70
5101901-10190129.09829.10
6107519-10751930.70230.70
10min1153872-15387243.93943.661.3844.0143.721.38
2155746-15574644.47444.54
3154239-15423944.04344.11
4151710-15171043.32143.38
5149957-14995742.82142.89
6151786-15178643.34343.41
15min1176879-17687950.50850.161.5550.6750.331.55
2179317-17931751.20551.37
3177124-17712450.57850.75
4175660-17566050.16050.32
5172561-17256149.27549.44
6172446-17244649.24349.41
20min1191775-19177554.76254.481.4055.0454.761.40
2193622-19362255.28955.57
3192019-19201954.83255.11
4191966-19196654.81755.09
5189157-18915754.01454.28
6186231-18623153.17953.45
30min1210487-21048760.10559.721.3660.5060.111.36
2212131-21213160.57560.98
3210308-21030860.05460.46
4209978-20997859.96060.35
5207718-20771859.31559.70
6204129-20412958.29058.68
45min1226380-22638064.64464.151.0565.1864.681.05
2226875-22687564.78565.32
3225542-22554264.40464.94
4225225-22522564.31464.84
5223437-22343763.80364.32
6220532-22053262.97463.50
60min1235667-23566767.29566.741.0067.9767.411.01
2235739-23573967.31668.00
3234802-23480267.04867.73
4234210-23421066.87967.55
5232086-23208666.27366.94
6229806-22980665.62266.28
极限1245236-24523670.02869.361.2770.8570.181.27
2244579-24457969.84070.67
3244438-24443869.80070.63
4244261-24426169.75070.57
5241649-24164969.00469.81
6237123-23712367.71168.52
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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%
110.203215873214763213653212323215863214490.05
210.353217463215393216420.05
单位质量响应值RSD%判断
31514.6131076.520.99数据可信
供试品溶液-2023072811批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112935-11293532.35030.793.5732.3530.803.57
2108004-10800430.93730.94
3107165-10716530.69730.70
4101375-10137529.03829.04
5109478-10947831.35931.36
6106064-10606430.38130.38
10min1157983-15798345.25344.301.6645.3344.371.67
2154898-15489844.37044.44
3157404-15740445.08745.16
4152446-15244643.66743.73
5153269-15326943.90343.97
6151969-15196943.53143.60
15min1180919-18091951.82351.101.2452.0051.271.24
2178924-17892451.25251.42
3180955-18095551.83452.00
4176916-17691650.67750.84
5176710-17671050.61850.78
6175947-17594750.39950.56
20min1194836-19483655.81055.211.0856.1055.491.08
2193585-19358555.45155.73
3194998-19499855.85656.14
4191793-19179354.93855.21
5191307-19130754.79955.08
6189884-18988454.39154.67
30min1213054-21305461.02860.421.0561.4460.821.06
2211351-21135160.54060.94
3213733-21373361.22361.63
4210147-21014760.19560.59
5209156-20915659.91260.31
6208066-20806659.59960.00
45min1228090-22809065.33564.701.0165.8865.231.00
2225807-22580764.68165.22
3228874-22887465.56066.10
4225115-22511564.48365.01
5224317-22431764.25464.79
6222930-22293063.85764.39
60min1236788-23678867.82767.280.9968.5267.960.99
2235077-23507767.33668.02
3238169-23816968.22268.91
4233682-23368266.93767.61
5233653-23365366.92967.61
6231861-23186166.41567.09
极限1246515-24651570.61369.910.9471.4670.740.95
2243996-24399669.89170.72
3247026-24702670.75971.60
4243114-24311469.63970.46
5242695-24269569.51970.34
6241113-24111369.06569.88
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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%
110.203223563225213224393222213218493222770.09
210.353218263220343219300.05
单位质量响应值RSD%判断
31595.7831104.351.11数据可信
供试品溶液-2023072911批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118197-11819733.79828.9323.7533.8028.9323.75
2102128-10212829.20329.20
3113126-11312632.34832.35
4108299-10829930.96830.97
5111900-11190031.99832.00
653366-5336615.26015.26
10min1163148-16314846.65243.427.8646.7343.497.88
2151128-15112843.21543.28
3157045-15704544.90744.98
4155169-15516944.37144.44
5155759-15575944.53944.61
6128843-12884336.84336.88
15min1187342-18734253.57051.462.4853.7551.622.51
2176383-17638350.43750.60
3180494-18049451.61251.78
4179947-17994751.45651.62
5181188-18118851.81151.98
6174456-17445649.88650.00
20min1201392-20139257.58855.851.7857.8956.121.81
2193178-19317855.23955.51
3195090-19509055.78656.07
4195707-19570755.96256.24
5195463-19546355.89356.18
6191029-19102954.62554.85
30min1218526-21852662.48861.121.2962.9161.521.31
2213139-21313960.94761.34
3213295-21329560.99261.40
4213953-21395361.18061.59
5213627-21362761.08761.50
6210002-21000260.05060.40
45min1234818-23481867.14666.051.0867.7166.581.07
2228382-22838265.30665.84
3229105-22910565.51366.06
4229507-22950765.62866.17
5231027-23102766.06266.61
6232967-23296766.61767.10
60min1243213-24321369.54768.690.8770.2669.370.86
2238549-23854968.21368.89
3238694-23869468.25568.95
4238227-23822768.12168.81
5240539-24053968.78269.47
6242067-24206769.21969.85
极限1252356-25235672.16171.220.7773.0372.050.77
2247356-24735670.73171.56
3247492-24749270.77071.61
4247919-24791970.89271.73
5249482-24948271.33972.18
6249730-24973071.41072.19
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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%
110.203220283221213225533223933223303222850.07
210.353227953227513227730.01
单位质量响应值RSD%判断
31596.5731185.800.93数据可信
供试品溶液-2023072911批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106012-10601230.27431.185.1030.2731.185.09
2109005-10900531.12931.13
3108150-10815030.88430.88
4112697-11269732.18332.18
5101541-10154128.99729.00
6117704-11770433.61333.61
10min1128259-12825936.62743.367.9636.6943.437.96
2155571-15557144.42644.50
3155234-15523444.33044.40
4157095-15709544.86244.93
5152084-15208443.43143.50
6162812-16281246.49446.57
15min1173888-17388849.65751.342.4349.8151.502.44
2181566-18156651.85052.02
3179815-17981551.35051.52
4180128-18012851.43951.61
5176591-17659150.42950.59
6186627-18662753.29553.47
20min1189462-18946254.10555.661.9154.3655.931.92
2195424-19542455.80756.09
3195299-19529955.77256.05
4195237-19523755.75456.04
5193089-19308955.14055.41
6200856-20085657.35857.65
30min1209146-20914659.72660.931.4160.1161.331.42
2213201-21320160.88461.29
3214253-21425361.18461.59
4212614-21261460.71661.13
5212588-21258860.70961.10
6218368-21836862.35962.78
45min1232463-23246366.38465.850.9866.9066.390.98
2230838-23083865.92066.46
3229403-22940365.51166.05
4229158-22915865.44165.99
5227825-22782565.06065.59
6233834-23383466.77667.34
60min1241759-24175969.03968.570.9169.7069.250.91
2240540-24054068.69169.38
3238221-23822168.02968.72
4238177-23817768.01668.71
5238529-23852968.11768.79
6243421-24342169.51470.22
极限1249239-24923971.17570.980.7271.9971.820.73
2248976-24897671.10071.94
3247889-24788970.79071.63
4246930-24693070.51671.36
5246759-24675970.46771.29
6251551-25155171.83572.70
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