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800
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%
112.044807774808814808884808234809024808540.02
212.064828154828004828080.01
单位质量响应值RSD%判断
39938.0440033.830.17数据可信
供试品溶液-2024010711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%
5min1140214-14021426.19422.3119.3726.1922.3119.38
298351-9835118.37418.37
3139726-13972626.10326.10
492682-9268217.31417.31
5104761-10476119.57119.57
6140798-14079826.30326.30
10min1195597-19559736.54135.036.0936.6035.086.10
2174542-17454232.60732.65
3197004-19700436.80336.86
4174455-17445532.59132.63
5183991-18399134.37234.42
6199521-19952137.27437.33
15min1223753-22375341.80142.012.9341.9442.142.92
2218063-21806340.73840.85
3224761-22476141.98942.13
4236232-23623244.13244.24
5219065-21906540.92541.04
6227339-22733942.47142.61
20min1240916-24091645.00745.383.0145.2445.602.99
2237210-23721044.31544.52
3242316-24231645.26845.50
4256517-25651747.92148.13
5236388-23638844.16144.37
6244078-24407845.59845.83
30min1259317-25931748.44549.122.5748.7849.442.55
2258515-25851548.29548.60
3260682-26068248.70049.03
4276238-27623851.60651.92
5259500-25950048.47948.79
6263372-26337249.20249.54
45min1272103-27210350.83351.572.6151.2752.002.60
2272066-27206650.82651.24
3273685-27368551.12951.57
4290274-29027454.22854.66
5271609-27160950.74151.16
6276629-27662951.67952.13
60min1280462-28046252.39552.822.4652.9553.372.45
2280494-28049452.40152.92
3282394-28239452.75653.31
4295479-29547955.20055.75
5274473-27447351.27651.81
6283245-28324552.91553.48
极限1287023-28702353.62053.670.4554.2954.330.46
2285869-28586953.40554.04
3287644-28764453.73654.41
4287033-28703353.62254.30
5286542-28654253.53154.17
6289561-28956154.09554.77
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800
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%
112.044801504803474801564802824801044802080.03
212.064794424794794794600.01
单位质量响应值RSD%判断
39884.3939756.220.23数据可信
供试品溶液-2024010711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%
5min1152475-15247528.60326.993.4928.6026.993.49
2140118-14011826.28526.29
3147533-14753327.67627.68
4140784-14078426.41026.41
5141798-14179826.60026.60
6140648-14064826.38526.38
10min1205771-20577138.60137.461.9438.6637.521.94
2198862-19886237.30537.36
3203016-20301638.08438.15
4196328-19632836.83036.89
5197687-19768737.08537.14
6196384-19638436.84036.90
15min1232472-23247243.61042.931.2743.7643.071.27
2228699-22869942.90243.04
3230794-23079443.29543.44
4226652-22665242.51842.66
5229947-22994743.13743.28
6224517-22451742.11842.26
20min1247621-24762146.45246.060.9546.7046.300.95
2246449-24644946.23246.47
3246903-24690346.31746.56
4244057-24405745.78346.02
5246663-24666346.27246.51
6241491-24149145.30245.54
30min1264875-26487549.68949.550.5350.0449.900.53
2264611-26461149.63949.98
3262821-26282149.30349.65
4264205-26420549.56349.90
5266083-26608349.91550.26
6262291-26229149.20449.54
45min1278268-27826852.20151.880.4552.6652.330.46
2276697-27669751.90652.36
3277639-27763952.08352.54
4275407-27540751.66452.11
5276052-27605251.78552.24
6275139-27513951.61452.06
60min1284457-28445753.36253.130.4753.9453.690.47
2283217-28321753.13053.69
3283742-28374253.22853.80
4282968-28296853.08353.64
5284102-28410253.29653.86
6280791-28079152.67453.23
极限1290849-29084954.56154.170.5055.2654.860.50
2288491-28849154.11954.80
3289401-28940154.29054.98
4288357-28835754.09454.77
5289096-28909654.23254.92
6286537-28653753.75254.43
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800
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%
112.044799034798204798154797904795264797710.03
212.064788064793374790720.08
单位质量响应值RSD%判断
39848.0939724.050.23数据可信
供试品溶液-2024010811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%
5min1147345-14734527.66528.695.0127.6628.695.02
2144522-14452227.13527.13
3146377-14637727.48327.48
4159024-15902429.85729.86
5157005-15700529.47829.48
6162624-16262430.53330.53
10min1205995-20599538.67739.252.1638.7439.322.17
2204999-20499938.49038.55
3204686-20468638.43138.49
4212460-21246039.89039.96
5210645-21064539.55039.62
6215562-21556240.47340.54
15min1236506-23650644.40544.551.0644.5544.701.08
2234096-23409643.95344.10
3235348-23534844.18844.33
4238755-23875544.82744.98
5237909-23790944.66944.82
6241099-24109945.26745.43
20min1257217-25721748.29447.760.7648.5448.010.75
2251953-25195347.30547.55
3254824-25482447.84448.09
4253747-25374747.64247.90
5252852-25285247.47447.73
6255582-25558247.98748.25
30min1274033-27403351.45151.020.5351.8051.380.52
2269705-26970550.63850.99
3272174-27217451.10251.45
4271093-27109350.89951.26
5271796-27179651.03151.39
6271660-27166051.00551.37
45min1285325-28532553.57153.150.5154.0453.620.51
2281666-28166652.88453.35
3283635-28363553.25453.72
4282355-28235553.01353.49
5281664-28166452.88453.36
6283764-28376453.27853.76
60min1290059-29005954.46054.110.4255.0554.700.42
2287281-28728153.93854.52
3288869-28886954.23654.82
4287759-28775954.02854.62
5286690-28669053.82754.42
6288443-28844354.15754.75
极限1292898-29289854.99354.900.2355.7055.610.23
2292638-29263854.94455.64
3292308-29230854.88255.59
4292447-29244754.90855.62
5291150-29115054.66555.37
6292983-29298355.00955.73
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800
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%
112.044802774800384800434797474800914800390.04
212.064789484789874789680.01
单位质量响应值RSD%判断
39870.3539715.420.28数据可信
供试品溶液-2024010811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%
5min1154968-15496829.09129.283.2929.0929.283.30
2163206-16320630.63730.64
3159185-15918529.88329.88
4154027-15402728.91428.91
5147979-14797927.77927.78
6156580-15658029.39429.39
10min1205737-20573738.62239.021.9338.6939.091.93
2213224-21322440.02740.10
3207973-20797339.04139.11
4206668-20666838.79638.86
5202149-20214937.94838.01
6211410-21141039.68639.75
15min1241414-24141445.31944.341.7145.4744.491.71
2234537-23453744.02844.18
3238001-23800144.67844.83
4234609-23460944.04144.19
5229942-22994243.16543.31
6238708-23870844.81144.96
20min1249266-24926646.79347.131.7447.0447.381.73
2256788-25678848.20548.46
3252502-25250247.40047.65
4250310-25031046.98947.24
5244000-24400045.80446.05
6253477-25347747.58347.84
30min1266343-26634349.99950.161.3050.3550.511.31
2272511-27251151.15751.52
3268370-26837050.37950.74
4265668-26566849.87250.22
5262045-26204549.19249.54
6268131-26813150.33450.69
45min1280455-28045552.64852.510.9953.1152.981.00
2283029-28302953.13153.61
3281462-28146252.83753.31
4278104-27810452.20652.67
5275164-27516451.65552.11
6280114-28011452.58453.05
60min1285209-28520953.54053.570.8554.1254.160.85
2288945-28894554.24254.84
3287212-28721253.91654.50
4283645-28364553.24753.83
5282273-28227352.98953.56
6284980-28498053.49754.08
极限1291074-29107454.64154.410.7555.3455.110.75
2292083-29208354.83155.54
3291505-29150554.72255.43
4287552-28755253.98054.68
5286897-28689753.85754.54
6289808-28980854.40455.11
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