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%
112.134802064794434802784806884805054802240.10
212.074785254781284783260.06
单位质量响应值RSD%判断
39589.7839629.330.08数据可信
长期6月-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%
5min1157260-15726029.65828.454.8429.6628.454.84
2153746-15374628.99529.00
3159822-15982230.14130.14
4148614-14861428.02728.03
5141606-14160626.70626.71
6144072-14407227.17127.17
10min1205878-20587838.82738.292.9138.8938.362.91
2204972-20497238.65638.72
3211805-21180539.94440.01
4202602-20260238.20938.27
5197136-19713637.17837.24
6195955-19595536.95537.02
15min1231830-23183043.72143.561.3743.8743.711.38
2231223-23122343.60743.76
3235936-23593644.49544.65
4231519-23151943.66243.81
5228700-22870043.13143.27
6226639-22663942.74242.88
20min1248977-24897746.95546.730.6047.2046.980.61
2247806-24780646.73446.98
3249560-24956047.06547.32
4247966-24796646.76447.01
5246987-24698746.58046.82
6245413-24541346.28346.52
30min1265603-26560350.09050.220.3650.4450.570.35
2264861-26486149.95050.30
3266640-26664050.28650.65
4267023-26702350.35850.71
5266301-26630150.22250.56
6267417-26741750.43250.77
45min1279067-27906752.63052.830.3953.0953.290.38
2279339-27933952.68153.14
3279429-27942952.69853.17
4280465-28046552.89353.35
5280596-28059652.91853.37
6281936-28193653.17153.62
60min1285826-28582653.90454.090.5054.4954.670.49
2285639-28563953.86954.45
3285541-28554153.85054.44
4287404-28740454.20254.78
5287269-28726954.17654.75
6289175-28917554.53655.11
极限1291887-29188755.04755.260.3955.7555.960.37
2292202-29220255.10755.81
3292288-29228855.12355.83
4293212-29321255.29756.00
5293480-29348055.34856.04
6294909-29490955.61756.31
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%
112.134784994787284781984790934774354783910.14
212.074790514784464787480.09
单位质量响应值RSD%判断
39438.6639664.290.41数据可信
长期6月-供试品溶液-2024010911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%
5min1134849-13484925.46927.283.6825.4727.283.68
2148083-14808327.96827.97
3147760-14776027.90727.91
4149096-14909628.16028.16
5142762-14276226.96326.96
6143983-14398327.19427.19
10min1199412-19941237.66338.231.5037.7238.291.50
2204591-20459138.64138.70
3202494-20249438.24538.31
4204540-20454038.63138.69
5198030-19803037.40237.46
6205324-20532438.77938.84
15min1228711-22871143.19643.311.1643.3443.461.16
2229657-22965743.37543.52
3227545-22754542.97643.12
4230909-23090943.61243.76
5225786-22578642.64442.79
6233400-23340044.08244.23
20min1245577-24557746.38246.270.9546.6246.510.95
2244523-24452346.18346.43
3243776-24377646.04246.28
4246247-24624746.50946.75
5241428-24142845.59845.84
6248254-24825446.88847.13
30min1263257-26325749.72149.630.6850.0649.980.68
2262140-26214049.51049.86
3260617-26061749.22349.57
4263440-26344049.75650.10
5261555-26155549.40049.74
6265708-26570850.18450.53
45min1276654-27665452.25152.090.6752.7052.540.67
2275802-27580252.09152.55
3274123-27412351.77352.23
4276034-27603452.13452.59
5273513-27351351.65852.11
6278655-27865552.62953.09
60min1283781-28378153.59853.440.4254.1654.010.42
2282828-28282853.41853.99
3281647-28164753.19453.76
4282892-28289253.43054.00
5281830-28183053.22953.79
6284706-28470653.77254.35
极限1287273-28727354.25754.260.3954.9454.950.39
2287162-28716254.23654.93
3286774-28677454.16354.85
4286914-28691454.18954.88
5286251-28625154.06454.75
6289409-28940954.66055.36
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%
112.134772144788274766614766964767614772320.20
212.074782694781944782320.02
单位质量响应值RSD%判断
39343.1239621.540.50数据可信
长期6月-供试品溶液-2024010811批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1171528-17152832.45332.622.7932.4532.622.79
2172938-17293832.72032.72
3170546-17054632.26732.27
4180595-18059534.16934.17
5165806-16580631.37131.37
6172964-17296432.72532.72
10min1218186-21818641.28141.521.4941.3541.591.49
2221411-22141141.89141.96
3217816-21781641.21141.28
4223441-22344142.27542.35
5214426-21442640.57040.64
6221342-22134241.87841.95
15min1242675-24267545.91446.161.0946.0846.321.09
2243996-24399646.16446.33
3243733-24373346.11546.28
4246932-24693246.72046.89
5239791-23979145.36945.53
6246583-24658346.65446.82
20min1255990-25599048.43448.771.0048.7049.031.00
2258572-25857248.92249.19
3256069-25606948.44848.71
4261567-26156749.48949.76
5254784-25478448.20548.47
6259475-25947549.09349.36
30min1268964-26896450.88851.280.9051.2651.650.91
2272087-27208751.47951.86
3268982-26898250.89251.27
4274066-27406651.85452.24
5268666-26866650.83251.20
6273296-27329651.70852.09
45min1277542-27754252.51153.180.9953.0053.670.99
2282017-28201753.35853.85
3279929-27992952.96353.45
4284393-28439353.80754.31
5278732-27873252.73653.22
6283724-28372453.68154.17
60min1280915-28091553.14954.161.2253.7554.761.22
2288179-28817954.52455.13
3285275-28527553.97454.58
4290404-29040454.94555.56
5284071-28407153.74654.34
6288575-28857554.59955.21
极限1285862-28586254.08554.861.0254.8155.591.02
2291465-29146555.14555.88
3289858-28985854.84155.57
4292801-29280155.39856.14
5287120-28712054.32355.04
6292739-29273955.38656.12
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%
112.134786774790414804364787114782524790230.18
212.074770274786674778470.25
单位质量响应值RSD%判断
39490.7739589.640.18数据可信
长期6月-供试品溶液-2024010911批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175066-17506633.07433.092.1433.0733.092.14
2176214-17621433.29133.29
3174323-17432332.93332.93
4179566-17956633.92433.92
5177200-17720033.47733.48
6168466-16846631.82731.83
10min1225067-22506742.52042.061.0442.5942.141.03
2221369-22136941.82141.90
3220422-22042241.64341.72
4223920-22392042.30342.38
5224998-22499842.50742.58
6220040-22004041.57041.64
15min1247037-24703746.67146.350.7046.8446.510.70
2244311-24431146.15646.32
3242724-24272445.85646.02
4247026-24702646.66946.84
5246071-24607146.48846.66
6244767-24476746.24246.40
20min1259129-25912948.95548.680.5549.2348.950.55
2256610-25661048.47948.75
3255781-25578148.32348.59
4259373-25937349.00149.27
5257832-25783248.71048.98
6257398-25739848.62848.89
30min1271973-27197351.38251.470.5251.7651.850.51
2271251-27125151.24551.62
3270926-27092651.18451.56
4273977-27397751.76052.14
5272275-27227551.43951.82
6274283-27428351.81852.19
45min1281472-28147253.17653.460.5553.6753.950.55
2282165-28216553.30753.80
3281184-28118453.12253.61
4284571-28457153.76254.26
5283669-28366953.59154.09
6284648-28464853.77654.27
60min1286942-28694254.21054.310.3554.8254.920.35
2288468-28846854.49855.11
3285843-28584354.00254.61
4287494-28749454.31454.93
5287503-28750354.31654.93
6288515-28851554.50755.12
极限1291934-29193455.15355.100.4355.8955.830.43
2291485-29148555.06855.80
3290361-29036154.85655.58
4293516-29351655.45256.19
5290250-29025054.83555.57
6292404-29240455.24255.97
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