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%
110.413296623296633300023289493289163294380.15
210.483306343308703307520.06
单位质量响应值RSD%判断
31646.3031560.310.20数据可信
供试品溶液-2024010511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%
5min199718-9971828.28429.575.6628.2829.575.65
2100193-10019328.41928.42
3115759-11575932.83432.83
4103879-10387929.46429.46
5103471-10347129.34929.35
6102438-10243829.05629.06
10min1141017-14101739.99839.812.5140.0639.872.51
2136303-13630338.66138.72
3146563-14656341.57141.64
4138337-13833739.23839.30
5140906-14090639.96740.03
6138955-13895539.41339.48
15min1172688-17268848.98249.202.7949.1349.352.79
2166355-16635547.18547.33
3180097-18009751.08351.25
4170436-17043648.34348.50
5174227-17422749.41849.57
6176911-17691150.17950.33
20min1191215-19121554.23755.102.5954.5055.372.59
2185754-18575452.68852.94
3199042-19904256.45756.74
4195159-19515955.35555.62
5196022-19602255.60055.86
6198412-19841256.27856.54
30min1212988-21298860.41261.472.5360.7961.852.53
2207490-20749058.85359.22
3219901-21990162.37362.78
4217957-21795761.82262.20
5219780-21978062.33962.73
6222122-22212263.00363.39
45min1229061-22906164.97166.092.1765.4966.612.17
2225447-22544763.94664.45
3233009-23300966.09166.63
4234534-23453466.52467.04
5236650-23665067.12467.65
6239263-23926367.86568.39
60min1241372-24137268.46369.172.3069.1269.842.30
2233987-23398766.36867.01
3247644-24764470.24270.93
4244507-24450769.35270.02
5246230-24623069.84170.52
6249543-24954370.78171.46
极限1249340-24934070.72371.521.8871.5472.341.89
2244223-24422369.27270.06
3254360-25436072.14772.99
4252715-25271571.68172.50
5254763-25476372.26173.09
6257543-25754373.05073.89
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%
110.413300493295033290113289923282333291580.21
210.483298853293343296100.12
单位质量响应值RSD%判断
31619.4031451.340.38数据可信
供试品溶液-2024010511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%
5min199230-9923028.20728.035.1328.2128.035.13
299608-9960828.31428.31
3100633-10063328.60528.61
4101274-10127428.78828.79
588533-8853325.16625.17
6102302-10230229.08029.08
10min1156099-15609944.37244.232.7644.4344.302.76
2155228-15522844.12444.19
3158590-15859045.08045.14
4161692-16169245.96246.03
5152376-15237643.31443.37
6149683-14968342.54842.61
15min1181519-18151951.59851.982.2651.7652.142.26
2185091-18509152.61352.77
3186452-18645253.00053.16
4187480-18748053.29253.46
5179562-17956251.04151.19
6177105-17710550.34350.50
20min1201302-20130257.22157.142.2257.5057.422.23
2201998-20199857.41957.70
3205663-20566358.46158.74
4205636-20563658.45358.74
5195753-19575355.64455.91
6195740-19574055.64055.91
30min1224603-22460363.84463.511.9864.2563.911.99
2222992-22299263.38663.79
3225088-22508863.98264.39
4230260-23026065.45265.87
5220189-22018962.59062.98
6217408-21740861.79962.19
45min1247178-24717870.26169.053.0770.8169.603.06
2239370-23937068.04268.59
3246439-24643970.05170.60
4253833-25383372.15372.71
5235764-23576467.01767.55
6234915-23491566.77667.31
60min1261525-26152574.34071.923.3075.0472.623.29
2249343-24934370.87771.57
3251341-25134171.44572.15
4265048-26504875.34176.06
5245648-24564869.82670.50
6245250-24525069.71370.39
极限1261886-26188674.44274.563.6075.3175.423.58
2256705-25670572.96973.82
3256205-25620572.82773.70
4277637-27763778.92079.81
5268999-26899976.46477.30
6252451-25245171.76072.60
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%
110.413292403294343294133291033291953292770.05
210.483295003295253295120.01
单位质量响应值RSD%判断
31630.8431441.980.43数据可信
供试品溶液-2024010611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%
5min1111649-11164931.73633.7810.6931.7433.7810.69
2101425-10142528.83028.83
3137330-13733039.03539.04
4113324-11332432.21232.21
5127022-12702236.10536.11
6122280-12228034.75834.76
10min1156059-15605944.35946.765.7644.4346.845.77
2154480-15448043.91043.97
3179243-17924350.94951.04
4159737-15973745.40545.48
5168493-16849347.89347.97
6169027-16902748.04548.12
15min1188671-18867153.62954.442.9153.8054.622.93
2184976-18497652.57952.74
3200849-20084957.09057.29
4188208-18820853.49753.67
5192896-19289654.83055.02
6193554-19355455.01755.20
20min1205319-20531958.36158.951.8358.6559.261.86
2203307-20330757.78958.07
3213790-21379060.76961.10
4205046-20504658.28358.57
5209497-20949759.54959.86
6207475-20747558.97459.28
30min1225500-22550064.09764.470.6364.5264.900.66
2225631-22563164.13564.54
3229147-22914765.13465.60
4225980-22598064.23464.65
5227646-22764664.70765.15
6226963-22696364.51364.95
45min1241959-24195968.77668.980.2769.3469.550.29
2241879-24187968.75369.30
3243146-24314669.11369.72
4242672-24267268.97869.54
5243484-24348469.20969.79
6242851-24285169.02969.61
60min1244980-24498069.63470.820.9870.3571.550.97
2250697-25069771.25971.96
3247572-24757270.37171.13
4251386-25138671.45572.17
5250459-25045971.19271.93
6249898-24989871.03271.77
极限1257401-25740173.16573.050.9774.0373.930.93
2259429-25942973.74274.60
3253306-25330672.00172.92
4259780-25978073.84174.72
5255131-25513172.52073.42
6256878-25687873.01673.91
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%
110.413295923297613293033295763294573295380.06
210.483277753288693283220.24
单位质量响应值RSD%判断
31655.9131328.440.74数据可信
供试品溶液-2024010611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%
5min1111197-11119731.65231.043.7031.6531.043.69
2110213-11021331.37231.37
3114915-11491532.71132.71
4103081-10308129.34229.34
5107359-10735930.56030.56
6107590-10759030.62530.63
10min1162860-16286046.35845.612.2646.4345.682.26
2162208-16220846.17246.24
3164691-16469146.87946.95
4154972-15497244.11344.18
5158124-15812445.01045.08
6158621-15862145.15145.22
15min1190613-19061354.25853.591.7654.4353.761.76
2191067-19106754.38754.56
3191702-19170254.56854.74
4183789-18378952.31652.48
5186701-18670153.14453.31
6185640-18564052.84253.01
20min1207283-20728359.00358.681.3259.3058.971.33
2208104-20810459.23759.53
3209675-20967559.68459.98
4202241-20224157.56857.85
5205064-20506458.37158.66
6204442-20444258.19458.48
30min1227960-22796064.88964.730.8565.3165.150.86
2227763-22776364.83365.26
3230198-23019865.52665.96
4224409-22440963.87864.29
5227742-22774264.82765.24
6226310-22631064.41964.83
45min1244814-24481469.68669.350.4470.2669.920.45
2244788-24478869.67970.25
3244149-24414969.49770.07
4242781-24278169.10869.66
5242686-24268669.08169.64
6242624-24262469.06369.62
60min1254415-25441572.41971.870.9073.1472.580.91
2253797-25379772.24372.97
3254786-25478672.52573.26
4248914-24891470.85371.56
5251344-25134471.54572.26
6251558-25155871.60672.32
极限1259994-25999474.00773.591.1774.8974.461.16
2260664-26066474.19875.08
3260993-26099374.29275.18
4257663-25766373.34474.20
5258921-25892173.70274.57
6252915-25291571.99272.86
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