利伐沙班颗粒项目信息
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430060-202202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400
标示量(mg)30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%
112.179646999637139637709635239631879637780.06
212.249648579644609646580.03
单位质量响应值RSD%判断
79192.9378811.930.35数据可信
供试品溶液-2023072811批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1216912-21691220.51020.263.6720.5120.263.66
2226570-22657021.42321.42
3215048-21504820.33420.33
4212689-21268920.11120.11
5202380-20238019.13619.14
6211925-21192520.03820.04
10min1262667-26266724.83624.611.6524.8724.651.65
2266174-26617425.16825.20
3261177-26117724.69524.73
4259751-25975124.56124.59
5253392-25339223.95923.99
6258775-25877524.46824.50
15min1280450-28045026.51826.370.9326.5926.440.92
2282204-28220426.68426.76
3279201-27920126.40026.47
4279572-27957226.43526.51
5276570-27657026.15126.22
6275196-27519626.02126.10
20min1289290-28929027.35427.240.7427.4727.360.73
2289784-28978427.40027.52
3288115-28811527.24327.36
4289430-28943027.36727.49
5287915-28791527.22427.34
6284092-28409226.86226.98
30min1299279-29927928.29828.150.6528.4628.320.66
2298599-29859928.23428.40
3296792-29679228.06328.23
4299413-29941328.31128.48
5298097-29809728.18628.35
6294350-29435027.83227.99
45min1304566-30456628.79828.750.5529.0128.960.55
2304303-30430328.77328.99
3302517-30251728.60428.82
4306422-30642228.97429.18
5304558-30455828.79729.01
6301739-30173928.53128.74
60min1305456-30545628.88229.000.5629.1429.260.56
2307674-30767429.09229.35
3305740-30574028.90929.17
4309422-30942229.25729.52
5307124-30712429.04029.30
6304797-30479728.82029.08
极限1308804-30880429.19929.120.5129.5129.430.51
2309331-30933129.24929.56
3306088-30608828.94229.25
4309470-30947029.26229.57
5307992-30799229.12229.43
6306007-30600728.93429.24
利伐沙班颗粒项目信息
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430060-202202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400
标示量(mg)30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%
112.179646089644119654009654239666009652880.09
212.249662359665499663920.03
单位质量响应值RSD%判断
79317.0178953.590.33数据可信
供试品溶液-2023072811批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1222780-22278021.02920.372.5921.0320.372.58
2221074-22107420.86820.87
3215934-21593420.38320.38
4212295-21229520.04020.04
5215027-21502720.29820.30
6207690-20769019.60519.61
10min1265653-26565325.07724.751.3025.1124.791.30
2265185-26518525.03225.07
3262946-26294624.82124.85
4262637-26263724.79224.83
5260415-26041524.58224.62
6256437-25643724.20724.24
15min1281229-28122926.54726.400.8326.6226.480.83
2280637-28063726.49126.57
3280327-28032726.46226.54
4282170-28217026.63626.71
5277633-27763326.20726.28
6276119-27611926.06426.14
20min1289390-28939027.31727.180.6327.4427.300.63
2288143-28814327.19927.32
3288582-28858227.24127.36
4289995-28999527.37427.49
5285762-28576226.97527.09
6285813-28581326.98027.10
30min1296471-29647127.98627.920.4928.1528.090.49
2295485-29548527.89328.06
3296249-29624927.96528.13
4298089-29808928.13828.30
5294351-29435127.78527.95
6294272-29427227.77827.94
45min1302278-30227828.53428.530.5028.7528.740.50
2302529-30252928.55728.77
3302836-30283628.58628.80
4304489-30448928.74228.95
5300100-30010028.32828.54
6301120-30112028.42428.63
60min1304677-30467728.76028.790.4929.0229.050.48
2304769-30476928.76929.03
3305044-30504428.79529.05
4307769-30776929.05229.31
5303309-30330928.63128.89
6304462-30446228.74029.00
极限1306088-30608828.89328.890.5229.2029.200.53
2305879-30587928.87429.18
3306311-30631128.91429.22
4308923-30892329.16129.47
5304349-30434928.72929.03
6304897-30489728.78129.08
利伐沙班颗粒项目信息
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430060-202202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400
标示量(mg)30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%
112.179662479657149654209656259659189657850.04
212.249669159663819666480.04
单位质量响应值RSD%判断
79357.8578974.510.35数据可信
供试品溶液-2023072911批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1215625-21562520.34620.502.0120.3520.502.00
2217633-21763320.53620.54
3219341-21934120.69720.70
4224354-22435421.17021.17
5211599-21159919.96619.97
6215025-21502520.29020.29
10min1260656-26065624.59524.841.2024.6324.881.20
2266888-26688825.18325.22
3266331-26633125.13125.17
4264105-26410524.92124.96
5258935-25893524.43324.47
6262615-26261524.78024.81
15min1280815-28081526.49726.680.9226.5726.760.91
2285343-28534326.92527.00
3284960-28496026.88926.96
4282404-28240426.64726.72
5278848-27884826.31226.39
6284351-28435126.83126.91
20min1292200-29220027.57227.630.8227.6927.750.81
2296020-29602027.93228.05
3294276-29427627.76827.89
4291307-29130727.48727.61
5289358-28935827.30427.42
6293883-29388327.73127.85
30min1304042-30404228.68928.590.6928.8528.750.68
2306247-30624728.89729.06
3303270-30327028.61628.78
4301649-30164928.46328.63
5300278-30027828.33428.50
6302399-30239928.53428.70
45min1312564-31256429.49329.210.7829.7129.420.78
2312440-31244029.48229.70
3309111-30911129.16729.38
4307612-30761229.02629.24
5307929-30792929.05629.27
6307445-30744529.01029.22
60min1315455-31545529.76629.440.7930.0329.700.79
2314499-31449929.67629.94
3311530-31153029.39629.66
4310608-31060829.30929.57
5309681-30968129.22129.48
6309915-30991529.24329.51
极限1316123-31612329.82929.530.7630.1429.840.75
2315749-31574929.79430.11
3312184-31218429.45729.77
4310824-31082429.32929.64
5311394-31139429.38329.69
6311477-31147729.39129.70
利伐沙班颗粒项目信息
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430060-202202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400
标示量(mg)30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%
112.179660369680609652929656699653069660730.12
212.249666419663979665190.02
单位质量响应值RSD%判断
79381.5178963.970.38数据可信
供试品溶液-2023072911批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1230588-23058821.75620.623.4821.7620.613.50
2217427-21742720.51520.51
3214778-21477820.26520.26
4210111-21011119.82419.82
5213708-21370820.16420.16
6224366-22436621.16921.17
10min1266762-26676225.16924.621.8025.2124.651.82
2264221-26422124.93024.96
3261083-26108324.63424.67
4253645-25364523.93223.96
5257651-25765124.31024.34
6262176-26217624.73724.77
15min1283127-28312726.71326.411.1226.7926.481.12
2283051-28305126.70626.78
3281447-28144726.55526.63
4276164-27616426.05626.13
5276446-27644626.08326.16
6279247-27924726.34726.42
20min1291368-29136827.49127.300.8927.6127.420.89
2291335-29133527.48827.61
3292126-29212627.56227.68
4286454-28645427.02727.14
5286910-28691027.07027.19
6287778-28777827.15227.27
30min1299605-29960528.26828.270.8428.4428.430.83
2300695-30069528.37128.54
3303954-30395428.67828.84
4297995-29799528.11628.28
5298199-29819928.13528.30
6297033-29703328.02528.19
45min1305921-30592128.86428.850.8829.0829.060.88
2305620-30562028.83629.05
3310838-31083829.32829.54
4303710-30371028.65528.86
5305123-30512328.78929.00
6303427-30342728.62928.84
60min1311039-31103929.34729.130.9929.6129.380.98
2308045-30804529.06429.33
3313409-31340929.57129.83
4306376-30637628.90729.16
5308058-30805829.06629.32
6305217-30521728.79829.06
极限1309752-30975229.22629.190.8529.5429.500.85
2309415-30941529.19429.50
3314289-31428929.65429.96
4307985-30798529.05929.36
5308263-30826329.08529.39
6306715-30671528.93929.25
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