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%
112.179577589595439585089587549585739586270.07
212.249584929602529593720.13
单位质量响应值RSD%判断
78769.6878380.070.36数据可信
供试品溶液-2023073011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%
5min1213993-21399320.34420.035.0020.3420.035.00
2224233-22423321.31821.32
3213256-21325620.27420.27
4193723-19372318.41718.42
5203967-20396719.39119.39
6215115-21511520.45120.45
10min1263258-26325825.02824.822.1325.0624.862.14
2267306-26730625.41325.45
3263434-26343425.04425.08
4251962-25196223.95423.98
5257157-25715724.44824.48
6263605-26360525.06125.09
15min1280222-28022226.64026.580.8926.7226.660.90
2283099-28309926.91426.99
3281062-28106226.72026.80
4275845-27584526.22426.29
5278303-27830326.45826.53
6279215-27921526.54526.62
20min1288063-28806327.38627.360.5227.5127.480.52
2289917-28991727.56227.68
3288402-28840227.41827.54
4286266-28626627.21527.33
5288065-28806527.38627.50
6285868-28586827.17727.30
30min1297249-29724928.25928.190.6228.4228.360.60
2297954-29795428.32628.49
3297644-29764428.29728.46
4295597-29559728.10228.26
5297585-29758528.29128.45
6293271-29327127.88128.05
45min1303671-30367128.87028.740.6329.0828.950.63
2303204-30320428.82529.04
3302908-30290828.79729.01
4301864-30186428.69828.90
5303409-30340928.84529.05
6298647-29864728.39228.60
60min1305688-30568829.06129.040.4729.3229.300.47
2306605-30660529.14929.41
3305498-30549829.04329.30
4304798-30479828.97729.23
5307065-30706529.19229.45
6303041-30304128.81029.07
极限1307306-30730629.21529.140.6529.5229.450.65
2308788-30878829.35629.67
3306030-30603029.09429.40
4306378-30637829.12729.43
5307784-30778429.26129.57
6303026-30302628.80829.12
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%
112.179583619584849588669590169591319587720.04
212.249606999610019608500.03
单位质量响应值RSD%判断
78781.5978500.820.26数据可信
供试品溶液-2023073011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%
5min1226591-22659121.52420.724.3921.5220.724.40
2214369-21436920.36320.36
3217131-21713120.62520.62
4201307-20130719.12219.12
5225998-22599821.46721.47
6223267-22326721.20821.21
10min1266530-26653025.31725.081.2725.3525.121.28
2260768-26076824.77024.80
3266073-26607325.27425.31
4258888-25888824.59124.62
5266437-26643725.30825.34
6265652-26565225.23425.27
15min1280385-28038526.63326.650.5926.7126.720.59
2278235-27823526.42926.50
3283055-28305526.88726.96
4279485-27948526.54826.62
5281051-28105126.69726.77
6281271-28127126.71826.79
20min1288380-28838027.39327.430.5127.5227.550.51
2287446-28744627.30427.42
3291360-29136027.67627.80
4289061-28906127.45827.57
5288833-28883327.43627.56
6287340-28734027.29427.42
30min1294678-29467827.99128.170.8828.1628.330.88
2295464-29546428.06628.23
3300022-30002228.49928.67
4299680-29968028.46628.63
5294928-29492828.01528.18
6294352-29435227.96028.13
45min1300090-30009028.50528.781.1328.7229.001.11
2302988-30298828.78028.99
3306016-30601629.06829.28
4308175-30817529.27329.48
5300847-30084728.57728.79
6299956-29995628.49228.71
60min1302816-30281628.76429.020.8829.0329.280.87
2306522-30652229.11629.38
3309437-30943729.39329.66
4307149-30714929.17629.43
5304596-30459628.93329.20
6302573-30257328.74129.00
极限1304754-30475428.94829.070.8029.2629.380.78
2306602-30660229.12429.43
3308778-30877829.33029.64
4308828-30882829.33529.64
5304763-30476328.94929.26
6302790-30279028.76229.07
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%
112.179592799601279593649581029583419590430.09
212.249605359619129612240.11
单位质量响应值RSD%判断
78803.8678531.370.25数据可信
供试品溶液-20210818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%
5min1240125-24012522.80122.015.4522.8022.015.45
2244691-24469123.23523.24
3235291-23529122.34222.34
4230906-23090621.92621.93
5231046-23104621.93921.94
6208388-20838819.78819.79
10min1278572-27857226.45225.822.9726.4925.852.98
2279549-27954926.54526.58
3276164-27616426.22426.26
4269460-26946025.58725.62
5269421-26942125.58325.62
6258022-25802224.50124.53
15min1293628-29362827.88227.491.5927.9627.571.60
2293743-29374327.89327.98
3292899-29289927.81327.89
4287010-28701027.25427.33
5286916-28691627.24527.32
6282765-28276526.85026.92
20min1302268-30226828.70228.351.3228.8328.481.32
2302874-30287428.76028.89
3300584-30058428.54228.67
4297265-29726528.22728.35
5295254-29525428.03628.16
6293266-29326627.84827.97
30min1311421-31142129.57229.260.9929.7529.440.99
2309994-30999429.43629.61
3310702-31070229.50329.68
4307469-30746929.19629.37
5305127-30512728.97429.15
6304154-30415428.88129.05
45min1317622-31762230.16029.880.7830.3930.100.80
2316597-31659730.06330.29
3316307-31630730.03530.26
4313228-31322829.74329.96
5311968-31196829.62329.84
6312345-31234529.65929.87
60min1321532-32153230.53230.180.9330.8130.450.94
2318906-31890630.28230.56
3320383-32038330.42330.70
4316644-31664430.06730.34
5314508-31450829.86530.13
6314698-31469829.88330.15
极限1320379-32037930.42230.230.8130.7530.560.82
2319671-31967130.35530.68
3319205-31920530.31130.64
4320646-32064630.44830.77
5315798-31579829.98730.31
6314525-31452529.86630.18
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%
112.179572329579209578799582149578459578180.04
212.249633959630669632300.03
单位质量响应值RSD%判断
78703.2078695.260.01数据可信
供试品溶液-20210818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%
5min1237674-23767422.56022.281.3022.5622.281.29
2236779-23677922.47522.47
3233125-23312522.12822.13
4237095-23709522.50522.50
5229746-22974621.80721.81
6234178-23417822.22822.23
10min1274697-27469726.07425.931.0826.1125.961.08
2275574-27557426.15726.19
3270860-27086025.71025.75
4276953-27695326.28826.33
5270153-27015325.64225.68
6270619-27061925.68725.72
15min1291186-29118627.63927.500.9927.7227.580.99
2291749-29174927.69227.77
3286873-28687327.23027.31
4293163-29316327.82727.91
5285895-28589527.13727.22
6289364-28936427.46627.55
20min1298225-29822528.30728.370.7728.4328.500.76
2301039-30103928.57428.70
3296927-29692728.18428.31
4302438-30243828.70728.83
5297362-29736228.22528.35
6297460-29746028.23428.36
30min1308946-30894629.32529.310.7929.5029.480.80
2310717-31071729.49329.67
3306496-30649629.09229.26
4312497-31249729.66229.84
5306985-30698529.13929.31
6307009-30700929.14129.31
45min1314155-31415529.81929.890.8230.0430.110.82
2316421-31642130.03430.26
3312535-31253529.66529.89
4319172-31917230.29530.52
5314743-31474329.87530.09
6312366-31236629.64929.87
60min1316255-31625530.01830.140.4830.2930.410.49
2319444-31944430.32130.60
3316051-31605129.99930.27
4319386-31938630.31630.59
5316983-31698330.08730.36
6316973-31697330.08730.36
极限1317453-31745330.13230.240.5230.4630.570.52
2319265-31926530.30430.63
3316362-31636230.02930.35
4320597-32059730.43130.76
5317898-31789830.17430.49
6320155-32015530.38930.71
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