利伐沙班口崩片项目信息
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对照品来源中检所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)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%
115.199758189761089750529744249743839751570.09
215.239736779738549737660.02
单位质量响应值RSD%判断
64197.3063937.360.29数据可信
供试品溶液-2024122521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%
5min1189630-18963017.68817.113.4817.6917.113.47
2189064-18906417.63517.64
3185143-18514317.27017.27
4176950-17695016.50516.51
5174288-17428816.25716.26
6185439-18543917.29717.30
10min1261779-26177924.41824.171.1724.4524.201.18
2262588-26258824.49324.52
3259271-25927124.18424.21
4256792-25679223.95323.98
5254556-25455623.74423.77
6259878-25987824.24124.27
15min1291112-29111227.15427.030.5527.2227.100.55
2291899-29189927.22827.30
3289631-28963127.01627.09
4287963-28796326.86026.93
5288115-28811526.87526.94
6289907-28990727.04227.11
20min1308473-30847328.77428.700.4928.8928.820.49
2309802-30980228.89729.01
3307802-30780228.71128.83
4306494-30649428.58928.70
5305597-30559728.50528.62
6308026-30802628.73228.85
30min1326742-32674230.47830.440.5930.6430.600.60
2329278-32927830.71430.88
3327326-32732630.53230.69
4324336-32433630.25330.41
5324239-32423930.24430.40
6326180-32618030.42530.59
45min1340150-34015031.72831.730.4731.9431.940.48
2341980-34198031.89932.11
3341717-34171731.87432.09
4338177-33817731.54431.75
5338467-33846731.57131.78
6340319-34031931.74431.96
60min1347069-34706932.37432.380.4832.6432.650.48
2348939-34893932.54832.82
3349423-34942332.59332.86
4345516-34551632.22932.49
5346035-34603532.27732.54
6346063-34606332.28032.55
极限1351710-35171032.80732.760.5133.1333.080.51
2352395-35239532.87033.19
3353684-35368432.99133.31
4348919-34891932.54632.86
5349582-34958232.60832.92
6351116-35111632.75133.07
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
115.199746489760239736619744609748509747280.09
215.239751349787539769440.27
单位质量响应值RSD%判断
64169.0664146.030.03数据可信
供试品溶液-t3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%
5min1171228-17122815.94915.3810.8515.9515.3810.84
2128915-12891512.00812.01
3176294-17629416.42116.42
4169181-16918115.75815.76
5171665-17166515.99015.99
6173526-17352616.16316.16
10min1253224-25322423.58723.700.9023.6123.730.89
2254703-25470323.72423.74
3257589-25758923.99324.02
4251206-25120623.39923.43
5256349-25634923.87823.90
6253728-25372823.63423.66
15min1286102-28610226.64926.810.6126.7226.870.62
2287417-28741726.77226.83
3289343-28934326.95127.02
4285742-28574226.61626.68
5290190-29019027.03027.10
6288008-28800826.82726.89
20min1305842-30584228.48828.500.4628.6028.610.47
2304846-30484628.39528.50
3306989-30698928.59528.71
4304503-30450328.36328.47
5308227-30822728.71028.82
6305544-30554428.46028.57
30min1325370-32537030.30730.310.4030.4630.460.41
2325190-32519030.29030.44
3327078-32707830.46630.63
4323320-32332030.11630.27
5326301-32630130.39430.55
6324960-32496030.26930.43
45min1338706-33870631.54931.620.1831.7631.830.19
2338950-33895031.57231.77
3340291-34029131.69731.91
4339429-33942931.61631.82
5339987-33998731.66831.88
6339536-33953631.62631.84
60min1349303-34930332.53632.370.3932.8032.630.39
2348104-34810432.42432.68
3348553-34855332.46632.73
4345925-34592532.22132.48
5346901-34690132.31232.58
6346238-34623832.25132.51
极限1349652-34965232.56932.720.4332.8833.040.42
2352548-35254832.83833.15
3353495-35349532.92733.24
4349977-34997732.59932.91
5351366-35136632.72833.04
6350855-35085532.68133.00
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
115.199753749755489758399749859746029752700.05
215.239791049771569781300.15
单位质量响应值RSD%判断
64204.7464223.900.03数据可信
供试品溶液-2024122621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%
5min1198099-19809918.43618.762.1318.4418.762.12
2196157-19615718.25518.26
3202385-20238518.83518.83
4208473-20847319.40119.40
5202992-20299218.89118.89
6201210-20121018.72518.73
10min1262819-26281924.45924.490.2224.4924.520.22
2262381-26238124.41824.45
3263983-26398324.56724.60
4263126-26312624.48724.52
5263154-26315424.49024.52
6263668-26366824.53824.57
15min1293005-29300527.26827.100.4927.3427.170.48
2292399-29239927.21227.28
3291311-29131127.11027.18
4290292-29029227.01627.09
5289130-28913026.90726.98
6291121-29112127.09327.16
20min1308362-30836228.69728.650.6028.8128.760.60
2310890-31089028.93229.05
3307984-30798428.66228.78
4306612-30661228.53428.65
5305547-30554728.43528.55
6307448-30744828.61228.73
30min1327648-32764830.49230.350.5130.6630.520.51
2328086-32808630.53330.70
3327056-32705630.43730.60
4324656-32465630.21430.38
5325093-32509330.25430.42
6324280-32428030.17930.34
45min1342346-34234631.86031.570.6232.0831.780.62
2340549-34054931.69331.91
3339444-33944431.59031.81
4338779-33877931.52831.74
5337487-33748731.40831.62
6336546-33654631.32031.54
60min1347267-34726732.31832.240.4532.5932.510.45
2348721-34872132.45332.72
3347046-34704632.29732.57
4345423-34542332.14632.41
5344593-34459332.06932.34
6345343-34534332.13932.41
极限1351803-35180332.74032.540.7333.0632.860.73
2351843-35184332.74433.07
3352066-35206632.76433.09
4348149-34814932.40032.72
5347822-34782232.36932.69
6346324-34632432.23032.55
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
115.199754939751059755079754079760819755190.04
215.239798219817149807680.14
单位质量响应值RSD%判断
64221.1364397.110.20数据可信
供试品溶液-t3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%
5min1186584-18658417.33917.192.0017.3417.192.00
2181014-18101416.82116.82
3188279-18827917.49617.50
4180356-18035616.76016.76
5189080-18908017.57117.57
6184306-18430617.12717.13
10min1259369-25936924.10223.990.7824.1324.020.78
2256026-25602623.79223.82
3260416-26041624.20024.23
4256101-25610123.79923.83
5260066-26006624.16724.20
6257152-25715223.89623.92
15min1291024-29102427.04427.150.8127.1127.220.82
2294484-29448427.36527.43
3295787-29578727.48627.56
4290839-29083927.02727.09
5290507-29050726.99627.07
6290261-29026126.97327.04
20min1309252-30925228.73828.840.9528.8528.950.95
2313987-31398729.17829.29
3314170-31417029.19529.31
4307874-30787428.61028.72
5308709-30870928.68728.80
6308042-30804228.62528.74
30min1329368-32936830.60730.581.0330.7730.741.02
2333192-33319230.96231.12
3332722-33272230.91931.08
4327150-32715030.40130.56
5327056-32705630.39230.55
6324714-32471430.17430.34
45min1344341-34434131.99831.890.8132.2132.100.81
2346254-34625432.17632.39
3346147-34614732.16632.38
4341038-34103831.69131.90
5340657-34065731.65631.87
6340466-34046631.63831.85
60min1350629-35062932.58332.540.5732.8532.810.57
2351873-35187332.69832.97
3352924-35292432.79633.07
4348589-34858932.39332.66
5348333-34833332.36932.64
6348516-34851632.38632.65
极限1353962-35396232.89232.920.8233.2133.240.81
2357380-35738033.21033.53
3358201-35820133.28633.61
4352724-35272432.77733.10
5352197-35219732.72833.05
6351150-35115032.63132.95
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