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)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%
110.323300083294603295543295643296883296550.07
210.243290443293953292200.08
单位质量响应值RSD%判断
31943.3132150.390.46数据可信
供试品溶液-2024122521批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241368-24136867.51566.813.7067.5266.813.70
2243638-24363868.15068.15
3225484-22548463.07263.07
4230479-23047964.46964.47
5247810-24781069.31769.32
6244364-24436468.35368.35
10min1310016-31001686.71786.802.7286.8386.922.72
2317265-31726588.74588.86
3296415-29641582.91383.02
4314035-31403587.84187.95
5305276-30527685.39185.51
6318899-31889989.20289.32
15min1326104-32610491.21791.232.6491.4791.482.64
2333091-33309193.17293.43
3314814-31481488.05988.30
4332046-33204692.87993.13
5316512-31651288.53488.79
6334291-33429193.50793.77
20min1331423-33142392.70592.802.4893.1193.202.48
2338997-33899794.82495.24
3321785-32178590.00990.40
4336957-33695794.25394.66
5321846-32184690.02690.43
6339474-33947494.95795.38
30min1339011-33901194.82894.442.3495.3995.002.34
2344550-34455096.37796.95
3328535-32853591.89792.44
4342540-34254095.81596.38
5327071-32707191.48892.04
6344109-34410996.25496.83
45min1343467-34346796.07495.572.3796.8096.292.37
2349927-34992797.88198.62
3332582-33258293.02993.72
4346411-34641196.89897.62
5330615-33061592.47993.19
6346936-34693697.04497.78
60min1346306-34630696.86896.072.2597.7596.952.25
2350198-35019897.95798.86
3334482-33448293.56194.41
4348312-34831297.42998.32
5332791-33279193.08893.95
6348643-34864397.52298.42
极限1349584-34958497.78597.091.0798.8398.131.08
2349923-34992397.88098.94
3344228-34422896.28797.29
4348621-34862197.51698.57
5340913-34091395.36096.38
6349336-34933697.71698.78
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)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%
110.323298023297593298033297243297253297630.02
210.243307743304383306060.08
单位质量响应值RSD%判断
31953.7832285.740.74数据可信
供试品溶液-2024122621批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1243317-24331767.90767.063.3667.9167.063.36
2232575-23257564.90964.91
3241366-24136667.36267.36
4234465-23446565.43665.44
5235500-23550065.72565.73
6254399-25439971.00071.00
10min1320510-32051089.45087.662.1889.5687.782.18
2308653-30865386.14186.25
3306141-30614185.44085.55
4321436-32143689.70989.82
5309224-30922486.30186.41
6318688-31868888.94289.06
15min1332492-33249292.79592.281.5893.0692.541.58
2325071-32507190.72390.98
3327065-32706591.28091.53
4338863-33886394.57394.83
5327020-32702091.26791.52
6333326-33332693.02793.29
20min1343936-34393695.98894.771.4696.4195.181.46
2334069-33406993.23593.64
3335787-33578793.71494.12
4346055-34605596.58097.00
5336044-33604493.78694.19
6341585-34158595.33295.75
30min1346886-34688696.81296.291.3097.3996.861.30
2340606-34060695.05995.62
3342677-34267795.63796.20
4352333-35233398.33298.91
5341048-34104895.18295.74
6346587-34658796.72897.31
45min1349977-34997797.67497.421.6298.4198.151.61
2344368-34436896.10996.83
3346049-34604996.57897.30
4359202-359202100.249100.99
5344412-34441296.12196.84
6350341-35034197.77698.52
60min1351265-35126598.03497.651.4398.9398.541.43
2345268-34526896.36097.24
3348382-34838297.22998.11
4358342-358342100.009100.92
5344755-34475596.21797.10
6351224-35122498.02298.93
极限1352775-35277598.45597.771.3599.5298.831.35
2345563-34556396.44297.48
3347807-34780797.06998.11
4357959-35795999.902100.98
5346320-34632096.65497.69
6351539-35153998.11099.18
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)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%
110.323311143306953307133308973309283308690.06
210.243305843308373307100.06
单位质量响应值RSD%判断
32060.9532295.900.52数据可信
供试品溶液-2024122721批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1238162-23816266.34665.296.6066.3565.296.60
2212445-21244559.18259.18
3219108-21910861.03861.04
4237450-23745066.14866.15
5249922-24992269.62269.62
6249088-24908869.39069.39
10min1312716-31271687.11586.961.6087.2387.071.61
2306608-30660885.41385.51
3306424-30642485.36285.46
4312164-31216486.96187.07
5318661-31866188.77188.89
6316332-31633288.12288.24
15min1327727-32772791.29792.191.1691.5592.451.17
2330498-33049892.06992.31
3326386-32638690.92391.17
4330359-33035992.03092.29
5336583-33658393.76494.03
6334135-33413593.08293.34
20min1334322-33432293.13494.201.1293.5494.601.12
2339069-33906994.45694.85
3333681-33368192.95593.35
4337997-33799794.15894.57
5343833-34383395.78396.20
6339937-33993794.69895.12
30min1340242-34024294.78396.111.1295.3596.681.12
2346833-34683396.61997.17
3341313-34131395.08195.63
4343791-34379195.77296.34
5350067-35006797.52098.10
6347788-34778896.88597.46
45min1343658-34365895.73597.521.0296.4698.241.02
2351184-35118497.83198.54
3352687-35268798.25098.96
4348368-34836897.04797.77
5353256-35325698.40899.15
6351249-35124997.84998.59
60min1345493-34549396.24697.651.1497.1398.541.14
2352482-35248298.19399.07
3347052-34705296.68097.55
4349541-34954197.37498.26
5356418-35641899.289100.20
6352183-35218398.11099.01
极限1350741-35074197.70897.970.9598.7599.020.95
2355616-35561699.066100.11
3346783-34678396.60597.64
4350030-35003097.51098.56
5355147-35514798.935100.01
6351845-35184598.01599.08
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