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%
1 15.174923494926444923134919134921724922780.06
2 15.124918704919314919000.01
单位质量响应值RSD%判断
32450.7632533.070.18数据可信
供试品溶液-2024122821批-pH1.2(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%
5min1284892-28489252.39852.105.9652.4052.105.96
2294738-29473854.20954.21
3253207-25320746.57146.57
4301746-30174655.49855.50
5287138-28713852.81152.81
6277957-27795751.12351.12
10min1372739-37273968.55567.713.6168.6467.803.62
2370896-37089668.21668.31
3342894-34289463.06663.14
4380245-38024569.93670.03
5376139-37613969.18169.27
6365903-36590367.29867.38
15min1403349-40334974.18573.481.8874.3973.681.88
2397994-39799473.20073.40
3387013-38701371.18171.36
4409303-40930375.28075.49
5402023-40202373.94174.14
6397551-39755173.11973.32
20min1420587-42058777.35676.411.3977.6876.741.40
2412258-41225875.82476.15
3408115-40811575.06275.36
4423288-42328877.85278.19
5416613-41661376.62576.95
6411955-41195575.76876.09
30min1438655-43865580.67980.031.0081.1380.481.01
2430788-43078879.23279.68
3434488-43448879.91280.34
4441126-44112681.13381.60
5435746-43574680.14480.60
6429988-42998879.08579.53
45min1451736-45173683.08582.440.9383.6783.020.94
2444482-44448281.75082.33
3443185-44318581.51282.07
4453830-45383083.47084.07
5449188-44918882.61683.20
6447031-44703182.21982.80
60min1457355-45735584.11883.740.9784.8584.460.98
2449012-44901282.58483.30
3450501-45050182.85783.55
4457921-45792184.22284.96
5457318-45731884.11184.84
6459735-45973584.55685.27
极限1465010-46501085.52684.790.6986.3985.650.69
2456459-45645983.95384.81
3459016-45901684.42485.26
4463060-46306085.16786.05
5462834-46283485.12685.99
6459677-45967784.54585.40
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%
1 15.174910614910664912784909974908474910500.04
2 15.124908614909084908840.01
单位质量响应值RSD%判断
32369.8132465.870.21数据可信
供试品溶液-2024122821批-pH1.2(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%
5min1263123-26312348.50550.083.3248.5050.083.32
2283787-28378752.31452.31
3261018-26101848.11748.12
4271803-27180350.10550.11
5280092-28009251.63351.63
6270205-27020549.81049.81
10min1363219-36321966.95766.991.2367.0467.071.23
2370136-37013668.23268.32
3362654-36265466.85366.93
4357618-35761865.92466.01
5366439-36643967.55167.64
6360242-36024266.40866.49
15min1393577-39357772.55372.360.8672.7572.560.86
2394023-39402372.63672.84
3394375-39437572.70072.89
4387563-38756371.44571.64
5396414-39641473.07673.27
6389383-38938371.78071.97
20min1410799-41079975.72875.320.8676.0475.640.86
2408283-40828375.26475.59
3410839-41083975.73576.05
4405091-40509174.67674.99
5412586-41258676.05776.38
6403848-40384874.44774.76
30min1428659-42865979.02078.770.8679.4679.210.86
2429097-42909779.10179.55
3429637-42963779.20179.64
4424055-42405578.17278.61
5430806-43080679.41679.86
6421566-42156677.71378.15
45min1443070-44307081.67781.550.5982.2582.120.59
2444577-44457781.95582.53
3444129-44412981.87282.44
4440726-44072681.24581.81
5443855-44385581.82282.40
6437915-43791580.72781.29
60min1449448-44944882.85383.361.5583.5684.071.54
2451166-45116683.16983.89
3448330-44833082.64783.35
4448662-44866282.70883.41
5449263-44926382.81983.53
6466342-46634285.96786.67
极限1456157-45615784.09084.170.3984.9385.010.39
2459716-45971684.74685.60
3456801-45680184.20885.05
4456595-45659584.17085.01
5454332-45433283.75384.61
6455876-45587684.03884.88
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%
1 15.174930104927054928044922454918324925190.10
2 15.124915184910424912800.07
单位质量响应值RSD%判断
32466.6432492.060.06数据可信
供试品溶液-2024122921批-pH1.2(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%
5min1306623-30662356.41752.174.7156.4252.174.72
2288793-28879353.13653.14
3282848-28284852.04252.04
4278500-27850051.24251.24
5277306-27730651.02351.02
6267250-26725049.17249.17
10min1379653-37965369.85467.372.3469.9567.462.34
2370241-37024168.12268.21
3363544-36354466.89066.98
4365653-36565367.27867.36
5364026-36402666.97967.06
6353746-35374665.08765.17
15min1405683-40568374.64372.142.1374.8572.342.12
2387044-38704471.21471.42
3389530-38953071.67171.87
4397091-39709173.06273.26
5391163-39116371.97272.17
6381946-38194670.27670.47
20min1420182-42018277.31174.862.2177.6575.182.22
2400505-40050573.69074.01
3406781-40678174.84575.16
4411732-41173275.75676.08
5407939-40793975.05875.37
6394180-39418072.52772.83
30min1435584-43558480.14577.942.2480.6178.382.24
2417095-41709576.74377.19
3422090-42209077.66278.10
4431228-43122879.34379.79
5426024-42602478.38678.83
6409593-40959375.36375.79
45min1447972-44797282.42480.761.7483.0281.341.74
2434006-43400679.85480.43
3439104-43910480.79281.36
4445298-44529881.93282.51
5440210-44021080.99681.57
6426993-42699378.56479.12
60min1455506-45550683.81082.221.6284.5482.931.63
2442500-44250081.41782.12
3446070-44607082.07482.78
4454165-45416583.56484.28
5446865-44686582.22082.93
6436173-43617380.25380.94
极限1461743-46174384.95884.001.1085.8384.841.10
2453741-45374183.48684.33
3454020-45402083.53784.38
4463693-46369385.31786.17
5454874-45487483.69484.54
6451104-45110483.00083.82
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%
1 15.174916554914044916464918594920844917300.06
2 15.124926074924254925160.03
单位质量响应值RSD%判断
32414.6332573.810.35数据可信
供试品溶液-2024122921批-pH1.2(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%
5min1262815-26281548.33448.537.3348.3348.537.33
2276615-27661550.87250.87
3265684-26568448.86248.86
4269046-26904649.48049.48
5227171-22717141.77941.78
6282006-28200651.86451.86
10min1354643-35464365.22364.992.7965.3065.072.79
2361529-36152966.48966.57
3355440-35544065.36965.45
4354250-35425065.15065.23
5334263-33426361.47561.54
6360085-36008566.22366.31
15min1384875-38487570.78370.650.7170.9770.830.72
2387630-38763071.28971.48
3384636-38463670.73970.93
4382478-38247870.34270.53
5379757-37975769.84170.01
6385434-38543470.88571.08
20min1400669-40066973.68773.480.4773.9973.790.48
2401704-40170473.87874.19
3398220-39822073.23773.55
4398781-39878173.34073.65
5396887-39688772.99273.28
6400982-40098273.74574.06
30min1417077-41707776.70576.660.5677.1377.080.57
2418565-41856576.97977.42
3415902-41590276.48976.92
4414355-41435576.20476.63
5414674-41467476.26376.67
6420330-42033077.30377.74
45min1430847-43084779.23779.220.3979.8079.780.40
2432319-43231979.50880.07
3428986-42898678.89579.45
4429780-42978079.04179.60
5429569-42956979.00279.54
6433155-43315579.66280.23
60min1433625-43362579.74879.890.5680.4480.580.56
2437646-43764680.48881.19
3433904-43390479.80080.49
4431139-43113979.29179.98
5433378-43337879.70380.37
6436775-43677580.32881.03
极限1444136-44413681.68181.350.4982.5082.170.49
2444279-44427981.70882.54
3442015-44201581.29182.11
4438745-43874580.69081.51
5441133-44113381.12981.93
6443620-44362081.58682.42
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