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 15.174842304840964840574838804836984839920.05
2 15.124842674838574840620.06
单位质量响应值RSD%判断
31904.5532014.680.25数据可信
供试品溶液-JPS7157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%
5min1298206-29820655.76156.613.9055.7656.613.90
2324770-32477060.72860.73
3305924-30592457.20457.20
4291010-29101054.41554.41
5298231-29823155.76555.77
6298317-29831755.78155.78
10min1377260-37726070.54372.543.9970.6472.643.99
2415857-41585777.76077.86
3389541-38954172.83972.93
4370953-37095369.36369.45
5389089-38908972.75472.85
6385072-38507272.00372.10
15min1407825-40782576.25878.193.9276.4778.403.92
2448209-44820983.80984.04
3419104-41910478.36778.58
4400528-40052874.89375.10
5419256-41925678.39578.61
6413925-41392577.39877.61
20min1423316-42331679.15481.293.9679.4981.633.96
2465989-46598987.13487.50
3435356-43535681.40681.75
4415878-41587877.76478.09
5436569-43656981.63381.98
6431216-43121680.63280.97
30min1439720-43972082.22284.644.1182.6985.124.11
2486250-48625090.92291.44
3453455-45345584.79085.27
4432270-43227080.82981.29
5455013-45501385.08185.56
6449264-44926484.00684.48
45min1451691-45169184.46086.934.0985.0787.564.09
2499463-49946393.39394.06
3465923-46592387.12187.75
4444497-44449783.11583.71
5466808-46680887.28787.91
6461043-46104386.20986.83
60min1455599-45559985.19187.894.2685.9488.664.26
2505299-50529994.48495.31
3471861-47186188.23289.00
4446995-44699583.58284.32
5473180-47318088.47889.25
6467183-46718387.35788.12
极限1456835-45683585.42288.334.3386.3189.244.33
2507967-50796794.98395.96
3473513-47351388.54189.46
4448841-44884183.92784.80
5477006-47700689.19490.11
6470019-47001987.88788.79
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 15.174846034845454847204845714853054847490.07
2 15.124847214835644841420.17
单位质量响应值RSD%判断
31954.4532019.970.15数据可信
供试品溶液-JPS7664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%
5min1299961-29996156.04057.482.1556.0457.482.15
2317020-31702059.22759.23
3307373-30737357.42557.42
4305267-30526757.03157.03
5313863-31386358.63758.64
6302527-30252756.52056.52
10min1383731-38373171.69072.621.4771.7872.721.47
2397784-39778474.31674.41
3390119-39011972.88472.98
4382388-38238871.44071.53
5391610-39161073.16273.26
6386771-38677172.25872.35
15min1412654-41265477.09478.091.2977.3178.311.29
2426784-42678479.73479.96
3418961-41896178.27278.49
4412147-41214776.99977.21
5419728-41972878.41678.64
6417727-41772778.04278.26
20min1428325-42832580.02281.121.2780.3681.461.27
2443481-44348182.85383.21
3435006-43500681.27081.62
4428849-42884980.12080.46
5434915-43491581.25381.60
6434575-43457581.18981.53
30min1443506-44350682.85884.491.4083.3384.971.40
2460464-46046486.02686.52
3453441-45344184.71485.20
4446040-44604083.33183.81
5454726-45472684.95485.44
6455267-45526785.05585.54
45min1456203-45620385.23086.771.3485.8487.391.34
2473358-47335888.43589.07
3465559-46555986.97887.60
4458490-45849085.65786.27
5466339-46633987.12487.75
6466769-46676987.20487.83
60min1463525-46352586.59887.881.3787.3588.651.37
2480349-48034989.74190.53
3469933-46993387.79588.56
4463871-46387186.66387.42
5470110-47011087.82888.60
6474602-47460288.66789.43
极限1463190-46319086.53588.111.4887.4389.021.48
2481681-48168189.99090.92
3472157-47215788.21189.13
4464264-46426486.73687.64
5473015-47301588.37189.29
6475320-47532088.80289.72
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 15.174834984837104827554829344830304831850.09
2 15.124835444830394832920.08
单位质量响应值RSD%判断
31851.3531963.760.25数据可信
供试品溶液-JPS7157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%
5min1341973-34197364.04966.022.3264.0566.022.31
2358787-35878767.19867.20
3346486-34648664.89464.89
4347407-34740765.06665.07
5360800-36080067.57567.57
6359597-35959767.35067.35
10min1421638-42163878.96980.691.3179.0880.801.30
2434292-43429281.33981.45
3438102-43810282.05382.16
4428104-42810480.18080.29
5431377-43137780.79380.91
6431425-43142580.80280.91
15min1448576-44857684.01585.871.3484.2586.111.34
2462871-46287186.69286.94
3466240-46624087.32387.57
4455493-45549385.31085.55
5459328-45932886.02886.28
6458276-45827685.83186.08
20min1462985-46298586.71388.651.3487.0989.041.34
2478811-47881189.67790.07
3480646-48064690.02190.41
4470385-47038588.09988.48
5474249-47424988.82389.21
6473036-47303688.59688.99
30min1483018-48301890.46591.911.1390.9992.441.13
2496612-49661293.01193.55
3497071-49707193.09793.64
4486616-48661691.13991.67
5491146-49114691.98892.53
6489886-48988691.75292.29
45min1492131-49213192.17294.341.3392.8595.031.32
2507902-50790295.12695.82
3510842-51084295.67696.37
4500319-50031993.70694.39
5506239-50623994.81495.51
6504767-50476794.53995.23
60min1497448-49744893.16895.411.3994.0096.261.39
2516147-51614796.67097.53
3516540-51654096.74497.60
4506300-50630094.82695.66
5509708-50970895.46496.31
6510392-51039295.59296.44
极限1501188-50118893.86896.171.4594.8597.171.45
2520869-52086997.55498.57
3520833-52083397.54898.56
4509688-50968895.46096.46
5513453-51345396.16597.17
6514700-51470096.39997.41
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 15.174832654835524836244839504839844836750.07
2 15.124847094845994846540.02
单位质量响应值RSD%判断
31883.6532053.840.38数据可信
供试品溶液-JPS7664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%
5min1379809-37980970.99966.295.1171.0066.295.11
2367216-36721668.64568.65
3344628-34462864.42364.42
4327341-32734161.19161.19
5353780-35378066.13366.13
6355013-35501366.36466.36
10min1452516-45251684.59179.813.6584.7179.923.65
2439262-43926282.11382.23
3415377-41537777.64877.76
4412863-41286377.17877.28
5420438-42043878.59478.70
6421312-42131278.75778.87
15min1479631-47963189.65984.783.6689.9285.023.66
2468677-46867787.61287.86
3440071-44007182.26482.50
4440620-44062082.36782.60
5444845-44484583.15783.40
6447339-44733983.62383.86
20min1495169-49516992.56487.433.4692.9787.823.46
2479729-47972989.67890.07
3455498-45549885.14885.52
4455754-45575485.19685.56
5459640-45964085.92286.30
6460531-46053186.08986.47
30min1511656-51165695.64690.473.4096.2191.003.40
2496796-49679692.86893.41
3472427-47242788.31388.83
4472264-47226488.28288.79
5475248-47524888.84089.36
6475434-47543488.87589.40
45min1525500-52550098.23492.863.4198.9693.543.42
2509271-50927195.20095.90
3484005-48400590.47791.14
4484080-48408090.49191.15
5488196-48819691.26091.93
6489409-48940991.48792.16
60min1532587-53258799.55993.973.55100.4494.803.55
2516689-51668996.58797.45
3489470-48947091.49992.31
4490523-49052391.69592.50
5492681-49268192.09992.92
6494193-49419392.38193.21
极限1536365-536365100.26594.693.53101.3295.683.53
2520828-52082897.36098.38
3492559-49255992.07693.04
4494960-49496092.52593.49
5497407-49740792.98293.96
6497091-49709192.92393.90
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