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 15.154803314799684801254804634796564801090.07
2 15.144803044801214802120.03
单位质量响应值RSD%判断
31690.3631718.100.07数据可信
供试品溶液-JPS8079批-pH4.5(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%
5min1474859-47485989.50789.700.3489.5189.700.34
2474660-47466089.47089.47
3474625-47462589.46389.46
4475187-47518789.56989.57
5477865-47786590.07490.07
6477958-47795890.09190.09
10min1475649-47564989.65689.130.6389.8189.280.63
2475538-47553889.63589.78
3473941-47394189.33489.48
4473550-47355089.26089.41
5469131-46913188.42888.58
6469259-46925988.45288.60
15min1-0.0000.00-0.300.300.00
2-0.0000.30
3-0.0000.30
4-0.0000.30
5-0.0000.30
6-0.0000.30
20min1-0.0000.00-0.300.300.00
2-0.0000.30
3-0.0000.30
4-0.0000.30
5-0.0000.30
6-0.0000.30
30min1-0.0000.00-0.300.300.00
2-0.0000.30
3-0.0000.30
4-0.0000.30
5-0.0000.30
6-0.0000.30
45min1-0.0000.00-0.300.300.00
2-0.0000.30
3-0.0000.30
4-0.0000.30
5-0.0000.30
6-0.0000.30
60min1-0.0000.00-0.300.300.00
2-0.0000.30
3-0.0000.30
4-0.0000.30
5-0.0000.30
6-0.0000.30
极限1-0.0000.00-0.300.300.00
2-0.0000.30
3-0.0000.30
4-0.0000.30
5-0.0000.30
6-0.0000.30
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 15.154787474792774799474787724783344790150.13
2 15.144813034818494815760.09
单位质量响应值RSD%判断
31618.1531808.190.43数据可信
供试品溶液-JPS7664批-pH4.5(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%
5min1408840-40884077.04275.202.5477.0475.202.54
2396679-39667974.75074.75
3405928-40592876.49376.49
4389044-38904473.31273.31
5408137-40813776.91076.91
6385621-38562172.66772.67
10min1483980-48398091.20289.273.1991.3389.403.19
2475366-47536689.57889.70
3487259-48725991.81991.95
4458893-45889386.47486.60
5485409-48540991.47191.60
6451574-45157485.09585.22
15min1506335-50633595.41493.653.0595.6993.923.05
2498276-49827693.89694.17
3510045-51004596.11396.39
4484760-48476091.34991.61
5509595-50959596.02896.31
6472926-47292689.11989.38
20min1517136-51713697.44995.663.0697.8996.083.06
2508295-50829595.78396.21
3521027-52102798.18398.62
4495294-49529493.33493.75
5520898-52089898.15898.60
6483065-48306591.02991.44
30min1526467-52646799.20897.363.0899.8197.953.07
2516944-51694497.41398.00
3531063-531063100.074100.68
4504312-50431295.03395.61
5529653-52965399.808100.41
6491493-49149392.61793.18
45min1530230-53023099.91797.992.97100.6898.742.97
2518945-51894597.79098.54
3533622-533622100.556101.33
4509118-50911895.93996.67
5532886-532886100.417101.19
6495189-49518993.31494.03
60min1531820-531820100.21798.063.17101.1598.983.17
2519728-51972897.93898.85
3533996-533996100.627101.57
4509084-50908495.93296.82
5534226-534226100.670101.61
6493491-49349192.99493.87
极限1530729-530729100.01198.043.01101.1199.123.01
2519051-51905197.81098.89
3533530-533530100.539101.65
4511278-51127896.34697.40
5533111-533111100.460101.57
6493961-49396193.08294.11
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 15.154804404815804806524806744811004808890.10
2 15.144849554832704841120.25
单位质量响应值RSD%判断
31741.8531975.690.52数据可信
供试品溶液-JPS8079批-pH4.5(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%
5min1362668-36266868.02968.451.4268.0368.451.42
2373600-37360070.08070.08
3367969-36796969.02469.02
4358795-35879567.30367.30
5363308-36330868.14968.15
6363127-36312768.11668.12
10min1435058-43505881.60881.960.4481.7282.070.44
2438715-43871582.29482.41
3435281-43528181.65081.77
4439409-43940982.42582.54
5437460-43746082.05982.17
6435553-43555381.70181.81
15min1453101-45310184.99385.840.6585.2486.090.65
2458557-45855786.01686.27
3456188-45618885.57285.82
4461861-46186186.63686.89
5458853-45885386.07286.32
6457046-45704685.73385.98
20min1462314-46231486.72187.520.7687.1187.910.76
2467509-46750987.69688.09
3464122-46412287.06087.45
4471721-47172188.48688.88
5469132-46913288.00088.39
6464603-46460387.15087.54
30min1474230-47423088.95689.220.6689.4989.760.65
2476631-47663189.40789.95
3474236-47423688.95789.50
4480844-48084490.19790.74
5476139-47613989.31489.85
6471678-47167888.47889.02
45min1478700-47870089.79590.211.0390.4890.901.03
2484007-48400790.79091.48
3477828-47782889.63190.32
4486991-48699191.35092.04
5484208-48420890.82891.52
6473843-47384388.88489.57
60min1482550-48255090.51790.701.0991.3591.541.09
2486268-48626891.21492.06
3480326-48032690.10090.94
4490831-49083192.07092.91
5485635-48563591.09691.94
6475686-47568689.22990.06
极限1489762-48976291.87092.401.2692.8593.401.26
2496050-49605093.04994.05
3486716-48671691.29892.29
4501757-50175794.12095.12
5495490-49549092.94493.94
6485905-48590591.14692.13
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 15.154837184828954832894821434829054829900.13
2 15.144865274846484855880.28
单位质量响应值RSD%判断
31880.5332073.180.43数据可信
供试品溶液-JPS8079批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1361604-36160467.57967.000.8767.5867.000.86
2361829-36182967.62167.62
3357875-35787566.88266.88
4353519-35351966.06866.07
5357325-35732566.77966.78
6359014-35901467.09567.09
10min1433975-43397581.10480.780.6881.2280.890.68
2429850-42985080.33380.45
3428829-42882980.14380.25
4430441-43044180.44480.55
5434138-43413881.13581.25
6436132-43613281.50781.62
15min1451689-45168984.41584.510.5784.6684.750.57
2448403-44840383.80184.05
3451238-45123884.33084.58
4451763-45176384.42984.67
5455824-45582485.18885.43
6454151-45415184.87585.12
20min1462487-46248786.43386.390.3286.8286.780.31
2459685-45968585.90986.30
3461483-46148386.24586.63
4463176-46317686.56286.95
5463167-46316786.56086.95
6463427-46342786.60887.00
30min1469876-46987687.81487.831.0188.3588.361.00
2464457-46445786.80187.33
3466677-46667787.21687.75
4468378-46837887.53488.06
5477628-47762889.26289.80
6472817-47281788.36388.90
45min1475660-47566088.89588.550.5589.5789.230.55
2474283-47428388.63789.31
3468693-46869387.59388.27
4474195-47419588.62189.30
5474939-47493988.76089.44
6475252-47525288.81889.50
60min1476476-47647689.04788.901.3489.8789.731.34
2470019-47001987.84088.66
3469540-46954087.75188.57
4472291-47229188.26589.09
5480220-48022089.74790.58
6485679-48567990.76791.60
极限1493025-49302592.14091.141.0693.1292.121.05
2482322-48232290.14091.11
3484953-48495390.63191.60
4482124-48212490.10391.07
5492650-49265092.07093.05
6491029-49102991.76792.75
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