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%
110.153213463215493219543198383202593209890.28
210.173232513227543230020.11
单位质量响应值RSD%判断
31624.5331760.280.31数据可信
供试品溶液-JPS7149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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min151759-5175914.64014.583.6914.6414.583.69
252546-5254614.86214.86
350896-5089614.39614.40
454660-5466015.46015.46
549770-4977014.07714.08
649613-4961314.03314.03
15min166623-6662318.84418.932.3618.8718.952.37
268179-6817919.28419.31
365911-6591118.64318.67
469382-6938219.62419.65
565121-6512118.41918.44
666248-6624818.73818.76
20min177894-7789422.03222.372.5922.0922.432.59
280702-8070222.82622.88
378188-7818822.11522.17
482510-8251023.33823.40
577314-7731421.86821.92
678021-7802122.06822.12
30min197008-9700827.43827.792.1027.5327.882.10
299940-9994028.26828.36
396140-9614027.19327.28
4101319-10131928.65828.75
596543-9654327.30727.40
698536-9853627.87027.96
45min1119293-11929333.74134.101.7333.8834.241.73
2122483-12248334.64434.79
3118478-11847833.51133.65
4123405-12340534.90435.05
5118674-11867433.56633.70
6121066-12106634.24334.38
60min1137547-13754738.90439.201.4539.1039.391.45
2139871-13987139.56239.76
3136100-13610038.49538.69
4141532-14153240.03240.23
5137172-13717238.79838.99
6139278-13927839.39439.59
极限1185329-18532952.41952.801.2552.6853.071.25
2187708-18770853.09253.36
3183816-18381651.99152.25
4190634-19063453.92054.19
5186286-18628652.69052.95
6186373-18637352.71552.98
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%
110.154776184762644789824783114785594779470.23
210.174776364769494772920.11
单位质量响应值RSD%判断
47088.3746931.370.24数据可信
供试品溶液-JPS7664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%
5min135517-355176.7735.5749.156.775.5849.15
233636-336366.4146.41
335644-356446.7976.80
436685-366856.9957.00
533905-339056.4656.47
6-0.0000.00
10min164204-6420412.24312.587.4212.2512.597.41
266166-6616612.61712.63
375432-7543214.38414.39
464516-6451612.30212.31
564300-6430012.26112.27
661282-6128211.68511.69
15min182998-8299815.82616.508.9715.8616.538.97
286577-8657716.50916.54
3101780-10178019.40819.44
483562-8356215.93415.97
583990-8399016.01616.05
680148-8014815.28315.30
20min198336-9833618.75119.649.3918.8119.709.38
2102849-10284919.61219.67
3121954-12195423.25523.32
499619-9961918.99619.05
5100527-10052719.16919.23
694724-9472418.06218.11
30min1122606-12260623.37924.469.3923.4724.559.40
2127322-12732224.27824.37
3151981-15198128.98029.09
4124571-12457123.75423.84
5125126-12512623.86023.95
6117980-11798022.49722.57
45min1150433-15043328.68530.179.1528.8130.319.15
2158708-15870830.26330.40
3186352-18635235.53435.69
4154491-15449129.45929.59
5153956-15395629.35729.49
6145499-14549927.74427.86
60min1173323-17332333.05034.528.9333.2334.708.94
2181369-18136934.58434.77
3212466-21246640.51440.73
4176191-17619133.59733.78
5176309-17630933.61933.80
6166461-16646131.74131.90
极限1221928-22192842.31842.994.8242.5543.234.84
2229260-22926043.71643.96
3244701-24470146.66146.94
4223309-22330942.58142.82
5220828-22082842.10842.34
6212599-21259940.53940.75
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%
110.154742854753634739234764174759524751880.23
210.174766654764504765580.04
单位质量响应值RSD%判断
46816.5546859.190.07数据可信
供试品溶液-JPS7157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%
5min145708-457088.7489.737.488.759.737.47
249701-497019.5129.51
357326-5732610.97110.97
449475-494759.4699.47
551138-511389.7879.79
651636-516369.8829.88
10min175146-7514614.38215.134.9214.4015.154.92
277300-7730014.79414.81
386160-8616016.49016.51
476645-7664514.66914.68
579350-7935015.18615.20
679871-7987115.28615.30
15min195758-9575818.32719.103.7718.3719.143.77
299310-9931019.00619.05
3106632-10663220.40820.45
497080-9708018.58018.62
5100112-10011219.16019.20
699910-9991019.12119.16
20min1113314-11331421.68622.513.1221.7622.583.12
2117347-11734722.45822.53
3123824-12382423.69823.78
4114821-11482121.97522.05
5119063-11906322.78722.86
6117229-11722922.43622.51
30min1140783-14078326.94427.692.0227.0527.802.04
2145247-14524727.79827.91
3148807-14880728.47928.60
4142148-14214827.20527.31
5146595-14659528.05628.17
6144437-14443727.64327.75
45min1170818-17081832.69233.391.7632.8433.551.76
2175233-17523333.53733.69
3178394-17839434.14234.31
4171762-17176232.87233.03
5177420-17742033.95534.11
6173247-17324733.15733.31
60min1194019-19401937.13237.681.4337.3437.901.43
2198845-19884538.05638.27
3199528-19952838.18638.41
4193852-19385237.10037.31
5199778-19977838.23438.45
6195297-19529737.37737.59
极限1241629-24162946.24446.810.9746.5147.080.98
2247415-24741547.35147.63
3245816-24581647.04547.33
4241990-24199046.31346.58
5246190-24619047.11747.40
6244417-24441746.77747.05
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%
110.154798994770524792594775504797284786980.28
210.174748264775324761790.41
单位质量响应值RSD%判断
47162.3646821.930.52数据可信
供试品溶液-2024112221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%
5min1111917-11191721.34918.7214.4921.3518.7214.50
279944-7994415.25015.25
3111337-11133721.23821.24
490709-9070917.30317.30
5108801-10880120.75520.75
686032-8603216.41116.41
10min1173724-17372433.13931.853.6433.1731.883.64
2161846-16184630.87330.90
3172112-17211232.83232.87
4158509-15850930.23730.27
5170285-17028532.48332.52
6165230-16523031.51931.55
15min1205846-20584639.26739.041.2839.3639.121.28
2200310-20031038.21138.29
3206941-20694139.47639.57
4202756-20275638.67738.76
5205211-20521139.14639.23
6206742-20674239.43839.52
20min1227749-22774943.44543.570.9443.6043.720.94
2226433-22643343.19443.33
3229239-22923943.72943.89
4227019-22701943.30643.45
5227558-22755843.40843.56
6232288-23228844.31144.46
30min1253077-25307748.27648.690.7548.5148.910.75
2253060-25306048.27348.49
3255257-25525748.69248.92
4256594-25659448.94749.16
5255619-25561948.76148.99
6257866-25786649.19049.41
45min1276064-27606452.66152.920.4852.9753.220.47
2276016-27601652.65252.95
3277213-27721352.88153.19
4278712-27871253.16653.46
5277307-27730752.89853.21
6279215-27921553.26253.56
60min1287467-28746754.83755.290.6555.2355.680.64
2289307-28930755.18855.57
3288892-28889255.10855.51
4292945-29294555.88256.27
5289563-28956355.23655.63
6290854-29085455.48355.87
极限1299925-29992557.21357.470.3357.7057.950.33
2300849-30084957.38957.86
3301640-30164057.54058.03
4301787-30178757.56858.05
5300654-30065457.35257.84
6302738-30273857.75058.23
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