利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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800
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%
112.044811354817304818034818554816194816280.07
212.064828574819194823880.14
单位质量响应值RSD%判断
40002.3339999.000.01数据可信
供试品溶液-2024010911批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154477-15447728.84826.467.6828.8526.467.69
2152120-15212028.40828.41
3143430-14343026.78526.79
4141061-14106126.34326.34
5132595-13259524.76224.76
6126431-12643123.61123.61
10min1194668-19466836.35435.073.0036.4235.133.00
2184687-18468734.49034.55
3190739-19073935.62035.68
4192635-19263535.97436.03
5180955-18095533.79333.85
6183110-18311034.19534.25
15min1219210-21921040.93739.981.9141.0840.121.92
2214708-21470840.09640.24
3213441-21344139.85940.00
4216375-21637540.40740.55
5213774-21377439.92240.05
6206930-20693038.64438.77
20min1241972-24197245.18843.422.0645.4243.642.07
2232189-23218943.36143.59
3230991-23099143.13743.36
4230540-23054043.05343.28
5228462-22846242.66542.88
6230935-23093543.12643.34
30min1247366-24736646.19546.962.9846.5347.282.98
2258425-25842548.26048.59
3257424-25742448.07348.40
4258310-25831048.23948.56
5245945-24594545.92946.24
6241362-24136245.07445.38
45min1269132-26913250.26049.172.6950.7049.602.69
2267085-26708549.87750.31
3262480-26248049.01749.45
4270622-27062250.53850.97
5258078-25807848.19548.61
6252352-25235247.12647.54
60min1262765-26276549.07149.432.0249.6249.972.02
2266259-26625949.72350.27
3262494-26249449.02049.56
4274522-27452251.26651.81
5263231-26323149.15849.68
6258931-25893148.35548.87
极限1268850-26885050.20750.740.8950.8751.390.86
2272588-27258850.90551.56
3268643-26864350.16850.82
4273788-27378851.12951.79
5272196-27219650.83251.46
6274161-27416151.19951.82
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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800
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%
112.044816094817234815444818794816514816810.03
212.064832844831054831940.03
单位质量响应值RSD%判断
40006.7340065.840.11数据可信
供试品溶液-2024010911批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154261-15426128.78226.407.6528.7826.407.65
2151567-15156728.28028.28
3143319-14331926.74126.74
4141125-14112526.33126.33
5132341-13234124.69224.69
6126218-12621823.55023.55
10min1195111-19511136.40435.092.9136.4735.152.91
2182306-18230634.01534.08
3183102-18310234.16334.22
4192583-19258335.93235.99
5184385-18438534.40334.46
6190898-19089835.61835.67
15min1218264-21826440.72439.781.8440.8739.921.84
2211339-21133939.43239.57
3212675-21267539.68139.82
4206903-20690338.60438.74
5214429-21442940.00840.14
6215661-21566140.23840.37
20min1233927-23392743.64642.861.0043.8843.081.01
2228084-22808442.55642.78
3228763-22876342.68342.91
4229644-22964442.84743.07
5230289-23028942.96843.19
6227549-22754942.45642.68
30min1246692-24669246.02845.631.5246.3645.951.50
2247025-24702546.09046.41
3245259-24525945.76146.08
4237195-23719544.25644.58
5244941-24494145.70146.02
6246198-24619845.93646.25
45min1256677-25667747.89147.840.8848.3348.260.87
2258606-25860648.25148.67
3252251-25225147.06547.49
4258056-25805648.14848.57
5256773-25677347.90948.33
6256058-25605847.77648.19
60min1260744-26074448.65048.850.9749.1949.380.96
2262550-26255048.98749.52
3262501-26250148.97849.50
4257219-25721947.99248.52
5264078-26407849.27249.80
6263728-26372849.20749.73
极限1267118-26711849.83949.840.6650.4950.470.64
2263790-26379049.21849.86
3266952-26695249.80850.44
4268322-26832250.06450.70
5267904-26790449.98650.62
6268520-26852050.10150.73
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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800
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%
112.044830904830334829694826174828784829170.04
212.064846714914704880700.99
单位质量响应值RSD%判断
40109.3940470.150.64数据可信
供试品溶液-JPS5451批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189576-18957635.14932.9312.8135.1532.9312.80
2186498-18649834.57934.58
3183319-18331933.98933.99
4186232-18623234.52934.53
5188657-18865734.97934.98
6131414-13141424.36624.37
10min1226479-22647941.99241.780.4042.0741.850.39
2224867-22486741.69341.77
3223879-22387941.51041.59
4225387-22538741.78941.87
5225369-22536941.78641.86
6225939-22593941.89141.95
15min1243958-24395845.23245.100.3345.4045.260.33
2243212-24321245.09445.26
3241695-24169544.81344.98
4243471-24347145.14245.31
5243581-24358145.16245.33
6243436-24343645.13645.28
20min1251877-25187746.70146.590.3146.9746.860.32
2250278-25027846.40446.67
3250458-25045846.43846.70
4252072-25207246.73747.01
5251859-25185946.69746.97
6251160-25116046.56846.82
30min1260501-26050148.30048.180.3248.6848.550.32
2258524-25852447.93348.31
3259465-25946548.10848.48
4260660-26066048.32948.70
5260382-26038248.27848.65
6259522-25952248.11848.47
45min1267363-26736349.57249.071.6850.0549.541.68
2265082-26508249.14949.63
3266235-26623549.36349.84
4266897-26689749.48649.97
5266533-26653349.41849.90
6255741-25574147.41747.88
60min1267706-26770649.63649.470.6550.2350.050.66
2266078-26607849.33449.92
3266988-26698849.50250.09
4267715-26771549.63750.23
5268516-26851649.78650.38
6263730-26373048.89849.46
极限1271986-27198650.42950.400.5651.1351.100.53
2269795-26979550.02350.72
3271157-27115750.27550.97
4271611-27161150.36051.06
5272138-27213850.45751.16
6274367-27436750.87151.54
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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800
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%
112.044855644859124853064853834847594853850.09
212.064879814877094878450.04
单位质量响应值RSD%判断
40314.3740451.490.25数据可信
供试品溶液-JPS5451批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1196255-19625536.30333.2616.9536.3033.2616.95
2190726-19072635.28035.28
3173109-17310932.02232.02
4200876-20087637.15837.16
5197055-19705536.45136.45
6120915-12091522.36722.37
10min1231191-23119142.76641.992.7842.8542.062.78
2226224-22622441.84741.93
3215082-21508239.78639.86
4232091-23209142.93243.01
5230477-23047742.63442.71
6226972-22697241.98542.03
15min1247722-24772245.82445.201.7046.0045.371.71
2242128-24212844.78944.96
3236962-23696243.83343.99
4247149-24714945.71845.90
5246786-24678645.65045.83
6245306-24530645.37745.52
20min1254939-25493947.15946.901.0647.4447.171.07
2252370-25237046.68346.95
3248586-24858645.98346.24
4255611-25561147.28347.56
5255072-25507247.18347.46
6254754-25475447.12447.37
30min1262740-26274048.60248.400.7348.9848.770.74
2260789-26078948.24148.62
3259301-25930147.96548.32
4264773-26477348.97849.36
5260773-26077348.23848.62
6261583-26158348.38848.74
45min1267556-26755649.49249.450.2649.9849.920.25
2266151-26615149.23349.71
3267200-26720049.42749.89
4267971-26797149.56950.06
5267064-26706449.40149.89
6267907-26790749.55750.01
60min1269586-26958649.86849.840.2650.4750.430.26
2268121-26812149.59750.19
3269871-26987149.92150.50
4269882-26988249.92350.53
5269249-26924949.80650.40
6269935-26993549.93250.50
极限1271482-27148250.21950.320.2850.9351.020.28
2271004-27100450.13050.83
3273022-27302250.50451.19
4272731-27273150.45051.16
5272013-27201350.31751.03
6271851-27185150.28750.96
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