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%
110.323306173306583303983301193302653304110.07
210.243304183300673302420.08
单位质量响应值RSD%判断
32016.5732250.200.52数据可信
供试品溶液-2024122521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%
5min1214133-21413359.73665.154.5159.7465.154.51
2238528-23852866.54166.54
3238471-23847166.52566.53
4238729-23872966.59766.60
5228890-22889063.85363.85
6242430-24243067.63067.63
10min1284781-28478179.44483.452.8479.5483.562.84
2306630-30663085.53985.65
3296184-29618482.62582.74
4301924-30192484.22784.34
5297352-29735282.95183.06
6307936-30793685.90486.02
15min1306579-30657985.52588.211.7985.7688.461.80
2322381-32238189.93390.19
3314008-31400887.59887.85
4316624-31662488.32788.58
5316480-31648088.28788.53
6321084-32108489.57189.83
20min1314006-31400687.59790.101.7787.9790.491.78
2329658-32965891.96392.37
3322307-32230789.91390.31
4324351-32435190.48390.88
5319555-31955589.14589.54
6327900-32790091.47391.88
30min1322355-32235589.92692.271.7190.4592.821.72
2336489-33648993.86994.43
3327617-32761791.39491.94
4332942-33294292.87993.43
5328376-32837691.60692.15
6336771-33677193.94894.51
45min1327254-32725491.29393.191.5891.9693.891.58
2340338-34033894.94395.66
3332112-33211292.64893.34
4338765-33876594.50495.21
5329529-32952991.92792.62
6336427-33642793.85294.57
60min1328891-32889191.74993.881.6092.5794.741.61
2342278-34227895.48496.36
3334969-33496993.44594.30
4341252-34125295.19896.06
5332173-33217392.66593.51
6339608-33960894.73995.61
极限1345962-34596296.51296.121.2097.4997.131.18
2342356-34235695.50696.54
3351848-35184898.15499.16
4344960-34496096.23297.25
5340601-34060195.01696.02
6341637-34163795.30596.33
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%
110.323305323308703311743312523306763309010.10
210.243301533303993302760.06
单位质量响应值RSD%判断
32064.0532253.520.42数据可信
供试品溶液-2024122621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%
5min1218744-21874460.97466.037.2060.9766.037.20
2262912-26291273.28573.29
3249886-24988669.65469.65
4236725-23672565.98665.99
5231952-23195264.65564.66
6221018-22101861.60861.61
10min1294275-29427582.02785.512.3482.1385.622.34
2313952-31395287.51287.63
3311119-31111986.72386.84
4306651-30665185.47785.59
5303510-30351084.60284.71
6311204-31120486.74686.85
15min1311988-31198886.96590.182.2187.2090.442.21
2329314-32931491.79492.06
3325715-32571590.79191.05
4325113-32511390.62390.88
5318262-31826288.71488.96
6330818-33081892.21492.46
20min1320985-32098589.47392.872.1289.8693.272.13
2338586-33858694.37994.80
3334745-33474593.30893.72
4336135-33613593.69694.10
5328919-32891991.68492.08
6339658-33965894.67895.08
30min1329130-32913091.74395.062.2692.2895.622.26
2350688-35068897.75298.33
3341535-34153595.20195.77
4342812-34281295.55796.12
5335605-33560593.54894.10
6346359-34635996.54697.10
45min1332817-33281792.77196.002.0093.4696.722.01
2350504-35050497.70198.44
3346634-34663496.62297.35
4347661-34766196.90997.63
5339369-33936994.59795.30
6349383-34938397.38998.11
60min1334632-33463293.27796.531.9894.1297.411.98
2350454-35045497.68798.59
3350827-35082797.79198.68
4349064-34906497.30098.18
5341368-34136895.15496.02
6351554-35155497.99498.88
极限1350218-35021897.62197.641.0398.6298.681.03
2353311-35331198.48399.55
3349894-34989497.53198.58
4351737-35173798.04599.09
5343555-34355595.76496.79
6352973-35297398.38999.43
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%
110.323306793298453300023295253302483300600.14
210.243300193301213300700.03
单位质量响应值RSD%判断
31982.5632233.400.56数据可信
供试品溶液-2024122721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%
5min1242526-24252667.71065.473.5467.7165.483.53
2238540-23854066.59766.60
3226143-22614363.13663.14
4222173-22217362.02862.03
5239910-23991066.98066.98
6237806-23780666.39266.39
10min1313743-31374387.59387.301.1687.7187.411.16
2310435-31043586.66986.78
3310035-31003586.55886.66
4311879-31187987.07387.18
5310598-31059886.71586.83
6319525-31952589.20789.32
15min1333030-33303092.97892.730.9793.2492.990.97
2332368-33236892.79393.05
3331318-33131892.50092.75
4331078-33107892.43392.68
5327642-32764291.47391.73
6337514-33751494.23094.49
20min1341101-34110195.23194.631.3295.6495.031.32
2334998-33499893.52793.94
3338686-33868694.55794.96
4337471-33747194.21894.62
5334700-33470093.44493.85
6346626-34662696.77497.19
30min1351686-35168698.18697.191.2198.7697.761.21
2349962-34996297.70598.27
3346851-34685196.83697.40
4344392-34439296.15096.71
5342546-34254695.63496.20
6353211-35321198.61299.19
45min1353740-35374098.76097.751.2099.5098.481.20
2345005-34500596.32197.05
3350218-35021897.77698.50
4349069-34906997.45698.18
5346690-34669096.79197.52
6356057-35605799.407100.15
60min1355340-35534099.20698.261.16100.1199.151.15
2347198-34719896.93397.82
3352075-35207598.29599.18
4350956-35095697.98298.86
5348344-34834497.25398.14
6357767-35776799.884100.79
极限1357583-35758399.83398.721.19100.9099.771.18
2348665-34866597.34398.39
3353033-35303398.56299.61
4353011-35301198.55699.60
5349918-34991897.69398.74
6359321-359321100.318101.39
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