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 14.994741714755944756654743454751904749930.15
2 15.034754914749594752250.08
单位质量响应值RSD%判断
31687.3231618.430.16数据可信
供试品溶液-JPS7837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%
5min144136-441368.3338.251.628.338.261.62
243834-438348.2768.28
343832-438328.2758.28
442829-428298.0868.09
544683-446838.4368.44
642964-429648.1128.11
10min183185-8318515.70515.302.0315.7215.312.03
281881-8188115.45915.47
381620-8162015.41015.42
479312-7931214.97414.99
581264-8126415.34215.36
678841-7884114.88514.90
15min1107160-10716020.23220.131.6220.2720.171.61
2107891-10789120.37020.41
3107550-10755020.30520.34
4105970-10597020.00720.05
5107725-10772520.33820.38
6103399-10339919.52219.56
20min1130222-13022224.58623.992.0524.6624.062.05
2127860-12786024.14024.21
3127984-12798424.16324.24
4126497-12649723.88223.95
5127342-12734224.04224.12
6122396-12239623.10823.18
30min1157561-15756129.74729.441.6629.8629.551.66
2156770-15677029.59829.71
3157292-15729229.69629.81
4156023-15602329.45729.57
5157063-15706329.65329.77
6150767-15076728.46528.57
45min1188253-18825335.54235.360.9435.7135.530.95
2187733-18773335.44435.61
3188418-18841835.57335.74
4187465-18746535.39335.55
5188157-18815735.52435.69
6183809-18380934.70334.86
60min1211172-21117239.86939.711.3640.0939.921.36
2210679-21067939.77640.00
3213344-21334440.27940.50
4210827-21082739.80440.02
5210976-21097639.83240.05
6204871-20487138.67938.89
极限1247904-24790446.80446.870.8347.0947.160.83
2249396-24939647.08647.37
3248652-24865246.94547.23
4249673-24967347.13847.42
5249651-24965147.13447.42
6244339-24433946.13146.41
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 14.994750144744264752834753884743484748920.11
2 15.034725614725304725460.01
单位质量响应值RSD%判断
31680.5931440.190.54数据可信
供试品溶液-JPS7837批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153588-15358829.08329.785.6729.0829.785.67
2169345-16934532.06632.07
3158373-15837329.98929.99
4159620-15962030.22530.22
5142354-14235426.95526.96
6160207-16020730.33630.34
10min1212734-21273440.28240.072.7740.3340.122.78
2219118-21911841.49141.54
3209855-20985539.73739.79
4212254-21225440.19140.24
5201421-20142138.14038.18
6214206-21420640.56140.61
15min1238765-23876545.21144.791.8645.3344.911.86
2241736-24173645.77445.90
3235360-23536044.56644.68
4236203-23620344.72644.84
5228873-22887343.33843.45
6238445-23844545.15145.27
20min1253366-25336647.97647.801.5348.1747.991.53
2254822-25482248.25248.45
3251779-25177947.67547.87
4255498-25549848.38048.57
5245045-24504546.40046.58
6254104-25410448.11648.31
30min1269985-26998551.12350.870.9151.3951.140.92
2271140-27114051.34151.62
3268374-26837450.81851.09
4269187-26918750.97251.24
5264083-26408350.00550.26
6269038-26903850.94351.22
45min1284173-28417353.80953.510.7554.1753.860.76
2283178-28317853.62153.99
3282417-28241753.47753.83
4283792-28379253.73754.09
5278428-27842852.72153.06
6283461-28346153.67454.03
60min1290021-29002154.91754.690.5655.3655.140.57
2288337-28833754.59855.05
3289678-28967854.85255.30
4289404-28940454.80055.25
5285755-28575554.10954.54
6289731-28973154.86255.31
极限1295633-29563355.97955.940.7156.5256.480.70
2293505-29350555.57656.12
3294978-29497855.85556.39
4298460-29846056.51557.05
5297017-29701756.24156.76
6292957-29295755.47356.01
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 14.994745194745094742484744314738544743120.06
2 15.034749564748814749180.02
单位质量响应值RSD%判断
31641.8931598.000.10数据可信
供试品溶液-JPS7837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%
5min152312-523129.88710.084.869.8910.084.86
249105-491059.2819.28
353932-5393210.19310.19
456896-5689610.75310.75
553179-5317910.05110.05
654596-5459610.31810.32
10min192428-9242817.46817.613.3217.4817.633.33
287754-8775416.58516.60
394680-9468017.89417.91
497032-9703218.33918.36
593336-9333617.64017.66
693954-9395417.75717.77
15min1118992-11899222.48922.634.0022.5322.674.00
2112881-11288121.33421.38
3121499-12149922.96323.01
4124784-12478423.58423.63
5115764-11576421.87921.92
6124477-12447723.52523.57
20min1138500-13850026.17626.223.0126.2626.303.01
2132776-13277625.09425.17
3141137-14113726.67426.76
4144298-14429827.27227.36
5135275-13527525.56625.65
6140364-14036426.52826.61
30min1165545-16554531.28731.372.5731.4131.502.57
2160304-16030430.29730.42
3169107-16910731.96032.09
4171553-17155332.42332.56
5162075-16207530.63130.76
6167420-16742031.64131.77
45min1193845-19384536.63636.712.2536.8136.882.25
2188931-18893135.70735.88
3197408-19740837.30937.49
4199491-19949137.70337.89
5189259-18925935.76935.95
6196344-19634437.10837.29
60min1214797-21479740.59540.521.6740.8440.761.68
2209636-20963639.62039.85
3216747-21674740.96441.21
4218781-21878141.34841.60
5210623-21062339.80740.04
6215689-21568940.76441.01
极限1244603-24460346.22946.271.0746.5446.581.08
2243217-24321745.96746.26
3246325-24632546.55446.87
4248290-24829046.92547.24
5240807-24080745.51145.81
6245672-24567246.43146.74
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 14.994779384778374761134777084767834772760.17
2 15.034773324763074768200.16
单位质量响应值RSD%判断
31839.6331724.550.26数据可信
供试品溶液-JPS7837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%
5min1393342-39334273.96174.912.7373.9674.912.73
2389988-38998873.33073.33
3402799-40279975.73975.74
4395720-39572074.40874.41
5390151-39015173.36173.36
6418400-41840078.67278.67
10min1476052-47605289.51390.121.5189.6490.251.51
2467953-46795387.99088.11
3486851-48685191.54391.67
4481693-48169390.57390.70
5476763-47676389.64689.77
6486466-48646691.47191.60
15min1500417-50041794.09494.861.8694.3795.131.86
2493157-49315792.72993.00
3515601-51560196.94997.23
4514496-51449696.74197.02
5496476-49647693.35393.62
6506727-50672795.28095.56
20min1514084-51408496.66496.901.6697.0997.341.66
2503229-50322994.62395.05
3525009-52500998.71899.16
4523937-52393798.51698.95
5508608-50860895.63496.06
6517260-51726097.26197.70
30min1522844-52284498.31199.181.6098.9099.781.60
2519712-51971297.72298.30
3538425-538425101.241101.85
4536203-536203100.823101.42
5518925-51892597.57498.16
6528733-52873399.418100.02
45min1526144-52614498.93199.631.7199.69100.391.71
2519106-51910697.60898.35
3539021-539021101.353102.13
4541467-541467101.813102.58
5522326-52232698.21498.96
6531157-53115799.874100.64
60min1529759-52975999.61199.891.64100.53100.821.64
2521419-52141998.04398.95
3539695-539695101.479102.42
4542182-542182101.947102.89
5521911-52191198.13599.05
6532449-532449100.117101.05
极限1529566-52956699.575100.101.75100.66101.201.75
2518962-51896297.58198.65
3541050-541050101.734102.85
4543696-543696102.232103.34
5526424-52642498.984100.06
6534516-534516100.506101.61
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