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%
19.983257473256033258193253923256113256340.06
210.043246083248443247260.06
单位质量响应值RSD%判断
32628.6632343.230.63数据可信
长期6月-供试品溶液-2024010511批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1196912-19691254.33665.3813.8254.3465.3813.82
2250107-25010769.01569.01
3241469-24146966.63166.63
4269764-26976474.43974.44
5196810-19681054.30854.31
6266469-26646973.52973.53
10min1268684-26868474.14179.006.5974.2679.146.61
2290616-29061680.19380.35
3293213-29321380.90981.06
4297708-29770882.15082.31
5258695-25869571.38471.50
6308843-30884385.22285.39
15min1296748-29674881.88585.643.9082.1785.963.93
2314879-31487986.88887.22
3313321-31332186.45886.79
4315179-31517986.97187.32
5295320-29532081.49181.77
6326748-32674890.16390.52
20min1313430-31343086.48889.352.4886.9689.862.50
2328190-32819090.56191.09
3323355-32335589.22789.75
4326443-32644390.07990.62
5316175-31617587.24587.71
6335120-33512092.47393.03
30min1326919-32691990.21092.731.7790.8793.441.79
2339005-33900593.54594.27
3331644-33164491.51492.23
4339407-33940793.65694.40
5336065-33606592.73493.39
6343371-34337194.75095.51
45min1332949-33294991.87494.561.8392.7395.481.85
2345500-34550095.33796.27
3337674-33767493.17894.10
4347667-34766795.93596.88
5343148-34314894.68895.55
6349268-34926896.37797.35
60min1334894-33489492.41195.051.9393.4796.171.94
2346840-34684095.70796.85
3337764-33776493.20394.33
4349048-34904896.31697.48
5346446-34644695.59896.67
6351667-35166797.03998.22
极限1334612-33461292.33395.191.9093.6096.531.91
2349364-34936496.40497.76
3340403-34040393.93195.27
4345606-34560695.36796.74
5347042-34704295.76397.05
6352824-35282497.35898.76
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%
19.983260413259473259913251283243413254900.23
210.043256003254373255180.04
单位质量响应值RSD%判断
32614.2332422.110.42数据可信
长期6月-供试品溶液-2024010611批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1216729-21672959.74463.096.5659.7463.096.56
2213438-21343858.83758.84
3219625-21962560.54360.54
4248654-24865468.54568.54
5245115-24511567.56967.57
6229591-22959163.29063.29
10min1284772-28477278.50180.243.5878.6380.383.59
2279157-27915776.95377.08
3281869-28186977.70177.84
4303475-30347583.65783.81
5300628-30062882.87283.02
6296571-29657181.75481.89
15min1313688-31368886.47287.261.7086.7887.581.71
2312551-31255186.15986.46
3309603-30960385.34685.65
4322849-32284988.99889.34
5321683-32168388.67689.01
6318927-31892787.91788.24
20min1328757-32875790.62690.760.8691.1391.280.87
2329805-32980590.91591.41
3323887-32388789.28489.78
4331631-33163191.41991.95
5331303-33130391.32891.86
6330150-33015091.01091.53
30min1342294-34229494.35894.210.6295.0694.920.63
2343934-34393494.81095.51
3337665-33766593.08293.78
4342077-34207794.29895.04
5342200-34220094.33295.07
6342349-34234994.37395.09
45min1347305-34730595.73995.630.7396.6596.560.72
2350697-35069796.67497.58
3342893-34289394.52395.43
4347531-34753195.80296.75
5346831-34683195.60996.55
6346228-34622895.44296.37
60min1351752-35175296.96596.280.8098.0997.410.79
2352358-35235897.13298.25
3344656-34465695.00996.12
4348464-34846496.05997.22
5348455-34845596.05697.21
6349868-34986896.44697.59
极限1351394-35139496.86796.540.7198.2197.890.70
2354124-35412497.61998.96
3346727-34672795.58096.90
4349145-34914596.24797.62
5349538-34953896.35597.72
6350266-35026696.55697.91
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%
19.983262783267543262123264473264863264350.07
210.043264583266543265560.05
单位质量响应值RSD%判断
32708.9232525.500.40数据可信
加速6月-供试品溶液-2024010511批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227007-22700762.38863.168.6362.3963.168.63
2258459-25845971.03171.03
3249176-24917668.48068.48
4208461-20846157.29157.29
5214582-21458258.97358.97
6221210-22121060.79460.79
10min1285366-28536678.42679.483.7478.5679.623.75
2301962-30196282.98783.14
3299055-29905582.18882.34
4275610-27561075.74575.87
5279163-27916376.72176.85
6294070-29407080.81880.95
15min1310940-31094085.45586.101.9285.7786.421.93
2319476-31947687.80088.14
3318053-31805387.40987.74
4305630-30563083.99584.29
5307672-30767284.55684.86
6318061-31806187.41287.73
20min1325734-32573489.52089.490.8290.0290.000.84
2327712-32771290.06490.60
3326705-32670589.78790.32
4322682-32268288.68289.16
5322221-32222188.55589.04
6328717-32871790.34090.85
30min1336103-33610392.37092.250.8593.0792.960.85
2334786-33478692.00892.75
3338145-33814592.93193.66
4335924-33592492.32193.00
5330609-33060990.86091.55
6338441-33844193.01393.72
45min1341246-34124693.78393.540.4594.6994.450.43
2338854-33885493.12694.07
3339111-33911193.19794.13
4342369-34236994.09294.98
5339110-33911093.19694.08
6341472-34147293.84694.76
60min1343198-34319894.32093.830.5495.4494.950.52
2339296-33929693.24894.40
3340223-34022393.50294.64
4342969-34296994.25795.35
5339809-33980993.38894.48
6343012-34301294.26995.39
极限1346876-34687695.33194.370.8296.6695.700.80
2341833-34183393.94595.30
3340266-34026693.51494.86
4345995-34599595.08996.39
5340847-34084793.67494.98
6344463-34446394.66896.00
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%
19.983255523256153256603259763254493256500.07
210.043253243253573253400.01
单位质量响应值RSD%判断
32630.2632404.380.50数据可信
加速6月-供试品溶液-2024010611批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1244669-24466967.44867.402.5767.4567.402.58
2244820-24482067.49067.49
3236094-23609465.08465.08
4252649-25264969.64869.65
5249885-24988568.88668.89
6238950-23895065.87265.87
10min1301105-30110583.00683.631.1283.1683.781.12
2302202-30220283.30983.46
3299829-29982982.65482.80
4306969-30696984.62384.78
5308168-30816884.95385.11
6301995-30199583.25283.40
15min1325205-32520589.65089.500.6889.9889.830.68
2320947-32094788.47688.81
3323900-32390089.29089.62
4324837-32483789.54889.89
5327706-32770690.33990.68
6325284-32528489.67290.00
20min1333578-33357891.95892.240.8292.4992.780.82
2330995-33099591.24691.78
3334756-33475692.28392.81
4332985-33298591.79592.34
5338582-33858293.33893.88
6336753-33675392.83393.36
30min1341419-34141994.12094.790.8194.8695.530.81
2341339-34133994.09894.83
3344944-34494495.09195.82
4341522-34152294.14894.89
5347114-34711495.69096.44
6346836-34683695.61396.35
45min1347462-34746295.78596.110.9696.7397.060.95
2345092-34509295.13296.08
3349091-34909196.23597.18
4345285-34528595.18596.14
5352181-35218197.08698.05
6352805-35280597.25898.21
60min1347317-34731795.74596.381.1096.9197.541.09
2344985-34498595.10396.26
3350767-35076796.69797.85
4346786-34678695.59996.77
5354202-35420297.64398.82
6353585-35358597.47398.64
极限1348093-34809395.95996.510.9497.3397.880.93
2347719-34771995.85697.22
3349620-34962096.38097.75
4346813-34681395.60796.99
5353896-35389697.55998.95
6354339-35433997.68199.06
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