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%
112.134856554858794859384851854854744856260.07
212.034887054883034885040.06
单位质量响应值RSD%判断
40035.1240607.151.01数据可信
供试品溶液-2024010711批-pH6.8(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%
5min1301897-30189755.93356.677.6155.9356.677.61
2348272-34827264.52564.53
3314815-31481558.32658.33
4295428-29542854.73554.73
5290616-29061653.84353.84
6284231-28423152.66052.66
10min1387289-38728971.75472.604.2371.8872.724.24
2413647-41364776.63776.78
3405017-40501775.03875.17
4397860-39786073.71273.83
5372067-37206768.93469.05
6375206-37520669.51569.63
15min1425410-42541078.81779.012.9079.1079.302.90
2440656-44065681.64181.95
3434417-43441780.48580.78
4433813-43381380.37380.66
5407882-40788275.56975.84
6416676-41667677.19877.47
20min1446059-44605982.64282.542.2683.1083.012.26
2455585-45558584.40784.90
3452617-45261783.85784.33
4451108-45110883.57884.04
5428880-42888079.45979.90
6438934-43893481.32281.77
30min1465271-46527186.20286.201.6886.8486.851.69
2471681-47168187.38988.07
3470676-47067687.20387.86
4471232-47123287.30687.96
5451854-45185483.71684.33
6460998-46099885.41086.03
45min1480378-48037889.00189.111.7889.8389.941.79
2486873-48687390.20491.08
3486248-48624890.08890.94
4488582-48858290.52191.36
5465631-46563186.26887.07
6478048-47804888.56989.38
60min1484368-48436889.74090.031.8290.7791.061.82
2489865-48986590.75891.84
3492351-49235191.21992.27
4494611-49461191.63892.68
5470073-47007387.09188.09
6484248-48424889.71890.73
极限1489180-48918090.63191.141.6491.8692.381.65
2495387-49538791.78193.06
3497584-49758492.18893.45
4501650-50165092.94294.19
5478953-47895388.73789.93
6488946-48894690.58891.80
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%
112.134843914848494845744843414847764845860.05
212.034844584842084843330.04
单位质量响应值RSD%判断
39949.3840260.430.55数据可信
供试品溶液-2024010811批-pH6.8(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%
5min1310226-31022657.78458.802.6857.7858.802.69
2326753-32675360.86260.86
3325328-32532860.59760.60
4310589-31058957.85257.85
5306455-30645557.08257.08
6314648-31464858.60858.61
10min1400252-40025274.55374.371.3174.6874.501.31
2408170-40817076.02776.16
3401170-40117074.72474.86
4394408-39440873.46473.59
5394116-39411673.41073.54
6397668-39766874.07174.20
15min1442541-44254182.43080.982.4182.7281.282.40
2443534-44353482.61582.92
3441622-44162282.25882.56
4416626-41662677.60377.89
5429129-42912979.93180.22
6435243-43524381.07081.37
20min1468053-46805387.18285.511.5487.6685.991.54
2462610-46261086.16886.66
3464754-46475486.56787.05
4453502-45350284.47184.94
5450287-45028783.87284.34
6455331-45533184.81285.29
30min1499544-49954493.04789.532.7393.7290.202.73
2485749-48574990.47891.16
3488195-48819590.93391.61
4470822-47082287.69788.35
5463107-46310786.26086.91
6476694-47669488.79189.45
45min1512918-51291895.53892.512.4796.4293.372.45
2495789-49578992.34893.23
3503497-50349793.78494.66
4502208-50220893.54394.39
5479993-47999389.40690.25
6485412-48541290.41591.28
60min1522040-52204097.23793.653.0398.3394.723.01
2502755-50275593.64594.73
3511906-51190695.35096.44
4508669-50866994.74795.80
5479333-47933389.28390.33
6492038-49203891.64992.71
极限1525064-52506497.80194.243.1699.1195.523.14
2506329-50632994.31195.60
3515524-51552496.02497.32
4513619-51361995.66996.93
5481011-48101189.59590.84
6494118-49411892.03793.30
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%
112.134877634879134870914860924850004867720.26
212.034896154894384895260.03
单位质量响应值RSD%判断
40129.6040692.100.99数据可信
供试品溶液-2024010911批-pH6.8(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%
5min1334607-33460761.85657.597.0161.8657.597.01
2297278-29727854.95554.95
3325127-32512760.10360.10
4330120-33012061.02661.03
5279396-27939651.64951.65
6302590-30259055.93755.94
10min1415783-41578376.86273.074.5477.0073.204.54
2382073-38207370.63070.75
3405863-40586375.02875.16
4410127-41012775.81675.95
5370506-37050668.49268.61
6387386-38738671.61271.74
15min1447787-44778782.77880.562.4083.0980.852.41
2427893-42789379.10079.38
3443256-44325681.94082.24
4443533-44353381.99282.30
5422020-42202078.01578.28
6430100-43010079.50879.79
20min1464812-46481285.92584.641.1886.4285.111.20
2451701-45170183.50283.96
3462205-46220585.44385.93
4460700-46070085.16585.65
5454229-45422983.96984.41
6453434-45343483.82284.28
30min1482682-48268289.22988.750.6489.9189.410.64
2475759-47575987.94988.59
3480173-48017388.76589.44
4478670-47867088.48789.16
5484360-48436089.53990.17
6478938-47893888.53789.18
45min1494269-49426991.37191.200.8292.2592.050.81
2488845-48884590.36891.20
3492165-49216590.98291.85
4491120-49112090.78991.66
5500674-50067492.55593.38
6492925-49292591.12291.97
60min1504450-50445093.25392.250.6394.3493.310.63
2498174-49817492.09393.13
3495718-49571891.63992.71
4496423-49642391.76992.84
5499427-49942792.32493.36
6500091-50009192.44793.49
极限1504678-50467893.29592.890.9494.5994.150.92
2496412-49641291.76793.01
3500069-50006992.44393.72
4499746-49974692.38393.66
5509690-50969094.22195.46
6504324-50432493.22994.48
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