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%
112.184941084957844949414956054943074949490.16
212.245004805003725004260.02
单位质量响应值RSD%判断
40636.2140884.480.44数据可信
供试品溶液-2024010911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%
5min1283901-28390152.03050.747.4252.0350.747.42
2241396-24139644.24044.24
3282278-28227851.73351.73
4303427-30342755.60855.61
5280622-28062251.42951.43
6269687-26968749.42549.43
10min1372073-37207368.18966.476.9168.3066.586.90
2328700-32870060.24060.34
3369910-36991067.79367.91
4387054-38705470.93571.06
5334479-33447961.29961.41
6383812-38381270.34070.45
15min1416074-41607476.25374.364.1276.5274.624.11
2377855-37785569.24969.48
3403946-40394674.03074.30
4414697-41469776.00176.28
5424532-42453277.80378.05
6397310-39731072.81473.08
20min1443340-44334081.25079.533.1681.6979.963.18
2409693-40969375.08475.47
3440897-44089780.80281.23
4447964-44796482.09782.55
5430046-43004678.81479.24
6431943-43194379.16179.59
30min1473613-47361386.79885.221.8987.4285.831.91
2450251-45025182.51783.07
3468261-46826185.81786.43
4473169-47316986.71787.35
5463203-46320384.89085.49
6461585-46158584.59485.20
45min1488554-48855489.53688.950.6090.3589.740.63
2480444-48044488.05088.79
3486227-48622789.11089.91
4487504-48750489.34490.17
5485548-48554888.98589.77
6483756-48375688.65789.45
60min1499042-49904291.45890.730.6692.4791.720.68
2492100-49210090.18691.12
3496677-49667791.02592.02
4496678-49667891.02592.05
5495570-49557090.82291.81
6490292-49029289.85590.84
极限1502437-50243792.08191.600.5793.2992.790.59
2496172-49617290.93292.06
3501828-50182891.96993.17
4500126-50012691.65792.88
5496478-49647890.98992.18
6501873-50187391.97793.17
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%
112.184978504984524998174990324997614989820.17
212.245011065008705009880.04
单位质量响应值RSD%判断
40967.3240930.390.07数据可信
供试品溶液-2024010911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%
5min1297696-29769654.30750.344.8254.3150.344.82
2262007-26200747.79647.80
3268679-26867949.01349.01
4265549-26554948.44248.44
5279294-27929450.95050.95
6282482-28248251.53151.53
10min1379646-37964669.25666.612.9969.3866.723.00
2353101-35310164.41464.52
3375996-37599668.59068.70
4354367-35436764.64564.75
5365123-36512366.60766.72
6362549-36254966.13766.25
15min1425318-42531877.58874.742.2277.8675.002.22
2402335-40233573.39573.64
3410578-41057874.89975.16
4402842-40284273.48873.74
5402941-40294173.50673.77
6414087-41408775.53975.80
20min1447623-44762381.65779.781.3782.1080.211.38
2430308-43030878.49878.91
3438417-43841779.97780.40
4433357-43335779.05479.47
5438982-43898280.08080.50
6435397-43539779.42679.86
30min1473656-47365686.40685.250.7087.0385.850.70
2465410-46541084.90185.49
3464857-46485784.80085.41
4467226-46722685.23385.82
5465886-46588684.98885.59
6466769-46676985.14985.76
45min1488518-48851889.11788.540.8789.9489.330.87
2485553-48555388.57689.35
3477004-47700487.01687.81
4487525-48752588.93689.72
5486338-48633888.71989.51
6487042-48704288.84889.64
60min1493454-49345490.01790.080.8291.0491.070.81
2497159-49715990.69391.67
3495678-49567890.42391.41
4486197-48619788.69389.67
5493776-49377690.07691.06
6496528-49652890.57891.57
极限1500398-50039891.28491.930.7992.5093.120.78
2502538-50253891.67492.85
3510815-51081593.18494.37
4502079-50207991.59192.77
5501202-50120291.43192.62
6506474-50647492.39293.59
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%
112.184958134961884960134951844940384954470.18
212.244998954986184992560.19
单位质量响应值RSD%判断
40677.0940788.890.20数据可信
供试品溶液-JPS5451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%
5min1353206-35320664.77462.902.6064.7762.902.60
2346249-34624963.49963.50
3329386-32938660.40660.41
4340543-34054362.45262.45
5350877-35087764.34764.35
6337743-33774361.93961.94
10min1406232-40623274.49973.061.5574.6473.201.55
2395606-39560672.55072.69
3390826-39082671.67371.81
4397459-39745972.89073.03
5405404-40540474.34774.49
6394884-39488472.41872.56
15min1431017-43101779.04477.741.0879.3578.041.08
2419171-41917176.87277.17
3420222-42022277.06477.36
4423491-42349177.66477.96
5427554-42755478.40978.72
6422099-42209977.40977.71
20min1444394-44439481.49780.540.9081.9881.020.90
2435510-43551079.86880.34
3437500-43750080.23380.70
4438077-43807780.33980.81
5443740-44374081.37781.86
6435861-43586179.93280.40
30min1463120-46312084.93184.030.8485.6084.680.84
2452715-45271583.02383.67
3456956-45695683.80184.44
4455467-45546783.52884.18
5460876-46087684.52085.18
6459949-45994984.35085.00
45min1476132-47613287.31886.460.7888.1787.300.78
2466624-46662485.57486.41
3471299-47129986.43187.26
4470114-47011486.21487.05
5475344-47534487.17388.02
6469260-46926086.05786.89
60min1483867-48386788.73687.980.7089.7989.010.71
2476571-47657187.39888.42
3479343-47934387.90788.93
4478671-47867187.78388.81
5483710-48371088.70789.75
6476271-47627187.34388.37
极限1491534-49153490.14289.150.9591.3990.380.95
2478822-47882287.81189.03
3486161-48616189.15790.37
4485177-48517788.97790.20
5490488-49048889.95091.19
6484626-48462688.87590.10
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%
112.184935294929974933504935064935484933860.05
212.244998665002355000500.06
单位质量响应值RSD%判断
40507.8840853.760.61数据可信
供试品溶液-JPS5451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%
5min1350336-35033664.33163.582.5064.3363.582.50
2336739-33673961.83561.83
3338735-33873562.20162.20
4350440-35044064.35164.35
5359398-35939865.99666.00
6341882-34188262.77962.78
10min1404015-40401574.18874.111.9374.3374.251.93
2396676-39667672.84172.98
3403359-40335974.06874.21
4413315-41331575.89676.04
5410920-41092075.45675.60
6393267-39326772.21572.35
15min1428602-42860278.70378.791.7279.0179.101.72
2426125-42612578.24878.55
3435569-43556979.98380.29
4432831-43283179.48079.79
5435227-43522779.92080.23
6416140-41614076.41576.71
20min1444108-44410881.55181.731.8482.0382.211.83
2443603-44360381.45881.93
3454602-45460283.47883.96
4448060-44806082.27682.76
5449601-44960182.55983.05
6430595-43059579.06979.54
30min1460877-46087784.63085.242.0485.2985.902.03
2463815-46381585.16985.82
3477364-47736487.65788.32
4466690-46669085.69786.37
5467817-46781785.90486.58
6448648-44864882.38483.03
45min1475764-47576487.36488.052.1588.2288.902.14
2478689-47868987.90188.74
3493051-49305190.53891.40
4481962-48196288.50289.36
5485206-48520689.09789.96
6462439-46243984.91785.75
60min1487089-48708989.44389.811.9890.4990.851.98
2488353-48835389.67590.71
3502217-50221792.22193.28
4491637-49163790.27891.34
5492484-49248490.43491.50
6472619-47261986.78687.80
极限1492743-49274390.48191.001.8491.7392.241.84
2494241-49424190.75691.99
3508205-50820593.32194.59
4498192-49819291.48292.74
5499298-49929891.68592.95
6480641-48064188.25989.47
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