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%
112.384761874758424757564762564760514760180.05
212.464752954750494751720.04
单位质量响应值RSD%判断
38450.5738135.790.59数据可信
加速3月-供试品溶液-2024010711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%
5min1268688-26868852.41560.526.9552.4160.526.95
2330854-33085464.54264.54
3319014-31901462.23262.23
4318288-31828862.09162.09
5315219-31521961.49261.49
6309430-30943060.36360.36
10min1357492-35749269.73974.853.6369.8674.983.63
2396549-39654977.35877.50
3385824-38582475.26575.40
4390809-39080976.23876.38
5390838-39083876.24476.38
6380585-38058574.24374.38
15min1398470-39847077.73280.772.0078.0081.072.02
2422104-42210482.34382.66
3413782-41378280.71981.02
4418439-41843981.62881.94
5417978-41797881.53881.84
6413608-41360880.68580.98
20min1420235-42023581.97884.061.3282.4284.541.34
2436293-43629385.11185.61
3429419-42941983.77084.25
4433290-43329084.52585.01
5433037-43303784.47684.96
6433315-43331584.53085.01
30min1448830-44883087.55687.950.7088.1888.620.70
2453475-45347588.46389.15
3446100-44610087.02487.70
4450221-45022187.82888.50
5451877-45187788.15188.83
6454587-45458788.68089.35
45min1459473-45947389.63390.320.8190.4591.180.82
2465789-46578990.86591.75
3458444-45844489.43290.30
4461991-46199190.12491.00
5464085-46408590.53291.40
6468207-46820791.33792.20
60min1464617-46461790.63691.580.9791.6692.640.97
2473243-47324392.31993.40
3464219-46421990.55991.62
4468981-46898191.48792.56
5470166-47016691.71992.79
6475516-47551692.76293.83
极限1472978-47297892.26792.800.8193.4994.060.82
2479156-47915693.47294.76
3470782-47078291.83993.10
4473736-47373692.41593.69
5476859-47685993.02494.30
6480730-48073093.77995.05
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%
112.384790284790174791994789824790824790620.02
212.464807084803204805140.06
单位质量响应值RSD%判断
38696.4538564.530.25数据可信
加速3月-供试品溶液-2024010811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%
5min1274165-27416553.01658.978.7053.0258.978.69
2314795-31479560.87260.87
3281000-28100054.33754.34
4331619-33161964.12664.13
5336607-33660765.09065.09
6291515-29151556.37156.37
10min1363737-36373770.33674.944.9670.4575.064.96
2393426-39342676.07776.21
3370887-37088771.71971.84
4405530-40553078.41878.56
5411633-41163379.59879.74
6379919-37991973.46573.59
15min1406847-40684778.67282.333.1878.9582.623.19
2428402-42840282.84183.14
3416074-41607480.45780.74
4437763-43776384.65184.97
5443037-44303785.67185.99
6422373-42237381.67581.96
20min1429582-42958283.06986.222.4183.5286.702.42
2447879-44787986.60787.10
3439714-43971485.02885.49
4453868-45386887.76588.27
5460029-46002988.95689.47
6444194-44419485.89486.36
30min1457919-45791988.54890.301.3789.1890.971.39
2466642-46664290.23590.92
3462751-46275189.48390.13
4471642-47164291.20291.90
5475995-47599592.04492.75
6466947-46694790.29490.95
45min1469989-46998990.88292.661.3291.7193.531.34
2478124-47812492.45593.34
3475546-47554691.95792.80
4483180-48318093.43394.34
5488234-48823494.41095.32
6479942-47994292.80793.67
60min1477426-47742692.32093.941.3493.3595.021.36
2483930-48393093.57894.66
3481280-48128093.06694.12
4489268-48926894.61095.72
5495928-49592895.89897.02
6487028-48702894.17795.24
极限1480212-48021292.85994.651.3694.1095.941.37
2487409-48740994.25195.55
3484956-48495693.77795.03
4493160-49316095.36396.68
5498799-49879996.45397.79
6492322-49232295.20196.48
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%
112.384783134785974785904785054781294784270.05
212.464797284794294795780.05
单位质量响应值RSD%判断
38645.1538489.410.29数据可信
加速3月-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%
5min1330149-33014963.94662.704.7463.9562.704.74
2328797-32879763.68463.68
3294120-29412056.96856.97
4336481-33648165.17265.17
5321088-32108862.19162.19
6331732-33173264.25364.25
10min1407476-40747678.92378.272.1979.0778.412.20
2406983-40698378.82878.97
3388246-38824675.19975.33
4410425-41042579.49579.64
5399605-39960577.39977.54
6411861-41186179.77379.92
15min1439400-43940085.10784.851.2485.4285.161.24
2439566-43956685.13985.46
3429894-42989483.26583.56
4441127-44112785.44185.76
5433586-43358683.98184.29
6444765-44476586.14686.47
20min1456461-45646188.41188.350.6988.9288.850.70
2457912-45791288.69289.20
3451705-45170587.49087.97
4456249-45624988.37088.88
5453847-45384787.90588.40
6460607-46060789.21489.73
30min1475595-47559592.11791.840.4392.8292.540.44
2476357-47635792.26592.97
3471579-47157991.33992.01
4473017-47301791.61892.33
5472521-47252191.52292.21
6475870-47587092.17092.88
45min1488184-48818494.55694.200.4795.4695.100.47
2489047-48904794.72395.63
3485296-48529693.99694.87
4483572-48357293.66294.57
5484271-48427193.79894.69
6487585-48758594.44095.35
60min1493830-49383095.64995.320.5896.7796.430.58
2495837-49583796.03897.16
3490132-49013294.93396.02
4489301-48930194.77295.89
5489470-48947094.80595.91
6494200-49420095.72196.85
极限1456994-45699488.51491.071.7289.8492.401.69
2472921-47292191.59992.93
3472594-47259491.53692.83
4466877-46687790.42991.76
5481503-48150393.26194.58
6470323-47032391.09692.43
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