依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.154607364619634621944628294618004619040.17
211.234596544593104594820.06
单位质量响应值RSD%判断
41426.3740915.580.88数据可信
供试品溶液-JT1707批-依折麦布-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1297548-29754861.75868.3313.2961.7668.3313.29
2275996-27599657.28557.28
3381612-38161279.20679.21
4323258-32325867.09467.09
5381661-38166179.21679.22
6315126-31512665.40665.41
10min1464305-46430596.36993.533.6296.4793.653.62
2438296-43829690.97191.07
3453303-45330394.08694.22
4466839-46683996.89597.01
5456569-45656994.76494.90
6424508-42450888.10988.22
15min1490059-490059101.71599.012.44101.9899.282.44
2470121-47012197.57797.82
3471807-47180797.92698.22
4492810-492810102.286102.56
5473498-47349898.27798.57
6463977-46397796.30196.56
20min1493958-493958102.524100.082.16102.96100.522.15
2476170-47617098.83299.24
3472916-47291698.15798.61
4496868-496868103.128103.57
5475855-47585598.76799.22
6477421-47742199.09299.51
30min1495130-495130102.767100.212.13103.37100.812.12
2477302-47730299.06799.64
3473962-47396298.37498.99
4496516-496516103.055103.67
5475025-47502598.59499.21
6478803-47880399.37999.96
45min1494125-494125102.55999.952.05103.33100.722.05
2476376-47637698.87599.61
3472792-47279298.13198.91
4494001-494001102.533103.32
5473887-47388798.35899.14
6478113-47811399.23599.98
60min1492508-492508102.22399.682.18103.17100.612.17
2474937-47493798.57699.48
3471206-47120697.80298.74
4494392-494392102.614103.57
5471486-47148697.86098.81
6476950-47695098.99499.91
极限1491178-491178101.94799.492.18103.06100.602.17
2473460-47346098.27099.34
3470465-47046597.64898.75
4493824-493824102.496103.63
5470925-47092597.74398.85
6476317-47631798.86399.94
依折麦布瑞舒伐他汀钙片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.384499924485444493304495344488714492540.13
211.444475974481274478620.09
单位质量响应值RSD%判断
39477.5039148.780.60数据可信
供试品溶液-JT1707批-瑞舒伐他汀钙-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1123217-12321728.13825.4918.9928.1425.4919.00
2115912-11591226.47026.47
3105627-10562724.12124.12
4139942-13994231.95831.96
5108641-10864124.81024.81
676336-7633617.43217.43
10min1333615-33361576.18572.3216.4976.2372.3616.49
2327756-32775674.84774.89
3308029-30802970.34270.38
4383151-38315187.49787.55
5323955-32395573.97974.02
6223568-22356851.05551.08
15min1425746-42574697.22594.059.1597.4094.229.16
2423985-42398596.82296.99
3425334-42533497.13097.29
4431324-43132498.49898.70
5429556-42955698.09598.26
6335163-33516376.53976.65
20min1434332-43433299.18597.123.2499.5297.443.27
2424263-42426396.88697.22
3431428-43142898.52298.84
4432418-43241898.74899.11
5431293-43129398.49198.82
6398104-39810490.91291.15
30min1433932-43393299.09497.851.0599.6098.331.08
2423803-42380396.78197.27
3430696-43069698.35598.84
4429378-42937898.05498.58
5430807-43080798.38098.87
6422327-42232796.44496.84
45min1432495-43249598.76697.650.9499.4398.290.97
2422469-42246996.47697.13
3428822-42882297.92798.57
4429289-42928998.03498.72
5429554-42955498.09498.75
6422901-42290196.57597.13
60min1430945-43094598.41297.490.7999.2498.290.81
2421715-42171596.30497.12
3427907-42790797.71898.53
4428510-42851097.85698.71
5428092-42809297.76098.58
6424155-42415596.86197.58
极限1429674-42967498.12297.380.7099.1298.350.72
2421953-42195396.35897.33
3426732-42673297.45098.42
4428198-42819897.78498.80
5428219-42821997.78998.77
6423841-42384196.78997.67
依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.154594674590344589214591274601994593500.12
211.234598154596084597120.04
单位质量响应值RSD%判断
41197.3140936.060.45数据可信
供试品溶液-JT1707批-依折麦布-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1383537-38353779.80566.8023.8579.8166.8023.85
2177709-17770936.97736.98
3317220-31722066.00666.01
4353284-35328473.51073.51
5382004-38200479.48679.49
6312393-31239365.00265.00
10min1456310-45631094.94894.463.8395.0894.583.85
2421723-42172387.75187.81
3448771-44877193.37993.49
4466101-46610196.98597.11
5468785-46878597.54497.68
6462171-46217196.16796.28
15min1472102-47210298.23499.762.6198.52100.032.63
2462192-46219296.17296.38
3472541-47254198.32598.59
4495500-495500103.102103.39
5488797-488797101.708102.00
6485595-485595101.041101.31
20min1473019-47301998.425100.782.1498.88101.222.14
2475027-47502798.84299.21
3478293-47829399.52299.95
4498437-498437103.713104.17
5491829-491829102.338102.80
6489440-489440101.841102.28
30min1473520-47352098.529101.001.9699.15101.601.96
2479359-47935999.744100.28
3479436-47943699.760100.36
4498822-498822103.794104.42
5491663-491663102.304102.94
6489491-489491101.852102.46
45min1471179-47117998.042100.692.0598.82101.462.05
2477318-47731899.319100.02
3478678-47867899.602100.36
4497741-497741103.569104.37
5491023-491023102.171102.98
6487552-487552101.449102.23
60min1470831-47083197.969100.361.9698.92101.301.97
2475613-47561398.96499.83
3476472-47647299.143100.07
4495341-495341103.069104.04
5489406-489406101.834102.81
6486155-486155101.158102.10
极限1470409-47040997.881100.121.9598.99101.221.96
2473764-47376498.58099.61
3475215-47521598.88199.97
4494184-494184102.828103.97
5486380-486380101.205102.35
6487039-487039101.342102.46
依折麦布瑞舒伐他汀钙片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.384473784488484485684476154487954482410.16
211.444478054480544479300.04
单位质量响应值RSD%判断
39388.4939154.720.43数据可信
供试品溶液-JT1707批-瑞舒伐他汀钙-pH7.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1136564-13656431.21924.5322.1031.2224.5322.09
276293-7629317.44117.44
387427-8742719.98619.99
4100285-10028522.92522.93
5113256-11325625.89125.89
6129917-12991729.69929.70
10min1356716-35671681.54672.3511.2681.6072.3911.27
2262347-26234759.97360.00
3297700-29770068.05568.09
4300701-30070168.74168.78
5337758-33775877.21277.26
6343637-34363778.55678.61
15min1427513-42751397.73095.054.2297.9295.214.23
2383539-38353987.67887.81
3419693-41969395.94396.09
4409295-40929593.56693.72
5431327-43132798.60298.77
6423261-42326196.75896.94
20min1426553-42655397.51198.300.5897.8698.620.57
2428897-42889798.04798.32
3433610-43361099.12499.43
4429317-42931798.14398.45
5431875-43187598.72899.06
6429673-42967398.22498.57
30min1425828-42582897.34598.140.6597.8698.620.63
2428421-42842197.93898.38
3431846-43184698.72199.19
4432924-43292498.96799.44
5429824-42982498.25998.76
6426950-42695097.60298.11
45min1424056-42405696.94097.860.6797.6298.510.65
2426983-42698397.60998.21
3430980-43098098.52399.16
4431713-43171398.69199.33
5427944-42794497.82998.49
6426898-42689897.59098.26
60min1423523-42352396.81897.590.5897.6698.400.57
2426013-42601397.38898.15
3429414-42941498.16598.97
4430002-43000298.29999.10
5427058-42705897.62698.45
6425353-42535397.23798.07
极限1422733-42273396.63897.370.5797.6498.340.56
2424528-42452897.04897.97
3427961-42796197.83398.80
4429485-42948598.18199.15
5425689-42568997.31398.30
6425273-42527397.21898.21
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