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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159340493446933949315092967932720.23
211.239296093150930550.15
单位质量响应值RSD%判断
8365.208286.290.68数据可信
供试品溶液-JT1707批-瑞舒伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min157005-5700558.50754.665.8558.5154.665.86
256206-5620657.68757.69
348671-4867149.95449.95
452235-5223553.61253.61
551457-5145752.81352.81
653938-5393855.35955.36
10min178672-7867280.74579.642.7081.0779.942.71
279453-7945381.54781.87
375185-7518577.16677.44
479109-7910981.19481.49
574685-7468576.65376.95
678466-7846680.53480.84
15min189026-8902691.37289.671.5892.1590.421.58
287452-8745289.75790.53
388338-8833890.66691.37
487202-8720289.50090.25
584974-8497487.21387.93
687229-8722989.52890.28
20min192806-9280695.25294.011.3796.5395.251.38
292428-9242894.86496.14
391073-9107393.47394.68
492090-9209094.51795.76
589348-8934891.70392.91
691810-9181094.22995.48
30min195705-9570598.22797.291.70100.0499.061.68
293331-9333195.79197.59
395834-9583498.360100.09
496994-9699499.550101.32
592989-9298995.44097.15
693926-9392696.40198.18
45min196852-9685299.40498.471.19101.76100.781.20
295644-9564498.164100.50
396130-9613098.663100.94
497143-9714399.703102.03
593918-9391896.39398.64
695973-9597398.502100.81
60min197322-9732299.88798.281.92102.80101.141.88
293549-9354996.01498.89
397244-9724499.807102.63
497662-97662100.236103.11
594452-9445296.94199.72
694338-9433896.82499.68
极限196022-9602298.55297.981.38102.02101.381.37
295243-9524397.753101.16
396715-9671599.264102.64
496755-9675599.305102.74
593388-9338895.84999.17
694633-9463397.127100.52
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.389019989996897758949090029898980.31
211.449013989913900260.18
单位质量响应值RSD%判断
7899.657869.410.28数据可信
供试品溶液-JT1707批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14798-47985.4634.8513.685.464.8513.66
24498-44985.1225.12
33789-37894.3144.31
44234-42344.8214.82
54869-48695.5445.54
63388-33883.8583.86
10min17936-79369.0368.845.279.078.875.30
27873-78738.9648.99
37355-73558.3758.40
48240-82409.3829.41
58001-80019.1109.14
67178-71788.1738.19
15min18219-82199.3589.232.349.449.312.36
28242-82429.3859.46
38244-82449.3879.46
47936-79369.0369.12
58200-82009.3379.42
67804-78048.8868.95
20min18104-81049.2279.252.469.369.382.49
28298-82989.4489.58
38068-80689.1869.31
48209-82099.3479.48
58314-83149.4679.60
67775-77758.8538.97
30min18026-80269.1399.041.669.329.221.68
27982-79829.0899.27
37747-77478.8218.99
48124-81249.2509.43
57875-78758.9679.15
67893-78938.9879.15
45min18025-80259.1378.943.509.379.173.43
28318-83189.4719.70
37702-77028.7708.99
47831-78318.9179.15
57600-76008.6548.89
67644-76448.7048.92
60min18087-80879.2088.951.819.499.221.82
27918-79189.0169.30
37817-78178.9019.17
47834-78348.9209.20
57837-78378.9239.21
67653-76538.7148.98
极限17827-78278.9128.772.109.259.102.14
27930-79309.0299.37
37658-76588.7209.04
47706-77068.7749.11
57636-76368.6959.03
67465-74658.5008.81
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159323993029930719311293013930930.10
211.239290293080929910.14
单位质量响应值RSD%判断
8349.158280.590.59数据可信
供试品溶液-JT1707批-瑞舒伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154068-5406855.56553.547.2055.5753.547.20
251877-5187753.31353.31
346648-4664847.94047.94
450631-5063152.03352.03
551430-5143052.85452.85
657938-5793859.54259.54
10min176418-7641878.53478.043.3378.8478.343.35
275088-7508877.16777.46
373452-7345275.48675.75
474298-7429876.35576.64
575749-7574977.84678.14
680639-8063982.87283.20
15min182778-8277885.07087.043.4185.8287.773.41
283915-8391586.23986.96
383840-8384086.16286.85
482755-8275585.04685.76
584446-8444686.78487.51
690414-9041492.91893.71
20min188923-8892391.38591.992.0392.6093.212.05
288020-8802090.45791.66
388932-8893291.39592.56
488030-8803090.46891.65
590425-9042592.92994.14
692756-9275695.32496.63
30min191740-9174094.28095.013.8396.0196.743.81
287200-8720089.61591.32
392113-9211394.66496.34
491706-9170694.24595.93
593863-9386396.46298.19
698090-98090100.806102.64
45min190593-9059393.10296.542.8595.3598.792.85
292936-9293695.50997.71
392836-9283695.40797.60
493902-9390296.50298.71
594745-9474597.36899.63
698605-98605101.335103.73
60min190948-9094893.46695.672.3696.2398.462.37
291530-9153094.06496.80
391778-9177894.31997.05
492936-9293695.50998.26
594677-9467797.299100.10
696663-9666399.340102.30
极限187862-8786290.29594.903.6593.5898.233.61
290541-9054193.04896.31
392293-9229394.84998.10
491998-9199894.54597.82
593380-9338095.96699.31
698012-98012100.726104.24
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.389010389758898658965889967898700.20
211.448959289956897740.29
单位质量响应值RSD%判断
7897.197847.380.45数据可信
供试品溶液-JT1707批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13559-35594.0594.1217.004.064.1217.02
23439-34393.9223.92
33374-33743.8483.85
44804-48045.4795.48
53495-34953.9863.99
63011-30113.4343.43
10min16854-68547.8168.266.867.848.286.89
26814-68147.7717.79
37052-70528.0428.06
48083-80839.2189.25
57585-75858.6508.67
67054-70548.0448.06
15min17753-77538.8429.072.048.919.142.02
27868-78688.9739.04
37875-78758.9819.05
48113-81139.2529.33
57942-79429.0579.13
68180-81809.3299.39
20min17866-78668.9709.062.139.099.182.15
27900-79009.0099.12
38031-80319.1599.27
48240-82409.3979.53
57803-78038.8999.02
67804-78048.9009.02
30min17691-76918.7718.933.198.949.103.13
27610-76108.6788.84
37767-77678.8589.02
47819-78198.9179.10
57793-77938.8879.06
68317-83179.4859.65
45min17583-75838.6488.882.548.869.102.53
27738-77388.8249.04
37858-78588.9619.18
47953-79539.0709.30
58049-80499.1799.40
67565-75658.6278.84
60min17908-79089.0188.781.699.289.041.59
27617-76178.6868.95
37619-76198.6898.95
47545-75458.6048.89
57736-77368.8229.09
67745-77458.8329.10
极限17533-75338.5918.862.048.909.182.01
27658-76588.7339.04
37947-79479.0639.38
47746-77468.8349.17
57847-78478.9499.27
67905-79059.0159.33
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