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对照品来源工作对照品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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.539874698677979009797497901982400.45
211.639696397057970100.07
单位质量响应值RSD%判断
8520.388341.361.51数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min181035-8103582.31289.087.8182.3189.087.81
297466-9746699.00299.00
380360-8036081.62681.63
484843-8484386.18086.18
589284-8928490.69190.69
693184-9318494.65294.65
10min1101773-101773103.377101.072.60103.83101.562.60
2100765-100765102.353102.90
395599-9559997.10597.56
496987-9698798.51598.99
5101570-101570103.171103.67
6100328-100328101.909102.43
15min1104574-104574106.222101.983.01107.25103.043.00
2101098-101098102.691103.81
396559-9655998.08199.07
497285-9728598.81899.84
5100734-100734102.321103.40
6102135-102135103.744104.84
20min1104550-104550106.198101.572.77107.82103.192.76
2100054-100054101.631103.32
397282-9728298.815100.35
496956-9695698.484100.06
5100145-100145101.723103.37
6100949-100949102.540104.21
30min1101171-101171102.76599.832.21104.98102.022.20
298630-98630100.184102.44
396464-9646497.984100.07
495691-9569197.19999.32
5100330-100330101.911104.12
697425-9742598.960101.20
45min1102372-102372103.98599.712.62106.77102.452.60
298364-9836499.914102.72
396218-9621897.734100.37
495172-9517296.67299.33
597349-9734998.883101.66
699502-99502101.070103.86
60min1102838-102838104.45999.243.51107.82102.543.47
297306-9730698.839102.20
394579-9457996.06999.24
493391-9339194.86398.06
598853-98853100.411103.74
699233-99233100.797104.15
极限1100364-100364101.94698.602.97105.89102.452.94
295449-9544996.953100.87
394008-9400895.48999.20
494142-9414295.62699.35
599768-99768101.340105.22
698687-98687100.242104.15
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ZT-705-231101-1-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100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%
111.108909088980883428842588448886570.40
211.078683387052869420.18
单位质量响应值RSD%判断
7987.127853.841.19数据可信
供试品溶液-2023122321批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0004.1849.880.004.1849.88
25082-50825.7755.78
34393-43934.9924.99
44185-41854.7564.76
54142-41424.7074.71
64276-42764.8594.86
10min16600-66007.5007.763.077.507.783.15
27162-71628.1398.17
36758-67587.6807.71
46891-68917.8317.86
56913-69137.8567.88
66629-66297.5337.56
15min16838-68387.7717.862.117.817.922.18
26963-69637.9137.99
36674-66747.5847.65
47054-70548.0168.09
56890-68907.8307.90
67055-70558.0178.09
20min16973-69737.9247.871.238.017.981.16
26896-68967.8367.96
36853-68537.7887.90
46974-69747.9258.04
56806-68067.7347.85
67031-70317.9908.10
30min16676-66767.5867.721.877.727.881.88
26793-67937.7197.88
36954-69547.9028.06
46665-66657.5747.73
56940-69407.8868.04
66742-67427.6617.82
45min16813-68137.7427.721.497.917.921.38
26617-66177.5197.73
36781-67817.7067.91
46919-69197.8638.06
56797-67977.7247.92
66849-68497.7837.98
60min16873-68737.8107.692.018.027.921.84
26572-65727.4687.72
36763-67637.6857.93
46648-66487.5557.80
56788-67887.7147.96
66935-69357.8818.12
极限16521-65217.4107.632.107.677.912.13
26837-68377.7698.06
36656-66567.5647.85
46672-66727.5827.87
56667-66677.5767.86
66912-69127.8558.14
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对照品来源工作对照品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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.539722597085973829731797427972870.14
211.639728697097971920.14
单位质量响应值RSD%判断
8437.738357.010.68数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193777-9377795.62697.515.8495.6397.515.84
299246-99246101.203101.20
398497-98497100.439100.44
499574-99574101.538101.54
597576-9757699.50099.50
685064-8506486.74186.74
10min197877-9787799.807103.653.25100.34104.193.26
2103344-103344105.382105.94
3101229-101229103.225103.78
4106287-106287108.383108.95
5103144-103144105.178105.73
697974-9797499.906100.39
15min197674-9767499.600102.942.66100.69104.062.65
2102228-102228104.244105.39
3103569-103569105.611106.74
498834-98834100.783101.95
5104055-104055106.107107.24
699342-99342101.301102.34
20min197252-9725299.170102.762.76100.81104.452.76
2103455-103455105.495107.22
3102793-102793104.820106.54
499793-99793101.761103.49
5103306-103306105.343107.07
698027-9802799.960101.56
30min197802-9780299.731101.592.30101.92103.852.31
2101313-101313103.311105.62
3102306-102306104.323106.62
498027-9802799.960102.25
5101393-101393103.392105.70
696940-9694098.852101.01
45min197058-9705898.972101.512.35101.72104.342.34
2101582-101582103.585106.47
3102378-102378104.397107.28
497229-9722999.146101.99
5100831-100831102.819105.71
698199-98199100.135102.84
60min195996-9599697.88999.422.56101.18102.812.54
299609-99609101.573105.04
398841-98841100.790104.25
494049-9404995.90499.30
5100428-100428102.408105.87
696084-9608497.979101.24
极限193805-9380595.65599.292.2199.49103.232.21
298938-98938100.889104.92
397617-9761799.542103.56
498766-98766100.714104.64
599246-99246101.203105.23
695838-9583897.728101.53
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ZT-705-231101-1-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100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%
111.108809387634883178817587970880380.30
211.078827888225882520.05
单位质量响应值RSD%判断
7931.357972.180.37数据可信
供试品溶液-2023122321批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14890-48905.5355.5112.235.535.5112.20
24641-46415.2535.25
35155-51555.8355.83
45887-58876.6636.66
54414-44144.9965.00
64239-42394.7984.80
10min16679-66797.5607.918.427.597.948.41
26843-68437.7457.77
38162-81629.2389.27
46789-67897.6847.72
56886-68867.7947.82
66560-65607.4257.45
15min16893-68937.8027.882.047.877.962.04
26809-68097.7077.78
37121-71218.0608.14
47054-70547.9848.06
57097-70978.0338.10
66821-68217.7207.79
20min16766-67667.6587.852.487.777.962.48
26962-69627.8807.99
37043-70437.9718.10
46969-69697.8888.01
57164-71648.1088.22
66706-67067.5907.70
30min17217-72178.1687.881.968.338.051.92
26974-69747.8938.05
36942-69427.8578.03
46823-68237.7227.89
56970-69707.8898.05
66873-68737.7797.93
45min16879-68797.7867.702.347.997.902.23
26881-68817.7887.99
36818-68187.7177.93
46630-66307.5047.71
56595-65957.4647.67
67004-70047.9278.12
60min16569-65697.4357.402.017.687.651.88
26575-65757.4427.69
36489-64897.3447.60
46320-63207.1537.41
56721-67217.6077.85
66555-65557.4197.66
极限16561-65617.4267.692.467.717.982.39
26719-67197.6057.89
36662-66627.5407.84
46965-69657.8838.18
56943-69437.8588.15
66896-68967.8058.09
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