氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991443322144276614399711440107144101214414360.11
211.141443034144595714444960.15
单位质量响应值RSD%判断
131158.87129667.500.81数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min19922199982996026.7726.489.476.776.489.48
21052051053581052827.1587.16
39087790805908416.1766.18
49014990320902346.1356.13
51034231035301034767.0357.04
68211681956820365.5785.58
120min139004439004339004426.51925.939.4526.5325.949.45
240436940537140487027.52727.54
337049537118037083825.21325.22
436267236250136258624.65224.66
543233243160043196629.36929.38
632841832789332815622.31122.32
240min183590683535283562956.81456.137.5556.8656.187.55
286987088845887916459.77459.83
385021484982585002057.79357.84
482540082508482524256.10856.15
585926585885285905858.40758.46
670418970448070433447.88747.93
480min1149739614959121496654101.757100.474.57101.89100.604.57
2150927815085881508933102.592102.73
3150251715020401502278102.139102.27
4151012215093701509746102.647102.78
5150894515079041508424102.557102.70
613403571340435134039691.13391.25
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991446932144620414454821445639144620414460920.04
211.141443397144326014433280.01
单位质量响应值RSD%判断
131582.53129562.661.10数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min18832188761885416.0136.353.526.016.353.55
29470494852947786.4366.44
39225992624924426.2786.28
49332393521934226.3446.34
59867698615986466.6996.70
69302292849929366.3116.31
120min133884733866033875423.00425.437.2223.0125.447.23
235193635248935221223.91823.93
338263238263338263225.98425.99
437260037277337268625.30925.32
541554141575441564828.22628.24
638518038528038523026.16026.17
240min172404472458272431349.18754.967.3249.2355.017.32
274338374384574361450.49850.54
383707483599383653456.80856.86
484882084825484853757.62357.67
586096685980286038458.42758.48
684244784267684256257.21757.27
480min1148608814876531486870100.971101.650.57101.09101.780.57
2148630414869451486624100.954101.08
3150422515052321504728102.184102.32
4149771814984951498106101.734101.87
5150154214975611499552101.832101.97
6150377715076091505693102.249102.38
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991441367144132814419111441241144130314414300.02
211.141451658145075714512080.05
单位质量响应值RSD%判断
131158.33130270.020.49数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min11145471146471145977.7736.698.887.776.708.87
29082590285905556.1426.14
39616396266962146.5266.53
49743497700975676.6186.62
51015761015571015666.8896.89
69180091615917086.2216.22
120min139086839119839103326.52426.401.8526.5426.401.85
237472637494437483525.42625.43
339313039444539378826.71126.72
439026739028939027826.47326.48
539393539368539381026.71326.72
639116239116739116426.53326.54
240min189109489152589131060.45960.282.7460.5160.332.74
288701488724888713160.17660.22
393404793448293426463.37363.42
488125988128588127259.77859.83
586384986431586408258.61258.66
687426887395387411059.29259.34
480min1151399415141081514051102.701102.000.82102.84102.140.82
2150490215040721504487102.052102.19
3149421514944891494352101.364101.51
4151341915138501513634102.672102.81
5151215515115591511857102.552102.69
6148420414832721483738100.644100.78
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991445126144554014455031445851144630214456640.04
211.141449828144941614496220.03
单位质量响应值RSD%判断
131543.59130127.650.77数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min19642196879966506.5506.303.606.556.303.60
29335593404933806.3286.33
39565795196954266.4676.47
49061590580905986.1406.14
58754487724876345.9395.94
69456294338944506.4016.40
120min140893940909440901627.71926.244.6727.7326.254.67
240004439964139984227.09727.11
337494737451137472925.39525.41
435925235843735884424.31924.33
538695138755738725426.24426.25
639320139374739347426.66626.68
240min194021994088894055463.74158.787.2263.7958.827.22
292757692759392758462.86262.91
382300682256382278455.76055.81
477476677459877468252.50052.55
587308187267787287959.15559.20
686487686548186517858.63358.68
480min1149562614953771495502101.350101.770.51101.50101.910.50
2149706314968981496980101.450101.59
3149708314967691496926101.447101.58
4151263815119121512275102.487102.61
5151158915090911510340102.356102.49
6149802414983891498206101.533101.67
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991428613142844914281791428350142824314283670.02
211.141442804144348014431420.04
单位质量响应值RSD%判断
129969.70129545.960.24数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min19558195649956156.5335.3821.116.535.3821.11
28207682315821965.6175.62
39116590727909466.2146.21
45244952428524383.5833.58
58651186439864755.9095.91
66521865008651134.4494.45
120min138744738759338752026.48024.537.9426.4924.547.94
233957134033733995423.22923.24
337436537441637439025.58225.59
431416331437131426721.47421.48
538415838347238381526.22626.24
635399635400435400024.18924.20
240min183946083906983926457.34853.759.9757.4053.799.97
269183969212569198247.28447.33
383559183580883570057.10457.15
467974867895367935046.42146.46
584422684430384426457.68957.74
682895882846982871456.62756.67
480min1147999814796941479846101.11999.665.07101.2599.785.07
2148429314843441484318101.425101.54
3150441515052761504846102.828102.96
413090911308644130886889.43689.54
5148349714842111483854101.393101.53
6148853014893431488936101.741101.87
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991445261144478314453261445011144443214449630.03
211.141446702144737714470400.04
单位质量响应值RSD%判断
131479.80129895.870.86数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min19186491936919006.2356.268.706.246.268.71
29852298393984586.6806.68
39930999253992816.7366.74
48522885182852055.7815.78
59868598835987606.7016.70
68020380495803495.4515.45
120min134945434912534929023.69825.454.8223.7125.464.81
238117938144338131125.87125.88
339014339068139041226.48826.50
436434836478136456424.73524.74
536720136689636704824.90324.91
639767239780439773826.98526.99
240min180716780678980697854.75156.232.5354.8056.282.54
285217285218685217957.81857.87
384693384707184700257.46757.52
481743481731881737655.45755.50
580643680585380614454.69554.74
684284984294384289657.18857.24
480min1148203714829031482470100.581101.140.69100.71101.280.69
2148384714843401484094100.691100.83
3149470814951461494927101.426101.56
4148304114824781482760100.601100.73
5150881615091341508975102.380102.51
6149093014915641491247101.177101.31
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