培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.381955719586197901964719813196790.60
210.351948319392194380.34
单位质量响应值RSD%判断
1895.861878.070.67数据可信
供试品溶液-1批-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%
5min122258-22258100.643103.721.85100.64103.721.85
223113-23113104.509104.51
323069-23069104.310104.31
422692-22692102.605102.61
522994-22994103.971103.97
623503-23503106.272106.27
10min123299-23299105.350106.011.02106.47107.161.03
223415-23415105.875107.04
323344-23344105.553106.71
423277-23277105.251106.39
523415-23415105.875107.03
623918-23918108.149109.33
15min122809-22809103.134104.941.66105.42107.271.65
223571-23571106.580108.92
322860-22860103.365105.70
423067-23067104.301106.61
523176-23176104.794107.13
623762-23762107.444109.83
20min122740-22740102.822103.941.81106.26107.441.79
223479-23479106.164109.69
322639-22639102.366105.85
422653-22653102.429105.90
522873-22873103.424106.92
623544-23544106.458110.03
30min122469-22469101.597102.901.14106.17107.551.15
222956-22956103.799108.50
322808-22808103.130107.75
422456-22456101.538106.14
522754-22754102.886107.53
623099-23099104.446109.20
45min121939-2193999.201101.161.86104.91106.961.82
222292-22292100.797106.65
322618-22618102.271108.03
421938-2193899.196104.93
522434-22434101.439107.23
623016-23016104.070109.99
极限121951-2195199.255100.661.32106.06107.581.32
222406-22406101.312108.29
322524-22524101.846108.75
421971-2197199.345106.18
522093-2209399.897106.81
622623-22623102.293109.37
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.381949519572195661970319468195610.47
210.351964519398195220.90
单位质量响应值RSD%判断
1884.491886.180.07数据可信
供试品溶液-2批-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%
5min17381-738133.40233.853.1933.4033.863.19
27675-767534.73334.73
37077-707732.02732.03
47694-769434.81934.82
57422-742233.58833.59
67636-763634.55634.56
10min118945-1894585.73589.866.7186.1190.246.69
221020-2102095.12595.51
319737-1973789.31989.67
420765-2076593.97194.36
517709-1770980.14180.51
620968-2096894.89095.27
15min123596-23596106.783107.220.37108.11108.600.39
223658-23658107.063108.51
323835-23835107.864109.21
423705-23705107.276108.71
523626-23626106.918108.18
623736-23736107.416108.85
20min123073-23073104.416105.981.33106.93108.551.32
223523-23523106.452109.08
323696-23696107.235109.78
423816-23816107.778110.40
523308-23308105.479107.93
623100-23100104.538107.17
30min122842-22842103.370105.021.40107.04108.761.39
223295-23295105.420109.24
323696-23696107.235110.97
423422-23422105.995109.82
522954-22954103.877107.50
623028-23028104.212108.01
45min123040-23040104.266103.430.91109.09108.340.89
222754-22754102.972107.96
323090-23090104.493109.42
422966-22966103.932108.93
522578-22578102.176106.95
622698-22698102.719107.67
极限122553-22553102.063102.760.90108.04108.820.89
222994-22994104.058110.19
322721-22721102.823108.91
422864-22864103.470109.62
522685-22685102.660108.57
622432-22432101.515107.61
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.381929619670195191948819389194720.73
210.351958619479195320.39
单位质量响应值RSD%判断
1875.921887.150.43数据可信
供试品溶液-3批-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%
5min14869-486922.07922.462.9622.0822.462.96
25130-513023.26323.26
35000-500022.67322.67
44984-498422.60122.60
55029-502922.80522.80
64709-470921.35421.35
10min19481-948142.99343.034.4543.2443.284.44
29951-995145.12445.38
39855-985544.68944.94
49617-961743.61043.86
59213-921341.77842.03
68818-881839.98640.22
15min113999-1399963.48065.044.8864.2065.774.87
215051-1505168.25169.01
315264-1526469.21769.97
414395-1439565.27666.01
513873-1387362.90963.63
613473-1347361.09561.78
20min118187-1818782.47284.223.8883.9085.663.88
219241-1924187.25188.77
319528-1952888.55290.07
418551-1855184.12285.58
518367-1836783.28884.70
617556-1755679.61080.97
30min123284-23284105.585104.661.99107.93107.041.89
222776-22776103.281105.77
322755-22755103.186105.69
423409-23409106.151108.55
522534-22534102.184104.53
623719-23719107.557109.80
45min123524-23524106.673103.841.76110.19107.391.70
222681-22681102.850106.49
322653-22653102.723106.37
423265-23265105.498109.07
522492-22492101.993105.47
622783-22783103.313106.75
极限123281-23281105.571104.251.21110.27108.951.13
222547-22547102.243107.02
322847-22847103.603108.39
423222-23222105.303110.05
522901-22901103.848108.46
623142-23142104.941109.53
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