非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.151924121922541923771920651923061922830.08
211.221895011895351895180.02
单位质量响应值RSD%判断
17245.1116891.091.47数据可信
供试品溶液-25040101批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14663-466312.28510.5917.4112.2910.6017.40
22876-28767.5777.58
34297-429711.32111.32
43864-386410.18010.18
54738-473812.48312.48
63688-36889.7179.72
10min113040-1304034.35630.168.7134.4230.228.72
210186-1018626.83726.88
311268-1126829.68729.75
411290-1129029.74529.80
512069-1206931.79831.87
610822-1082228.51228.57
15min117593-1759346.35242.479.2246.6142.709.21
214826-1482639.06239.25
314631-1463138.54838.78
416110-1611042.44542.67
518213-1821347.98548.23
615354-1535440.45340.67
20min121123-2112355.65251.557.8456.1752.017.84
218734-1873449.35849.77
317957-1795747.31147.75
419494-1949451.36051.82
521711-2171157.20157.71
618371-1837148.40248.84
30min126508-2650869.84064.516.6370.6765.266.65
223004-2300460.60861.29
323378-2337861.59362.30
424510-2451064.57665.32
526412-2641269.58770.42
623096-2309660.85061.56
45min131470-3147082.91377.745.3284.1378.845.34
227878-2787873.44974.47
329024-2902476.46977.52
430668-3066880.80081.90
530350-3035079.96281.18
627642-2764272.82873.87
60min135640-3564093.90090.254.7795.5791.794.75
233610-3361088.55189.98
334948-3494892.07793.55
435699-3569994.05595.61
534268-3426890.28591.95
631356-3135682.61384.06
极限139716-39716104.639101.901.51106.83103.941.54
238840-38840102.331104.25
338270-38270100.829102.81
438787-38787102.191104.26
538209-38209100.668102.83
638235-38235100.737102.64
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.151897911901871900121900631899091899920.08
211.221892591889281890940.13
单位质量响应值RSD%判断
17039.6416853.300.78数据可信
供试品溶液-25041101批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13985-398510.57411.9232.5010.5711.9232.49
27331-733119.45219.45
33063-30638.1278.13
44065-406510.78610.79
54226-422611.21311.21
64285-428511.37011.37
10min113194-1319435.00937.2526.2635.0737.3126.27
221353-2135356.65856.77
311116-1111629.49529.54
412763-1276333.86533.92
513569-1356936.00436.07
612227-1222732.44332.51
15min118415-1841548.86250.9822.8449.1251.2622.87
227954-2795474.17274.60
316021-1602142.51042.72
417395-1739546.15546.40
518606-1860649.36949.63
616899-1689944.83945.08
20min122222-2222258.96360.3119.3059.4960.8619.35
231372-3137283.24284.08
319363-1936351.37751.82
420302-2030253.86954.37
522324-2232459.23459.77
620784-2078455.14855.64
30min127439-2743972.80672.3914.7273.6673.2814.82
235044-3504492.98594.28
324350-2435064.61065.34
424722-2472265.59766.40
527125-2712571.97372.84
625006-2500666.35067.15
45min134935-3493592.69686.639.2893.9587.929.41
237429-3742999.313101.13
329598-2959878.53579.62
430246-3024680.25481.42
532691-3269186.74288.01
630999-3099982.25283.42
60min137512-3751299.53394.197.10101.3195.977.23
238616-38616102.463104.83
332707-3270786.78488.31
434048-3404890.34291.96
537013-3701398.20999.96
633099-3309987.82489.45
极限139195-39195103.999103.531.86106.32105.831.64
238007-38007100.847103.78
339142-39142103.858105.87
440102-40102106.406108.52
539222-39222104.071106.36
638440-38440101.996104.11
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.151892981890481892771893651891061892190.08
211.221892181891121891650.04
单位质量响应值RSD%判断
16970.3116859.630.47数据可信
供试品溶液-25041102批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13985-398510.5939.5812.0210.599.5811.99
23767-376710.01410.01
33443-34439.1529.15
43291-32918.7488.75
54135-413510.99210.99
63004-30047.9857.99
10min113019-1301934.60830.9911.6434.6731.0411.65
212490-1249033.20233.26
310856-1085628.85828.91
410378-1037827.58727.64
513078-1307834.76534.83
610122-1012226.90726.95
15min118378-1837848.85444.719.0649.1044.939.07
218173-1817348.30948.55
316640-1664044.23444.44
415095-1509540.12740.33
517688-1768847.01947.27
614930-1493039.68839.88
20min122290-2229059.25355.269.5259.7855.739.53
223191-2319161.64862.16
321016-2101655.86656.32
418605-1860549.45749.88
521366-2136656.79757.31
618260-1826048.54048.95
30min128128-2812874.77269.308.6475.6270.088.65
228646-2864676.14977.00
326190-2619069.62070.39
423625-2362562.80263.50
526607-2660770.72871.56
623213-2321361.70662.39
45min133829-3382989.92683.447.7391.1984.607.75
234153-3415390.78892.06
331797-3179784.52585.68
428487-2848775.72676.77
531360-3136083.36384.59
628698-2869876.28777.31
60min137545-3754599.80592.526.79101.5794.156.81
236879-3687998.03499.81
336073-3607395.89297.52
432007-3200785.08386.55
533947-3394790.24091.93
632373-3237386.05687.51
极限139269-39269104.387101.633.42106.71103.783.44
237630-37630100.031102.35
340324-40324107.192109.35
437496-3749699.674101.62
537881-37881100.698102.89
636794-3679497.80899.74
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