非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971888041890831888031884451892401888750.17
210.991871761877721874740.23
单位质量响应值RSD%判断
17217.4117058.600.66数据可信
供试品溶液-25041102批-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%
5min123602-2360212.38513.7450.7212.3813.7450.74
239829-3982920.90020.90
38993-89934.7194.72
435029-3502918.38118.38
537343-3734319.59519.60
612355-123556.4836.48
10min175546-7554639.64242.7440.1839.6642.7740.19
2116624-11662461.19761.23
337589-3758919.72419.73
4104736-10473654.95954.99
5105241-10524155.22455.26
649023-4902325.72425.74
15min1122482-12248264.27166.5017.7064.3666.6017.73
2148826-14882678.09578.23
396468-9646850.62150.66
4146962-14696277.11777.24
5140902-14090273.93774.06
6104762-10476254.97355.03
20min1147145-14714577.21377.659.3977.4177.859.45
2161407-16140784.69784.96
3129526-12952667.96768.09
4160687-16068784.31984.57
5155909-15590981.81282.06
6133170-13317069.88070.02
30min1163968-16396886.04186.855.2486.3687.185.30
2174101-17410191.35891.77
3156268-15626882.00082.24
4173301-17330190.93891.33
5170995-17099589.72890.11
6154438-15443881.04081.30
45min1175483-17548392.08392.423.1892.5592.903.24
2180733-18073394.83895.40
3171181-17118189.82590.20
4181641-18164195.31495.86
5179714-17971494.30394.84
6167967-16796788.13988.54
60min1179148-17914894.00694.312.6894.6394.942.74
2183584-18358496.33497.05
3176100-17610092.40792.93
4184618-18461896.87697.58
5182577-18257795.80596.50
6172306-17230690.41690.96
极限1187563-18756398.42298.170.8199.2098.960.86
2187536-18753698.40899.29
3187338-18733898.30498.98
4187673-18767398.47999.34
5188325-18832598.82299.67
6184074-18407496.59197.29
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971879191874831877531880131871721876680.19
210.991869771873351871560.14
单位质量响应值RSD%判断
17107.3817029.660.33数据可信
供试品溶液-25041102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%
5min137015-3701519.50220.2625.2519.5020.2625.24
250128-5012826.41126.41
343893-4389323.12623.13
423035-2303512.13612.14
532614-3261417.18317.18
644038-4403823.20223.20
10min184753-8475344.65446.129.9844.6946.159.99
2103519-10351954.54154.58
388787-8878746.77946.82
478785-7878541.50941.53
581240-8124042.80342.83
688079-8807946.40646.44
15min1108881-10888157.36658.896.1957.4759.006.20
2124850-12485065.77965.91
3111771-11177158.88859.00
4107294-10729456.53056.62
5105523-10552355.59755.70
6112326-11232659.18159.30
20min1123826-12382665.24066.544.6565.4466.754.66
2137489-13748972.43872.68
3125210-12521065.96966.18
4122893-12289364.74864.93
5121099-12109963.80364.00
6127270-12727067.05467.27
30min1142158-14215874.89875.672.3975.2175.992.41
2149739-14973978.89379.26
3142878-14287875.27875.60
4141131-14113174.35774.65
5140549-14054974.05174.35
6145318-14531876.56376.89
45min1155838-15583882.10682.911.6782.5483.361.69
2161471-16147185.07485.57
3156741-15674182.58283.03
4155533-15553381.94582.36
5154936-15493681.63182.05
6159681-15968184.13184.58
60min1163862-16386286.33487.101.2086.9187.681.22
2167513-16751388.25788.90
3165405-16540587.14687.73
4162741-16274185.74386.29
5164679-16467986.76487.32
6167664-16766488.33788.93
极限1171733-17173390.48090.510.6691.2091.240.68
2173252-17325291.28192.07
3170381-17038189.76890.50
4170553-17055389.85990.55
5172283-17228390.77091.47
6172511-17251190.89091.63
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971861791873461864961871471872271868790.28
210.991865581866491866040.04
单位质量响应值RSD%判断
17035.4616979.440.24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%
5min18800-88004.6533.7979.414.653.7879.41
211433-114336.0456.05
3-0.0000.00
412545-125456.6336.63
5-0.0000.00
610176-101765.3815.38
10min116755-167558.8599.1520.328.879.1520.36
219599-1959910.36310.37
313485-134857.1307.13
421508-2150811.37311.38
512938-129386.8416.84
619512-1951210.31710.33
15min122118-2211811.69511.5415.6011.7211.5615.64
224654-2465413.03613.06
318700-187009.8889.90
425135-2513513.29013.32
516735-167358.8498.86
623635-2363512.49712.52
20min125015-2501513.22712.9012.8513.2712.9412.90
227886-2788614.74514.79
321250-2125011.23611.26
426285-2628513.89813.95
519880-1988010.51210.54
626041-2604113.76913.82
30min130246-3024615.99315.1710.0716.0615.2310.11
231977-3197716.90816.98
326595-2659514.06214.11
430302-3030216.02216.10
524065-2406512.72512.77
628941-2894115.30315.37
45min133993-3399317.97417.327.6918.0617.417.73
236177-3617719.12919.23
331985-3198516.91216.98
433322-3332217.61917.72
528575-2857515.10915.17
632514-3251417.19217.29
60min137054-3705419.59318.656.4519.7118.776.47
238233-3823320.21620.35
334802-3480218.40218.50
435393-3539318.71418.85
531652-3165216.73616.83
634546-3454618.26618.39
极限138935-3893520.58720.500.8420.7420.650.78
238737-3873720.48220.65
339246-3924620.75220.88
438524-3852420.37020.53
538876-3887620.55620.67
638330-3833020.26720.42
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