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500
标示量(mg)20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%
111.193842063839603841703841403842783841510.04
211.173820313824243822280.08
单位质量响应值RSD%判断
34329.8534219.160.23数据可信
供试品溶液-2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%
5min15501-55017.2175.6924.087.225.6924.05
25514-55147.2347.23
33900-39005.1165.12
43629-36294.7614.76
54536-45365.9515.95
62932-29323.8463.85
10min115587-1558720.44817.5131.5420.4917.5431.52
219262-1926225.26925.31
38886-888611.65711.69
412004-1200415.74815.77
515628-1562820.50220.54
68695-869511.40711.43
15min132390-3239042.49239.2727.7842.6539.4027.78
244144-4414457.91258.09
322006-2200628.86928.96
426526-2652634.79934.91
532206-3220642.25042.40
622321-2232129.28329.37
20min142163-4216355.31352.0721.1755.7052.4121.22
253234-5323469.83770.34
331163-3116340.88241.14
435466-3546646.52746.83
543849-4384957.52557.91
632249-3224942.30742.55
30min153357-5335769.99867.5316.2070.7068.1716.28
264962-6496285.22386.11
342033-4203355.14255.62
447754-4775462.64863.21
555705-5570573.07873.78
645048-4504859.09859.58
45min161604-6160480.81779.7612.6481.9080.7812.75
273258-7325896.10697.47
353002-5300269.53270.32
457403-5740375.30676.22
565462-6546285.87886.99
654075-5407570.94071.75
60min167606-6760688.69188.349.3990.2389.809.53
277564-77564101.755103.65
363082-6308282.75683.93
464763-6476384.96186.29
571146-7114693.33594.92
659878-5987878.55379.76
极限180006-80006104.958104.531.92106.99106.472.04
282125-82125107.738110.20
380328-80328105.381107.01
478040-78040102.379104.18
578156-78156102.531104.63
679412-79412104.179105.82
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500
标示量(mg)20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%
111.193826863823363819503817553814553820360.13
211.173813003812223812610.02
单位质量响应值RSD%判断
34140.8434132.590.02数据可信
供试品溶液-2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%
5min14634-46346.1045.1541.446.105.1541.42
26811-68118.9718.97
33747-37474.9354.94
42874-28743.7863.79
52485-24853.2733.27
62892-28923.8093.81
10min113264-1326417.47118.0939.6817.5018.1239.68
224396-2439632.13432.18
313681-1368118.02018.05
49996-999613.16613.19
510595-1059513.95513.97
610463-1046313.78213.80
15min137919-3791949.94639.8522.1350.0839.9822.16
239573-3957352.12552.35
326961-2696135.51235.64
423921-2392131.50831.60
526214-2621434.52834.62
626924-2692435.46435.56
20min149251-4925164.87252.8119.0765.2853.1619.11
250397-5039766.38266.90
335612-3561246.90747.23
433798-3379844.51844.79
534256-3425645.12145.41
637239-3723949.05049.35
30min160874-6087480.18268.9713.0780.9569.6213.15
260584-6058479.80080.69
346200-4620060.85361.44
446356-4635661.05961.58
547883-4788363.07063.61
652283-5228368.86669.43
45min170523-7052392.89180.9110.5794.1181.9410.64
266862-6686288.06989.40
354316-5431671.54472.47
455575-5557573.20274.06
558172-5817276.62377.51
663115-6311583.13384.08
60min174520-7452098.15687.638.3999.8989.108.48
270353-7035392.66794.49
360424-6042479.58980.91
461173-6117380.57681.84
563983-6398384.27785.59
668698-6869890.48791.90
极限182904-82904109.199105.162.71111.47107.122.80
279000-79000104.057106.39
378312-78312103.151104.91
478866-78866103.880105.59
577735-77735102.391104.17
682198-82198108.269110.18
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500
标示量(mg)20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%
111.193823263821053822373821653819423821550.04
211.173818593819313818950.02
单位质量响应值RSD%判断
34151.4734189.350.08数据可信
供试品溶液-2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%
5min14156-41565.4695.443.305.475.443.34
24121-41215.4235.42
34120-41205.4215.42
44147-41475.4575.46
54351-43515.7255.73
63922-39225.1615.16
10min112023-1202315.82118.229.5615.8518.259.54
215695-1569520.65320.68
313294-1329417.49317.52
413413-1341317.65017.68
515056-1505619.81219.84
613601-1360117.89717.93
15min128905-2890538.03537.947.6838.1538.067.67
231674-3167441.67941.82
327037-2703735.57735.70
430529-3052940.17240.30
529187-2918738.40638.55
625643-2564333.74333.87
20min138410-3841050.54349.007.7950.8749.347.77
240444-4044453.21953.60
334810-3481045.80646.13
439552-3955252.04652.40
537333-3733349.12649.48
632872-3287243.25543.57
30min149445-4944565.06363.367.4865.6763.977.47
252887-5288769.59370.26
344278-4427858.26458.84
450596-5059666.57867.22
547965-4796563.11663.74
643715-4371557.52458.08
45min159739-5973978.60977.196.1179.5878.166.12
262922-6292282.79883.86
354102-5410271.19272.09
461120-6112080.42681.44
559560-5956078.37479.35
654512-5451271.73172.61
60min166982-6698288.14085.995.8789.5587.385.88
270561-7056192.85094.37
360553-6055379.68080.98
466149-6614987.04488.50
566734-6673487.81489.23
661098-6109880.39781.67
极限172994-7299496.05196.122.7497.9597.992.77
276472-76472100.628102.66
370363-7036392.58994.33
472214-7221495.02596.97
572709-7270995.67697.58
673515-7351596.73798.46
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500
标示量(mg)20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%
111.193821743818253818913816413817203818500.06
211.173818343821073819700.06
单位质量响应值RSD%判断
34124.2234196.060.15数据可信
供试品溶液-2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%
5min13468-34684.5654.669.374.564.669.34
23163-31634.1634.16
34098-40985.3945.39
43370-33704.4364.44
53745-37454.9294.93
63400-34004.4754.48
10min112275-1227516.15716.679.2416.1816.709.23
213771-1377118.12618.15
313261-1326117.45517.49
412862-1286216.93016.95
513318-1331817.53017.56
610509-1050913.83313.86
15min127984-2798436.83535.526.5736.9535.646.54
227889-2788936.71036.83
325098-2509833.03633.16
429603-2960338.96639.08
525630-2563033.73633.86
625716-2571633.84933.95
20min136305-3630547.78747.236.5848.1147.546.56
236044-3604447.44447.77
333155-3315543.64143.95
440003-4000352.65552.99
534102-3410244.88845.20
635675-3567546.95847.25
30min148769-4876964.19361.606.1864.7862.186.17
246891-4689161.72162.31
343171-4317156.82557.38
450961-5096167.07967.71
544078-4407858.01958.58
646935-4693561.77962.33
45min158825-5882577.43074.884.6278.3775.804.61
255739-5573973.36874.30
353885-5388570.92771.80
460133-6013379.15180.15
554218-5421871.36672.25
658512-5851277.01877.91
60min166657-6665787.73984.314.0889.1185.644.08
263316-6331683.34184.68
360101-6010179.10980.37
465842-6584286.66688.11
562200-6220081.87283.15
666177-6617787.10788.43
极限176206-76206100.30892.685.54102.1794.485.51
271833-7183394.55296.36
365003-6500385.56287.26
472314-7231495.18597.11
567991-6799189.49591.23
669103-6910390.95892.76
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