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500
标示量(mg)20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%
111.053784233785403786203779413774473781940.14
211.123799093783243791160.30
单位质量响应值RSD%判断
34225.7034093.170.28数据可信
供试品溶液-1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%
5min151612-5161213.58712.678.9113.5912.678.92
244978-4497811.84111.84
353618-5361814.11614.12
445737-4573712.04112.04
542663-4266311.23111.23
650112-5011213.19313.19
10min1136282-13628235.87835.107.1535.9035.137.16
2130426-13042634.33634.36
3146214-14621438.49238.52
4135362-13536235.63535.66
5117052-11705230.81530.83
6134715-13471535.46535.49
15min1221686-22168658.36157.316.1258.4457.386.12
2213547-21354756.21956.30
3233738-23373861.53461.62
4222270-22227058.51558.59
5193956-19395651.06151.13
6220874-22087458.14758.23
20min1294205-29420577.45375.873.8177.6376.053.81
2281270-28127074.04774.22
3299370-29937078.81279.00
4294554-29455477.54477.72
5269544-26954470.96071.12
6290318-29031876.42976.61
30min1339899-33989989.48288.871.1789.7989.171.18
2333103-33310387.69387.99
3343950-34395090.54890.87
4337787-33778788.92689.23
5334593-33459388.08588.36
6336083-33608388.47788.78
45min1362673-36267395.47895.071.0995.9495.521.09
2355955-35595593.70994.15
3367117-36711796.64797.12
4361968-36196895.29295.75
5361136-36113695.07395.49
6357871-35787194.21394.67
60min1374173-37417398.50597.871.0499.1298.481.04
2366925-36692596.59797.19
3377078-37707899.27099.90
4372352-37235298.02698.64
5372135-37213597.96898.55
6367834-36783496.83697.45
极限1381500-381500100.43499.880.92101.22100.660.93
2374720-37472098.64999.41
3384017-384017101.097101.90
4379904-379904100.014100.79
5380348-380348100.131100.87
6375927-37592798.96799.74
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500
标示量(mg)20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%
111.053811813817473806613808763804543809840.14
211.123801283800063800670.03
单位质量响应值RSD%判断
34478.1934178.690.62数据可信
供试品溶液-2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%
5min124262-242626.3566.8044.786.366.8044.76
218195-181954.7674.77
325402-254026.6556.65
420237-202375.3015.30
518793-187934.9234.92
648948-4894812.82312.82
10min198116-9811625.70321.3338.0125.7121.3438.01
248866-4886612.80112.81
388391-8839123.15623.17
458152-5815215.23415.24
563281-6328116.57816.59
6131710-13171034.50434.53
15min1181820-18182047.63141.0829.5147.6841.1229.52
299510-9951026.06826.10
3170492-17049244.66444.71
4124338-12433832.57332.61
5136201-13620135.68035.72
6228427-22842759.84159.92
20min1269525-26952570.60761.9220.5470.7462.0320.56
2163495-16349542.83142.90
3266890-26689069.91770.04
4212398-21239855.64255.73
5212162-21216255.58055.68
6293612-29361276.91777.10
30min1322252-32225284.42078.3310.3084.6778.5510.34
2255021-25502166.80766.95
3323929-32392984.85985.10
4278416-27841672.93673.12
5284007-28400774.40174.59
6330480-33048086.57586.88
45min1349414-34941491.53587.596.0791.9387.946.12
2306568-30656880.31180.57
3349709-34970991.61391.99
4317259-31725983.11283.41
5327042-32704285.67585.99
6356103-35610393.28893.74
60min1360040-36004094.31991.174.5794.8691.664.63
2326924-32692485.64486.03
3362506-36250694.96595.50
4334720-33472087.68688.13
5340591-34059189.22489.68
6363242-36324295.15895.76
极限1368819-36881996.61994.882.7497.3295.522.81
2350734-35073491.88192.41
3372747-37274797.64898.34
4351106-35110691.97992.57
5358982-35898294.04294.65
6370649-37064997.09897.86
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