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)0
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%
111.023838573845543845993843163837713842190.11
211.113831333831743831540.01
单位质量响应值RSD%判断
34865.6134487.310.78数据可信
供试品溶液-25082601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%
5min113253-132533.4373.6723.683.443.6723.71
219786-197865.1315.13
315653-156534.0594.06
411201-112012.9052.90
510612-106122.7522.75
614360-143603.7243.72
10min123168-231686.0086.5112.216.016.5112.22
229882-298827.7507.76
327147-271477.0407.05
422652-226525.8755.88
521985-219855.7025.71
625709-257096.6676.67
15min129393-293937.6238.4010.097.648.4210.10
235856-358569.2999.32
335698-356989.2589.28
430528-305287.9177.93
528587-285877.4147.43
634269-342698.8878.90
20min131864-318648.2649.097.648.299.127.68
237902-379029.8309.87
337956-379569.8449.88
434026-340268.8248.85
532412-324128.4068.43
636057-360579.3519.38
30min139596-3959610.26911.257.1810.3111.307.20
245497-4549711.79911.85
347876-4787612.41612.47
443948-4394811.39811.44
540371-4037110.47010.51
643082-4308211.17311.22
45min147905-4790512.42413.296.2912.4813.366.31
252650-5265013.65413.73
356569-5656914.67114.74
450803-5080313.17513.24
548051-4805112.46212.52
651573-5157313.37513.44
60min157832-5783214.99815.734.9715.0815.824.97
260815-6081515.77215.87
365451-6545116.97417.07
462585-6258516.23116.31
557480-5748014.90714.99
659863-5986315.52515.61
极限169271-6927117.96518.592.6018.0718.702.62
273329-7332919.01719.14
373598-7359819.08719.21
472077-7207718.69318.80
569546-6954618.03618.14
672248-7224818.73718.85
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)0
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%
111.023821023820103811163816793814393816690.11
211.113826093827043826560.02
单位质量响应值RSD%判断
34634.2134442.480.40数据可信
供试品溶液-25082601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%
5min1165601-16560143.11836.1223.6843.1236.1223.68
292216-9221624.01124.01
3106505-10650527.73127.73
4166884-16688443.45243.45
5164610-16461042.86042.86
6136441-13644135.52635.53
10min1231757-23175760.34358.225.2360.4258.285.25
2207408-20740854.00454.04
3213127-21312755.49355.54
4236957-23695761.69761.77
5231302-23130260.22560.30
6221147-22114757.58157.64
15min1259438-25943867.55167.282.0167.7267.432.03
2251531-25153165.49265.62
3257510-25751067.04967.19
4266763-26676369.45869.63
5260165-26016567.74067.91
6254935-25493566.37866.53
20min1277636-27763672.28972.161.2872.5772.421.29
2272661-27266170.99471.23
3278578-27857872.53472.78
4282136-28213673.46173.75
5278328-27832872.46972.75
6273477-27347771.20671.47
30min1297414-29741477.43977.800.9877.8478.180.98
2297695-29769577.51277.87
3302002-30200278.63379.00
4302567-30256778.78079.19
5297989-29798977.58877.99
6295046-29504676.82277.21
45min1314470-31447081.88082.450.8682.4182.970.86
2314884-31488481.98782.47
3320259-32025983.38783.89
4319788-31978883.26483.81
5316396-31639682.38182.92
6314244-31424481.82182.33
60min1323825-32382584.31585.040.9984.9985.700.99
2324826-32482684.57685.20
3331195-33119586.23486.88
4330157-33015785.96486.65
5325437-32543784.73585.41
6324128-32412884.39485.04
极限1332128-33212886.47787.030.7487.2987.830.73
2335228-33522887.28488.05
3338271-33827188.07788.86
4335253-33525387.29188.12
5332742-33274286.63787.45
6331919-33191986.42387.21
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)0
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%
111.023806033803103807563805053805273805400.05
211.113818233810203814220.15
单位质量响应值RSD%判断
34531.7634331.410.42数据可信
供试品溶液-25082601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%
5min170842-7084218.50321.4315.9618.5021.4315.97
299080-9908025.87825.88
372483-7248318.93118.93
486311-8631122.54322.54
568966-6896618.01318.01
694720-9472024.73924.74
10min1130412-13041234.06135.416.7334.0935.446.75
2149525-14952539.05339.10
3125664-12566432.82132.85
4138536-13853636.18336.22
5128065-12806533.44833.48
6141178-14117836.87336.91
15min1158986-15898641.52442.534.1541.6142.624.16
2174466-17446645.56745.68
3156898-15689840.97941.07
4164694-16469443.01543.11
5156975-15697540.99941.08
6164897-16489743.06843.17
20min1176997-17699746.22846.923.0946.3947.093.10
2189239-18923949.42649.61
3175797-17579745.91546.07
4182337-18233747.62347.79
5173970-17397045.43845.59
6179618-17961846.91347.09
30min1199847-19984752.19652.691.9052.4352.931.91
2208468-20846854.44854.71
3199584-19958452.12852.36
4203949-20394953.26853.52
5198251-19825151.77952.01
6200213-20021352.29252.54
45min1219091-21909157.22257.701.3857.5458.041.40
2225928-22592859.00859.37
3220980-22098057.71658.03
4222960-22296058.23358.57
5218599-21859957.09457.41
6218042-21804256.94857.29
60min1232320-23232060.67860.891.2261.0961.311.23
2237443-23744362.01662.47
3233747-23374761.05061.46
4234772-23477261.31861.75
5230784-23078460.27660.69
6229630-22963059.97560.41
极限1238806-23880662.37262.790.8562.8963.320.87
2243093-24309363.49164.05
3241284-24128463.01963.53
4242213-24221363.26163.80
5238283-23828362.23562.75
6238812-23881262.37362.91
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