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%
1 11.063811483814883819273807733815523813780.12
2 11.073803673801643802660.04
单位质量响应值RSD%判断
34482.6434351.040.28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%
5min193078-9307824.32124.1831.3724.3224.1831.37
291468-9146823.90023.90
3112751-11275129.46129.46
438552-3855210.07310.07
597398-9739825.44925.45
6121900-12190031.85131.85
10min1226052-22605259.06657.7520.7859.1157.7920.79
2235157-23515761.44561.48
3238534-23853462.32762.38
4129179-12917933.75333.77
5243291-24329163.57063.61
6253937-25393766.35266.40
15min1273755-27375571.53071.7612.0071.6771.8912.02
2284303-28430374.28674.43
3285525-28552574.60574.76
4209879-20987954.84054.91
5298628-29862878.02978.18
6295640-29564077.24877.41
20min1300248-30024878.45279.586.2478.7179.836.27
2309369-30936980.83681.10
3312559-31255981.66981.95
4268548-26854870.16970.33
5321502-32150284.00684.28
6315124-31512482.33982.63
30min1328696-32869685.88687.352.6686.2787.742.70
2333642-33364287.17887.58
3340846-34084689.06089.47
4321299-32129983.95384.23
5346590-34659090.56190.98
6334695-33469587.45387.88
45min1353751-35375192.43293.642.1592.9694.172.19
2367294-36729495.97196.52
3362131-36213194.62295.18
4345640-34564090.31390.73
5362758-36275894.78695.35
6358703-35870393.72694.30
60min1368663-36866396.32996.131.7797.0196.821.80
2369653-36965396.58797.29
3373545-37354597.60498.32
4358005-35800593.54494.12
5374925-37492597.96598.69
6362547-36254794.73195.46
极限1372821-37282197.41597.851.5598.2698.701.58
2377016-37701698.51199.38
3379602-37960299.187100.07
4366889-36688995.86596.59
5381333-38133399.639100.53
6369181-36918196.46497.35
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%
1 11.063771393772423803693801583773943784600.44
2 11.073768313787673777990.37
单位质量响应值RSD%判断
34218.8134128.180.19数据可信
供试品溶液-t2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%
5min167092-6709217.65517.086.9517.6617.086.96
256403-5640314.84314.84
363648-6364816.74916.75
468924-6892418.13718.14
566386-6638617.47017.47
667084-6708417.65317.65
10min1110417-11041729.05628.153.8429.0928.183.84
2101182-10118226.62626.65
3104852-10485227.59227.62
4112762-11276229.67429.70
5106359-10635927.98928.02
6106358-10635827.98828.02
15min1134178-13417835.30934.472.7635.3934.542.77
2127687-12768733.60133.67
3128800-12880033.89433.97
4136758-13675835.98836.07
5129068-12906833.96434.04
6129409-12940934.05434.13
20min1150344-15034439.56338.762.4239.7038.902.42
2145343-14534338.24738.37
3145237-14523738.21938.35
4153116-15311640.29340.43
5144438-14443838.00938.14
6145334-14533438.24538.38
30min1172563-17256345.41044.641.9345.6144.841.93
2168463-16846344.33144.52
3168810-16881044.42344.62
4174410-17441045.89646.10
5165447-16544743.53843.73
6168112-16811244.23944.44
45min1193129-19312950.82250.701.8051.1050.971.80
2192450-19245050.64450.91
3191315-19131550.34550.61
4197389-19738951.94352.23
5187038-18703849.21949.49
6194653-19465351.22351.49
60min1208957-20895754.98754.791.6255.3555.151.61
2210442-21044255.37855.73
3207704-20770454.65855.01
4212254-21225455.85556.22
5202419-20241953.26753.62
6207449-20744954.59154.95
极限1220449-22044958.01258.291.3758.4758.741.36
2224225-22422559.00559.44
3219638-21963857.79858.24
4225461-22546159.33059.79
5217284-21728457.17957.62
6222013-22201358.42358.87
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%
1 11.063777713789393805133774473801513789640.37
2 11.073771673795983783820.46
单位质量响应值RSD%判断
34264.3834180.850.18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%
5min1168255-16825544.21329.6956.4344.2129.6956.42
250330-5033013.22513.23
351212-5121213.45713.46
464636-6463616.98516.98
5183541-18354148.23048.23
6159982-15998242.03942.04
10min1266058-26605869.91356.4528.2469.9956.5028.26
2139736-13973636.71936.74
3150196-15019639.46839.49
4197179-19717951.81451.84
5269928-26992870.93071.01
6265846-26584669.85769.93
15min1296672-29667277.95868.8516.1778.1568.9916.21
2204217-20421753.66353.75
3217199-21719957.07457.16
4260409-26040968.42968.54
5297555-29755578.19078.39
6296020-29602077.78677.97
20min1315060-31506082.79076.2310.3583.1176.4910.41
2250183-25018365.74265.91
3256486-25648667.39867.58
4290788-29078876.41276.64
5315398-31539882.87883.21
6312750-31275082.18382.50
30min1334726-33472687.95783.755.4988.4284.145.56
2294770-29477077.45877.74
3300195-30019578.88379.18
4318835-31883583.78284.14
5333282-33328287.57888.04
6330591-33059186.87187.32
45min1348008-34800891.44789.163.2392.0589.683.31
2323292-32329284.95385.36
3327707-32770786.11386.54
4342567-34256790.01890.51
5347756-34775691.38191.99
6346394-34639491.02391.62
60min1355410-35541093.39391.702.6494.1592.382.72
2336669-33666988.46889.02
3338260-33826088.88689.46
4351074-35107492.25392.90
5357651-35765193.98194.75
6354859-35485993.24894.00
极限1360679-36067994.77794.180.8095.6995.010.90
2356188-35618893.59794.30
3354094-35409493.04793.77
4357929-35792994.05494.85
5361059-36105994.87795.80
6360608-36060894.75895.66
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%
1 11.063772553774533789183770343774483776220.20
2 11.073766483772933769700.13
单位质量响应值RSD%判断
34143.0434053.300.19数据可信
供试品溶液-t2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%
5min162305-6230516.43214.6712.2916.4314.6712.31
245516-4551612.00412.00
356428-5642814.88214.88
458682-5868215.47615.48
561563-6156316.23616.24
649190-4919012.97312.97
10min1103357-10335727.25926.186.0927.2926.206.10
288208-8820823.26323.28
3100978-10097826.63126.66
4100629-10062926.53926.56
5105139-10513927.72927.76
697292-9729225.65925.68
15min1125184-12518433.01532.344.0033.0932.414.02
2112939-11293929.78629.84
3126107-12610733.25933.33
4124393-12439332.80732.88
5124770-12477032.90632.98
6122427-12242732.28832.35
20min1142419-14241937.56136.643.2037.6936.763.20
2130501-13050134.41734.53
3142032-14203237.45937.58
4140855-14085537.14837.27
5139894-13989436.89537.02
6137934-13793436.37836.50
30min1162461-16246142.84642.312.1343.0442.502.14
2153791-15379140.56040.73
3163226-16322643.04843.24
4161825-16182542.67942.87
5160605-16060542.35742.55
6160692-16069242.38042.56
45min1184749-18474948.72447.962.1548.9948.212.16
2174306-17430645.97046.20
3184699-18469948.71148.97
4183406-18340648.37048.63
5181813-18181347.95048.21
6182077-18207748.02048.27
60min1199412-19941252.59251.962.3252.9352.292.32
2188832-18883249.80150.11
3197951-19795152.20652.55
4202419-20241953.38553.72
5196120-19612051.72352.06
6197383-19738352.05652.39
极限1214039-21403956.44955.561.2956.8855.981.30
2205974-20597454.32254.72
3211254-21125455.71556.14
4211618-21161855.81156.24
5209561-20956155.26855.69
6211577-21157755.80056.22
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