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%
1 10.831852971848261852941849351846141849930.17
2 10.811836541840701838620.16
单位质量响应值RSD%判断
17081.5317008.510.31数据可信
供试品溶液-BXK5AZ2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%
5min153832-5383228.40128.5310.4028.4028.5310.40
260346-6034631.83831.84
351617-5161727.23327.23
444580-4458023.52023.52
555463-5546329.26229.26
658602-5860230.91830.92
10min1132195-13219569.74567.176.5969.7967.226.59
2133848-13384870.61770.67
3131675-13167569.47169.52
4117476-11747661.98062.02
5115634-11563461.00861.06
6133057-13305770.20070.25
15min1171106-17110690.27487.572.0290.4487.732.02
2165578-16557887.35887.53
3168255-16825588.77088.93
4162201-16220185.57685.72
5162832-16283285.90986.06
6165885-16588587.52087.69
20min1181916-18191695.97894.411.1396.2994.711.14
2178055-17805593.94194.26
3180966-18096695.47695.79
4177942-17794293.88194.17
5176746-17674693.25093.54
6178003-17800393.91394.23
30min1189957-189957100.22098.541.16100.6999.001.16
2184642-18464297.41697.89
3188742-18874299.579100.05
4186802-18680298.55699.00
5185146-18514697.68298.13
6185347-18534797.78898.26
45min1192305-192305101.459100.360.83102.10100.990.83
2188451-18845199.426100.06
3190968-190968100.753101.39
4191339-191339100.949101.56
5188540-18854099.472100.08
6189765-189765100.119100.75
60min1193666-193666102.177100.731.00102.99101.530.99
2188684-18868499.548100.35
3192207-192207101.407102.21
4191686-191686101.132101.91
5189579-189579100.021100.80
6189770-189770100.121100.92
极限1193954-193954102.329100.841.03103.31101.801.03
2189175-18917599.807100.77
3192702-192702101.668102.64
4191605-191605101.090102.03
5189205-18920599.823100.77
6190126-190126100.309101.28
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%
1 10.831834171836981834431835271837491835670.09
2 10.811822551824611823580.08
单位质量响应值RSD%判断
16949.8616869.380.34数据可信
供试品溶液-BXK5AZ2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%
5min152392-5239227.86327.066.0127.8627.066.01
251551-5155127.41627.42
355567-5556729.55229.55
449892-4989226.53326.53
546546-4654624.75424.75
649400-4940026.27226.27
10min1124756-12475666.34866.026.2366.3966.076.23
2124409-12440966.16366.21
3137791-13779173.28073.33
4124438-12443866.17866.22
5115622-11562261.49061.53
6117853-11785362.67662.72
15min1163719-16371987.06987.362.2987.2387.522.30
2162715-16271586.53586.69
3171723-17172391.32591.50
4163824-16382487.12587.28
5161893-16189386.09886.24
6161737-16173786.01586.16
20min1177009-17700994.13794.921.3294.4495.221.32
2177755-17775594.53394.83
3182769-18276997.20097.52
4178153-17815394.74595.04
5179133-17913395.26695.55
6176077-17607793.64193.93
30min1188235-188235100.10799.710.86100.57100.170.87
2187219-18721999.567100.02
3189209-189209100.625101.11
4187338-18733899.630100.09
5188389-188389100.189100.63
6184564-18456498.15598.60
45min1189155-189155100.596100.910.67101.22101.540.68
2189191-189191100.615101.24
3191291-191291101.732102.39
4189981-189981101.035101.66
5190959-190959101.556102.17
6187889-18788999.923100.53
60min1190187-190187101.145101.330.58101.94102.120.57
2191099-191099101.630102.42
3190703-190703101.419102.24
4189922-189922101.004101.80
5192250-192250102.242103.02
6189047-189047100.539101.32
极限1189159-189159100.598101.330.83101.56102.290.83
2190831-190831101.487102.45
3192261-192261102.248103.24
4190392-190392101.254102.21
5192141-192141102.184103.14
6188376-188376100.182101.13
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%
1 10.831833441832681827491832011832201831560.13
2 10.811830821823581827200.29
单位质量响应值RSD%判断
16911.9116902.870.04数据可信
供试品溶液-2025042521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%
5min110296-102965.4764.7025.945.484.7025.92
211887-118876.3236.32
37560-75604.0214.02
46469-64693.4413.44
56501-65013.4583.46
610293-102935.4755.47
10min156368-5636829.98128.807.5829.9928.807.59
260843-6084332.36232.37
353868-5386828.65228.66
450114-5011426.65526.66
549911-4991126.54726.55
653760-5376028.59428.60
15min189264-8926447.47844.333.9847.5444.383.99
284396-8439644.88944.95
381953-8195343.59043.64
480458-8045842.79442.84
580431-8043142.78042.83
683571-8357144.45044.51
20min1107077-10707756.95352.814.1357.0952.944.13
297614-9761451.92052.06
399778-9977853.07153.20
495599-9559950.84850.97
596770-9677051.47151.59
698927-9892752.61852.75
30min1121371-12137164.55661.753.1764.7961.973.17
2112328-11232859.74659.97
3119612-11961263.62063.84
4112667-11266759.92660.13
5114992-11499261.16361.37
6115638-11563861.50661.72
45min1130210-13021069.25767.262.3869.6067.582.38
2123027-12302765.43665.76
3129741-12974169.00769.33
4123835-12383565.86666.17
5126698-12669867.38967.70
6125177-12517766.58066.90
60min1134925-13492571.76570.031.9572.2270.471.95
2128714-12871468.46168.90
3134012-13401271.27971.72
4128865-12886568.54168.96
5132020-13202070.22070.64
6131493-13149369.93970.37
极限1149866-14986679.71278.901.1580.2979.451.15
2146202-14620277.76378.31
3150687-15068780.14880.70
4148566-14856679.02079.55
5147336-14733678.36678.90
6147372-14737278.38578.93
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%
1 10.831836231834991839151838991835821837040.11
2 10.811826311831751829030.22
单位质量响应值RSD%判断
16962.5116919.800.18数据可信
供试品溶液-BXK5AZ2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%
5min15724-57243.0383.8049.333.043.8049.31
25919-59193.1423.14
314146-141467.5097.51
44983-49832.6452.65
54859-48592.5792.58
67373-73733.9143.91
10min126418-2641814.02317.4634.0114.0317.4634.00
228133-2813314.93414.94
355498-5549829.46029.47
427073-2707314.37114.38
529920-2992015.88215.89
630276-3027616.07116.08
15min148106-4810625.53628.1916.2725.5628.2316.29
246666-4666624.77224.80
368721-6872136.47936.54
445909-4590924.37024.40
552852-5285228.05528.09
656432-5643229.95629.99
20min164249-6424934.10534.3010.6634.1834.3810.68
257105-5710530.31330.38
373803-7380339.17739.30
456330-5633029.90129.97
566841-6684135.48135.56
669322-6932236.79836.88
30min178940-7894041.90340.126.2942.0340.266.30
273000-7300038.75038.87
377898-7789841.35041.54
466970-6697035.54935.67
578324-7832441.57641.71
678381-7838141.60741.75
45min185802-8580245.54643.184.8645.7443.394.85
282133-8213343.59843.78
380451-8045142.70642.96
474126-7412639.34839.53
583305-8330544.22144.43
682284-8228443.67943.89
60min188806-8880647.14144.724.3647.4145.004.35
285535-8553545.40445.66
382513-8251343.80044.13
477993-7799341.40141.64
585848-8584845.57045.85
684821-8482145.02545.31
极限1134868-13486871.59270.341.6671.9470.691.68
2132263-13226370.20970.54
3132711-13271170.44770.85
4128577-12857768.25268.56
5132424-13242470.29470.65
6134205-13420571.24071.60
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