非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.891883456188304218824361883587188357818832200.03
29.971915529191588919157090.02
单位质量响应值RSD%判断
190416.58192147.340.64数据可信
稳定性36月-长期36月-供试品溶液-2012702批-20mg规格-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1549625-54962525.86121.0713.2725.8621.0713.27
2375171-37517117.65317.65
3477123-47712322.45022.45
4430217-43021720.24320.24
5426702-42670220.07720.08
6428314-42831420.15320.15
10min11021917-102191748.08346.884.0048.1346.924.00
2943845-94384544.41044.44
31022107-102210748.09248.13
4975744-97574445.91145.94
51047297-104729749.27749.31
6967556-96755645.52545.56
15min11272071-127207159.85359.492.4759.9859.602.48
21231036-123103657.92358.03
31291110-129111060.74960.87
41253108-125310858.96159.07
51306726-130672661.48461.60
61231880-123188057.96258.07
20min11444912-144491267.98668.031.6468.2168.241.64
21412801-141280166.47566.67
31467195-146719569.03469.25
41430901-143090167.32767.54
51477408-147740869.51569.73
61441717-144171767.83668.04
30min11658864-165886478.05378.621.3978.3978.951.40
21645256-164525677.41277.72
31692548-169254879.63879.97
41664121-166412178.30078.62
51706103-170610380.27580.61
61659260-165926078.07178.39
45min11850353-185035387.06387.881.1087.5388.341.10
21841747-184174786.65887.10
31887206-188720688.79789.26
41864008-186400887.70588.16
51894647-189464789.14789.61
61868428-186842887.91388.36
60min11951692-195169291.83192.911.0092.4493.521.00
21950855-195085591.79192.38
31989523-198952393.61194.23
41974902-197490292.92393.52
51997881-199788194.00494.62
61982903-198290393.29993.90
极限12021903-202190395.13496.270.9695.9097.020.96
22023394-202339495.20595.94
32056328-205632896.75497.52
42047391-204739196.33497.09
52070147-207014797.40498.18
62056468-205646896.76197.51
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.891896896189829118963421897393189670418971250.04
29.971926318192726119267900.04
单位质量响应值RSD%判断
191822.55193258.780.53数据可信
稳定性36月-长期36月-供试品溶液-2012702批-20mg规格-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1466991-46699121.82922.599.5921.8322.599.59
2432129-43212920.19920.20
3557908-55790826.07926.08
4479567-47956722.41722.42
5447773-44777320.93120.93
6514933-51493324.07024.07
10min1973210-97321045.49245.883.6245.5345.923.63
2942629-94262944.06244.10
31042334-104233448.72348.77
4992168-99216846.37846.42
5951845-95184544.49344.53
6987067-98706746.13946.18
15min11244040-124404058.15158.451.8758.2658.561.88
21225426-122542657.28157.39
31288623-128862360.23560.36
41256445-125644558.73158.85
51228361-122836157.41957.53
61259617-125961758.88059.00
20min11420253-142025366.38866.591.2366.6066.801.24
21405573-140557365.70265.90
31452315-145231567.88768.11
41430558-143055866.87067.08
51407300-140730065.78365.99
61431587-143158766.91867.13
30min11647501-164750177.01177.140.7277.3377.460.73
21646108-164610876.94677.26
31667390-166739077.94178.28
41656347-165634777.42477.75
51631893-163189376.28176.60
61652217-165221777.23177.56
45min11840393-184039386.02786.030.5486.4886.480.54
21838867-183886785.95686.40
31857967-185796786.84987.32
41840832-184083286.04886.50
51828175-182817585.45685.90
61836137-183613785.82886.28
60min11939984-193998490.68390.700.6491.2791.290.65
21944880-194488090.91291.50
31957599-195759991.50692.12
41943852-194385290.86391.46
51920036-192003689.75090.33
61935761-193576190.48591.08
极限12006081-200608193.77294.030.5194.5194.780.51
22019395-201939594.39595.13
32025973-202597394.70295.47
42011489-201148994.02594.77
51997235-199723593.35994.09
62009817-200981793.94794.70
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.891916894191610519146441913022191151119144350.12
29.971941509194014319408260.05
单位质量响应值RSD%判断
193572.80194666.600.40数据可信
稳定性36月-长期36月-供试品溶液-2012703批-20mg规格-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1480653-48065322.28522.5118.5622.2822.5118.56
2598528-59852827.75027.75
3566576-56657626.26826.27
4351311-35131116.28816.29
5429042-42904219.89219.89
6486954-48695422.57722.58
10min11008443-100844346.75547.505.1446.7947.545.15
21091748-109174850.61750.66
31079911-107991150.06850.11
4958408-95840844.43544.46
51024243-102424347.48847.52
6984190-98419045.63145.67
15min11296153-129615360.09460.762.4060.2160.882.41
21355863-135586362.86362.99
31336329-133632961.95762.08
41273753-127375359.05659.16
51315532-131553260.99361.10
61285650-128565059.60759.72
20min11488814-148881469.02769.261.7669.2469.481.77
21534467-153446771.14371.38
31505977-150597769.82270.05
41457602-145760267.58067.78
51499028-149902869.50069.71
61477726-147772668.51368.73
30min11715978-171597879.55979.961.1179.8980.301.12
21760873-176087381.64081.99
31720441-172044179.76680.11
41709172-170917279.24379.56
51729498-172949880.18680.52
61712458-171245879.39679.72
45min11903042-190304288.23288.841.2888.6989.301.28
21951263-195126390.46790.96
31892917-189291787.76288.24
41891673-189167387.70588.15
51922196-192219689.12089.58
61935872-193587289.75490.21
60min11994349-199434992.46592.921.2893.0793.531.28
22053129-205312995.19095.83
31987476-198747692.14692.77
41984229-198422991.99692.59
52009320-200932093.15993.77
61995922-199592292.53893.15
极限12058664-205866495.44795.631.5196.2196.401.52
22119745-211974598.27999.08
32042937-204293794.71895.50
42029577-202957794.09894.84
52067849-206784995.87396.64
62056468-205646895.34596.11
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.891919596192028419203961920553192017319202000.02
29.971952726195322419529750.02
单位质量响应值RSD%判断
194155.71195885.160.63数据可信
稳定性36月-长期36月-供试品溶液-2012703批-20mg规格-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1565107-56510726.08025.0517.2226.0825.0517.22
2428838-42883819.79119.79
3459152-45915221.19021.19
4512474-51247423.65123.65
5621521-62152128.68328.68
6669509-66950930.89830.90
10min11086629-108662950.14848.923.2950.1948.963.30
21023910-102391047.25347.29
31020358-102035847.08947.12
41052137-105213748.55648.60
51108435-110843551.15451.20
61069108-106910849.33949.39
15min11337364-133736461.71961.231.3961.8561.361.40
21309035-130903560.41260.52
31313131-131313160.60160.71
41314381-131438160.65960.78
51356828-135682862.61862.75
61330159-133015961.38761.52
20min11503014-150301469.36469.431.0369.5969.661.04
21493571-149357168.92869.14
31496841-149684169.07969.29
41494360-149436068.96569.19
51534673-153467370.82571.06
61504390-150439069.42769.66
30min11719975-171997579.37779.490.4379.7279.830.43
21719082-171908279.33579.66
31728061-172806179.75080.08
41721682-172168279.45579.79
51733206-173320679.98780.34
61712109-171210979.01479.37
45min11900180-190018087.69387.480.9588.1787.950.94
21900607-190060787.71388.17
31912011-191201188.23988.70
41894203-189420387.41787.89
51904665-190466587.90088.39
61861137-186113785.89186.37
60min11982036-198203691.47192.090.7092.0992.710.70
21996165-199616592.12392.73
31997790-199779092.19892.81
41990649-199064991.86892.48
52020888-202088893.26493.90
61985534-198553491.63292.26
极限12036972-203697294.00691.048.7994.7891.818.71
22058478-205847894.99995.76
32048631-204863194.54495.31
42038568-203856894.08094.85
52033563-203356393.84994.64
61619332-161933274.73275.51
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