非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997072670711704207071870405705960.24
210.997140671704715550.30
单位质量响应值RSD%判断
6423.666510.920.96数据可信
供试品溶液-6042201批-多替诺雷-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%
5min110042-1004213.93213.066.2313.9313.066.23
28356-835611.59311.59
39263-926312.85112.85
49389-938913.02613.03
59730-973013.49913.50
69695-969513.45113.45
10min117451-1745124.21123.563.1024.2323.583.10
216125-1612522.37122.39
316547-1654722.95722.98
417183-1718323.83923.86
517381-1738124.11424.14
617184-1718423.84123.86
15min121812-2181230.26129.641.9730.3229.701.96
220661-2066128.66428.72
321190-2119029.39829.46
421741-2174130.16330.22
521455-2145529.76629.83
621332-2133229.59529.66
20min124674-2467434.23233.891.6634.3534.001.66
224007-2400733.30733.41
324524-2452434.02434.13
424937-2493734.59734.71
524556-2455634.06834.18
623885-2388533.13733.25
30min128500-2850039.54039.451.4139.7139.621.41
227685-2768538.40938.57
328638-2863839.73139.90
428680-2868039.79039.96
528775-2877539.92240.09
628321-2832139.29239.46
45min132714-3271445.38645.240.7545.6245.470.75
232398-3239844.94845.17
332751-3275145.43845.67
432646-3264645.29245.53
532247-3224744.73844.97
632906-3290645.65345.88
60min135488-3548849.23549.000.7549.5549.310.76
234866-3486648.37248.67
335576-3557649.35749.66
435383-3538349.08949.40
535155-3515548.77349.08
635454-3545449.18849.50
90min139093-3909354.23653.850.5954.6354.240.59
238610-3861053.56653.95
338644-3864453.61354.00
438741-3874153.74854.14
539101-3910154.24754.64
638681-3868153.66554.06
120min141375-4137557.40257.130.5857.8957.620.58
240732-4073256.51056.98
341365-4136557.38857.87
441207-4120757.16957.65
541169-4116957.11757.60
641242-4124257.21857.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限141914-4191458.15058.150.4858.7358.720.48
241762-4176257.93958.50
342288-4228858.66959.24
441834-4183458.03958.62
541740-4174057.90958.49
641943-4194358.19058.77
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9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%
110.214807454807844805964809764791704804540.16
210.354969934968164969040.03
单位质量响应值RSD%判断
47057.2048010.051.42数据可信
供试品溶液-6042201批-非布司他-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%
5min14366-43660.8260.818.710.830.828.62
23627-36270.6860.69
34174-41740.7900.79
44433-44330.8390.84
54693-46930.8880.89
64536-45360.8580.86
10min14901-49010.9271.0110.310.931.0110.06
25075-50750.9600.96
35054-50540.9560.96
44993-49930.9450.95
55808-58081.0991.10
66255-62551.1831.18
15min14908-49080.9280.951.740.930.951.72
25068-50680.9590.96
35138-51380.9720.97
45106-51060.9660.97
54972-49720.9410.94
65004-50040.9470.95
20min14867-48670.9211.0320.080.931.0420.21
24655-46550.8810.88
35954-59541.1261.13
47461-74611.4111.42
54632-46320.8760.88
65176-51760.9790.98
30min14908-49080.9280.925.990.930.936.13
24484-44840.8480.85
35251-52510.9931.00
44726-47260.8940.90
55189-51890.9820.99
64766-47660.9020.91
45min14423-44230.8370.946.550.840.946.66
25131-51310.9710.98
35400-54001.0221.03
44952-49520.9370.95
54852-48520.9180.93
64927-49270.9320.94
60min14929-49290.9320.933.750.940.943.86
25004-50040.9470.96
35120-51200.9690.98
44754-47540.8990.91
54615-46150.8730.88
64964-49640.9390.95
90min14668-46680.8830.923.720.890.933.76
24873-48730.9220.93
34941-49410.9350.95
44630-46300.8760.89
55115-51150.9680.98
64852-48520.9180.93
120min14935-49350.9340.914.590.950.924.54
24626-46260.8750.89
34603-46030.8710.88
44830-48300.9140.93
55134-51340.9710.98
64596-45960.8690.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15038-50380.9530.933.680.970.943.77
24991-49910.9440.96
35087-50870.9620.98
44618-46180.8740.89
54887-48870.9240.94
64750-47500.8990.91
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997213472010724397219472378722310.25
210.997273372874728040.14
单位质量响应值RSD%判断
6572.436624.570.56数据可信
供试品溶液-6042201批-多替诺雷-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%
5min19311-931112.66113.187.5412.6613.187.53
211137-1113715.14315.14
39508-950812.92812.93
49595-959513.04713.05
59527-952712.95412.95
69088-908812.35712.36
10min117012-1701223.13223.774.2123.1523.794.21
218775-1877525.52925.55
317375-1737523.62523.65
417844-1784424.26324.28
517166-1716623.34123.36
616726-1672622.74322.76
15min121635-2163529.41829.922.8129.4829.982.81
222905-2290531.14531.21
322083-2208330.02730.09
422515-2251530.61530.68
521629-2162929.41029.47
621259-2125928.90728.97
20min124785-2478533.70134.032.3033.8134.142.31
225840-2584035.13635.26
325010-2501034.00734.12
425427-2542734.57434.69
524924-2492433.89034.00
624157-2415732.84732.95
30min128609-2860938.90139.682.5439.0739.852.54
230523-3052341.50341.68
329090-2909039.55539.72
429483-2948340.08940.26
528860-2886039.24239.41
628542-2854238.81038.97
45min132779-3277944.57144.641.1444.8044.881.15
233081-3308144.98245.23
332943-3294344.79445.03
433252-3325245.21445.45
532775-3277544.56544.80
632168-3216843.74043.97
60min135302-3530248.00248.280.8048.3148.590.80
235611-3561148.42248.74
335608-3560848.41848.73
435967-3596748.90649.22
535383-3538348.11248.42
635182-3518247.83848.14
90min138797-3879752.75452.980.8153.1453.370.82
239131-3913153.20853.61
339213-3921353.31953.71
439272-3927253.40053.79
538922-3892252.92453.31
638435-3843552.26252.64
120min141322-4132256.18755.900.5756.6656.370.55
240727-4072755.37855.87
341057-4105755.82756.30
441091-4109155.87356.36
541375-4137556.25956.73
641075-4107555.85156.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限141902-4190256.97656.800.7757.5457.370.75
241462-4146256.37856.96
342238-4223857.43358.00
441429-4142956.33356.91
541640-4164056.62057.19
641982-4198257.08557.64
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9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%
110.214963964975084969094964054978994970230.14
210.355053235048475050850.07
单位质量响应值RSD%判断
48680.0248800.480.18数据可信
供试品溶液-6042201批-非布司他-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%
5min14335-43350.8000.792.570.800.792.48
24391-43910.8100.81
34214-42140.7770.78
44121-41210.7600.76
54394-43940.8110.81
64341-43410.8010.80
10min14447-44470.8200.886.480.820.886.40
24484-44840.8270.83
34596-45960.8480.85
45164-51640.9530.95
55023-50230.9270.93
64973-49730.9170.92
15min15133-51330.9470.9915.710.950.9915.72
25104-51040.9420.94
37040-70401.2991.30
44802-48020.8860.89
54941-49410.9110.91
65050-50500.9320.93
20min15058-50580.9330.947.390.940.947.42
24793-47930.8840.89
34811-48110.8870.89
45068-50680.9350.94
55815-58151.0731.08
64996-49960.9220.93
30min14763-47630.8791.0225.760.881.0225.85
28414-84141.5521.56
35121-51210.9450.95
44855-48550.8960.90
54864-48640.8970.90
65126-51260.9460.95
45min14675-46750.8620.914.020.870.923.71
24938-49380.9110.92
35014-50140.9250.93
44705-47050.8680.88
55188-51880.9570.96
65002-50020.9230.93
60min14767-47670.8790.874.030.890.883.76
24720-47200.8710.88
35014-50140.9250.93
44837-48370.8920.90
54543-45430.8380.85
64498-44980.8300.84
90min14944-49440.9120.9313.680.920.9413.49
24553-45530.8400.85
34875-48750.8990.91
44308-43080.7950.81
55194-51940.9580.97
66278-62781.1581.17
120min14347-43470.8020.846.260.810.866.23
24491-44910.8280.84
34600-46000.8490.86
44802-48020.8860.90
54980-49800.9190.93
64213-42130.7770.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限13933-39330.7260.869.260.740.889.03
25039-50390.9300.94
34916-49160.9070.92
44382-43820.8080.82
54985-49850.9200.93
64780-47800.8820.90
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997167671980722417197971943719640.28
210.997243872549724940.11
单位质量响应值RSD%判断
6548.136596.360.52数据可信
供试品溶液-6042401批-多替诺雷-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%
5min17976-797610.88911.1210.2710.8911.1210.26
29619-961913.13213.13
38108-810811.06911.07
48379-837911.43911.44
57161-71619.7769.78
67624-762410.40810.41
10min116645-1664522.72322.633.2722.7422.653.28
217187-1718723.46323.49
315996-1599621.83721.86
417226-1722623.51623.54
516038-1603821.89521.91
616378-1637822.35922.38
15min121503-2150329.35529.151.4729.4129.201.47
221603-2160329.49229.55
320840-2084028.45028.50
421620-2162029.51529.57
521104-2110428.81128.86
621431-2143129.25729.31
20min124616-2461633.60533.421.2033.7133.521.21
224878-2487833.96334.07
324449-2444933.37733.48
424634-2463433.63033.74
524100-2410032.90133.00
624188-2418833.02133.12
30min128945-2894539.51539.000.9839.6839.160.99
228776-2877639.28439.45
328496-2849638.90239.06
428640-2864039.09839.26
528188-2818838.48138.64
628344-2834438.69438.85
45min132856-3285644.85444.420.8645.0844.650.86
232746-3274644.70444.94
332401-3240144.23344.46
432669-3266944.59944.83
532479-3247944.33944.56
632091-3209143.81044.03
60min135716-3571648.75848.121.0049.0648.421.00
235239-3523948.10748.41
335232-3523248.09848.39
435362-3536248.27548.58
535296-3529648.18548.48
634632-3463247.27847.57
90min139014-3901453.26152.790.6653.6453.170.65
238684-3868452.81053.20
338696-3869652.82753.20
438683-3868352.80953.19
538702-3870252.83553.21
638223-3822352.18152.56
120min141229-4122956.28555.870.6856.7656.340.68
240901-4090155.83756.31
340982-4098255.94756.41
440870-4087055.79456.27
541118-4111856.13356.60
640432-4043255.19655.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限141820-4182057.09156.920.8357.6657.480.82
241424-4142456.55157.12
342084-4208457.45258.01
441166-4116656.19856.76
541708-4170856.93857.49
641959-4195957.28157.83
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9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%
110.215004675000905000095001965007235002970.06
210.355116715118395117550.03
单位质量响应值RSD%判断
49000.6949444.930.64数据可信
供试品溶液-6042401批-非布司他-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%
5min13135-31350.5730.5913.730.570.5813.71
23675-36750.6710.67
33829-38290.6990.70
42859-28590.5220.52
52830-28300.5170.52
62896-28960.5290.53
10min14479-44790.8180.833.570.820.833.62
24506-45060.8230.82
34800-48000.8770.88
44376-43760.7990.80
54486-44860.8190.82
64712-47120.8610.86
15min15010-50100.9150.887.720.920.897.81
25236-52360.9560.96
34606-46060.8410.84
45027-50270.9180.92
54204-42040.7680.77
64981-49810.9100.91
20min14323-43230.7900.8814.200.790.8914.20
25557-55571.0151.02
35849-58491.0681.07
44663-46630.8520.86
54480-44800.8180.82
64200-42000.7670.77
30min14529-45290.8270.825.120.830.835.12
24928-49280.9000.91
34332-43320.7910.80
44276-42760.7810.79
54493-44930.8210.83
64451-44510.8130.82
45min14415-44150.8060.859.910.810.869.87
24619-46190.8440.85
34426-44260.8080.82
45595-55951.0221.03
54547-45470.8310.84
64408-44080.8050.81
60min14371-43710.7980.8815.610.810.8815.23
24342-43420.7930.80
34965-49650.9070.92
44643-46430.8480.86
56218-62181.1361.14
64220-42200.7710.78
90min14544-45440.8300.8811.300.840.8811.39
24880-48800.8910.90
34571-45710.8350.84
44580-45800.8370.85
55845-58451.0681.08
64352-43520.7950.80
120min14438-44380.8110.806.730.820.826.89
24416-44160.8070.82
34737-47370.8650.88
44047-40470.7390.75
54701-47010.8590.87
64072-40720.7440.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14748-47480.8670.866.040.880.885.85
25128-51280.9370.95
34821-48210.8810.89
44241-42410.7750.79
54765-47650.8700.88
64695-46950.8580.87
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